Study of Hyperkyphosis, Exercise and Function-SHEAF
Phase: NA
Conditions: Kyphosis
Sponsor: University of California, San Francisco

Study of Hyerkyphosis, Exercise and Function 
-SHEAF  Protocol, Version 1.0
1 
Study of Hyperkyphosis, Exercise and Function - SHEAF 
Protocol  
08/03/2012
NCT01751685

Study of Hyerkyphosis, Exercise and Function 
-SHEAF  Protocol, Version 1.0
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PREFACE 
Study of Hyperkyphosis, Exercise and Function - SHEAF 
Principal Investigator:   
Wendy Katzman, PT, DPTSc, OCS 
Supported by:  
NIH National Institute on Aging 
Project Number: 
P0046955  
Version 1 12.7.12 

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-SHEAF  Protocol, Version 1.0 
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TABLE OF CONTENTS  
Page 
STUDY TEAM ROSTER .............................................................................................. 6 
PARTICIPATING STUDY SITES .................................................................................. 5 
PRÉCIS ....................................................................................................................... 8 
1. Study objectives ..................................................................................................... 10 
1.1 Primary Objective ................................................................................................ 10 
1.2 Secondary Objectives .......................................................................................... 10 
2. BACKGROUND AND RATIONALE ......................................................................... 11 
2.1 Background on Condition, Disease, or Other Primary Study Focus ..................... 11 
2.2 Study Rationale ................................................................................................... 12 
3. STUDY DESIGN .................................................................................................... 14 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 15 
4.1 Inclusion Criteria .................................................................................................. 15 
4.2 Exclusion Criteria ................................................................................................. 13 
4.3 Study Enrollment Procedures .............................................................................. 15 
5. STUDY INTERVENTIONS ..................................................................................... 16 
5.1 Interventions, Administration, and Duration ......................................................... 16 
5.2 Handling of Study Interventions ........................................................................... 18 
5.3 Adherence Assessment ....................................................................................... 18 
6. STUDY PROCEDURES ......................................................................................... 19 
6.1 Schedule of Evaluations ...................................................................................... 19 
6.2 Description of Evaluations ................................................................................... 19 
7. SAFETY ASSESSMENTS ...................................................................................... 21 
7.1 Specification of Safety Parameters ...................................................................... 21 

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7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters ................................................................................................................ 21 
7.3 Adverse Events and Serious Adverse Events ...................................................... 21 
7.4 Reporting Procedures .......................................................................................... 22 
7.5 Follow-up for Adverse Events .............................................................................. 22 
7.6 Safety Monitoring ................................................................................................. 23 
8. INTERVENTION DISCONTINUATION ................................................................... 23 
9. STATISTICAL CONSIDERATIONS ........................................................................ 24 
9.1 General Design Issues......................................................................................... 24 
9.2 Sample Size and Randomization ......................................................................... 24 
9.2.1 
Treatment Assignment Procedures .......................................................... 25 
9.3 Interim analyses and Stopping Rules................................................................... 25 
9.4 Outcomes ............................................................................................................ 27 
9.4.1 
Primary outcome ...................................................................................... 28 
9.4.2 
Secondary outcomes ............................................................................... 28 
9.5  Data Analyses ..................................................................................................... 30 
10. DATA COLLECTION AND QUALITY ASSURANCE .............................................. 31 
10.1 Data Collection Forms ....................................................................................... 31 
10.2 Data Management ............................................................................................. 31 
10.3 Quality Assurance .............................................................................................. 31 
10.3.1 
Training .................................................................................................... 32 
10.3.5 
Monitoring ................................................................................................ 32 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................ 32 
11.1 Institutional Review Board (IRB) Review ........................................................... 33 
11.2 Informed Consent Forms ................................................................................... 33 
11.3 Participant Confidentiality .................................................................................. 33 
11.4 Study Discontinuation ........................................................................................ 33 
12. COMMITTEES ..................................................................................................... 34 
13. PUBLICATION OF RESEARCH FINDINGS .......................................................... 34 
14. REFERENCES..................................................................................................... 34 

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15. SUPPLEMENTS/APPENDICES ........................................................................... 42 
 
I. Procedures Schedule 
  
II. Informed Consent Form  
  
III. Other  
 
1.  PROMIS Global Health Questionnaire 
 
2.  PROMIS Physical Function Questionnaire 
 
3.  Scoliosis Patient Questionnaire 
 
4. Adverse Event (AE) Report Form 
 
5. Serious Adverse Event (SAE) Report Form 
 
6. Telephone Screen 
 
7. Clinic Screen 
 
8. Medical History 
 
9. Demographics 
 
10. Testing Kyphosis and Strength 
 
11. Testing Physical Performance 
 
12. Physical Activity Survey 
 
13. Weekly Log 
 

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STUDY TEAM ROSTER  
  
Wendy Katzman, PT, DPTSc, OCS (Principal Investigator) 
Associate Professor 
University of California, San Francisco 
Department of Physical Therapy and Rehabilitation Science 
1500 Owens Street, Suite 400  
San Francisco, CA 94158-2332 
Telephone: (415) 514-6772 Fax: (415) 514-6778 
Wendy.Katzman@ucsfmedctr.org 
 
Anne Schafer, MD (Co- Investigator) 
Assistant Adjunct Professor 
University of California, San Francisco 
San Francisco VA Medical Center 
Department of Medicine and Endocrinology 
4150 Clement Street 
San Francisco, CA 94143 
Telephone:  415-221-4810 x4895 
Anne.Schafer@ucsf.edu 
 
Eric Vittinghoff, PhD, MPH (Co- Investigator) 
Adjunct Professor 
University of California, San Francisco 
Division of Biostatistics 
China Basin Landing 
185 Berry Street, Lobby 5, Suite 5700 
San Francisco, CA 94107-1762  
Telephone:  415-514-8025 Fax: 415-514-8150 
eric@biostat.ucsf.edu 
 
Nancy Lane, MD (Co-Investigator) 
Professor 
University of California, Davis 
UC Davis Center for Healthy Aging 
4800-2nd Avenue, Suite 1600 
Sacramento, CA 95817 
Telephone:  916-734-4534 Fax: 916-734-4773 
Nancy.land@ucdmc.ucdavis.edu 
 
 
 
 
 
 
 
 

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Deborah Kado, MD (Co-Investigator) 
Associate Professor 
University of California, San Diego 
FPM and IM, Endocrinology 
9500 Gilman Drive 
La Jolla, CA 92093 
Telephone:  858-534-4309 
dkado@ucsd.edu 
  
Roger Long, MD (Co-Investigator) 
Associate Clinical Professor 
University of California, San Francisco 
Department of Medicine and Endocrinology 
Roger.long@ucsf.edu 
 
Shirley Wong (Study Coordinator) 
Department of Physical Therapy and Rehabilitation Science 
1500 Owens Street, Suite 400  
San Francisco, CA 94158-2332 
Telephone: (415) 514-6772 Fax: (415) 514-6778 
wongs@ptrehab.ucsf.edu 
 
 
PARTICIPATING STUDY SITES  
  
UCSF Clinical Research Services – Moffitt Hospital  
(Screening and Testing Site) 
Deanna Sheeley, RN 
Nurse Manager & Adult Moffitt Contact 
Telephone:  415-353-1330 
dsheeley@gcrc.ucsf.edu 
 
Mission Bay – PhysFit  Physical Therapy Health & Wellness Center (Intervention Site) 
1675 Owens Street 
Bakar Fitness Center, Mission Bay 
San Francisco, CA 94158 
Telephone: 415-514-4816 Fax: 415-514-4817 
email: wellness@ptrehab.ucsf.edu 
 
San Francisco VA Medical Center  (Intervention Site - PENDING) 
4150 Clement Street 
San Francisco, CA 94143 
Telephone:  415-221-4810 x4895 
 
 
 
 

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Kaiser Permanente Medical Center French Campus   
(Intervention Site - PENDING) 
450-6th Avenue 
San Francisco, CA 94118 
 
UCSF Osher Center for Integrative Medicine   
(Intervention Site - PENDING) 
1545 Divisadero Street, 4th Floor 
San Francisco, CA 94115-3010 
Telephone:  415-353-7700 
 
PRÉCIS  
  
Study Title  
Study of Hyerkyphosis, Exercise and Function-SHEAF 
Objectives  
Our long-term goal is to develop interventions to delay functional decline and 
physical disability in older adults. Exercise interventions targeted at increasing 
function in older adults often neglect posture and spinal muscle weakness. We 
propose a paradigm where we can improve physical function in an exercise 
intervention targeted at reducing hyperkyphosis, which may reduce associated 
disability.  
 
Design and Outcomes   
 
We propose to conduct a randomized, controlled trial among 100 men and 
women aged 60 or older with hyperkyphosis to an exercise intervention that 
includes kyphosis-specific spinal muscle strengthening exercises compared to 
a non-kyphosis specific stretching exercise control. The study will be conducted 
in five waves, with 10 participants in the exercise intervention and 10 
participants in the control group in each wave.  
The experimental and control interventions will be provided in small groups 
meeting three sessions per week for 6 months. At baseline and 6 months after 
the intervention, we will measure kyphosis, physical function, spine muscle 
strength and density, and quality of life.  
We will assess the effect of the intervention on the co-primary outcomes of 
kyphosis, modified PPT (PPT) and gait speed measured as change over 6 
months. We will also assess the effect of the intervention on secondary 
outcomes of physical function and HRQOL, measured as change in Timed Up 
and Go, Timed Loaded Standing, Six-Minute Timed Walk, the Scoliosis 

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Research Society SRS-30 (self image domain only) and the PROMIS Physical 
Function and Global Health Index.  
Furthermore, we will investigate whether changes in kyphosis, spinal muscle 
strength and/or density mediate the effect of the intervention on change in 
physical function. After the 6-month intervention, both groups will continue their 
usual activity and we will assess the durability of the effects of the intervention 
at 1-year follow-up.  
Interventions and Duration  
Participants assigned to the intervention group will receive a kyphosis-specific 
spinal strengthening group exercise program for 1 hour three times per week for 
6 months, followed by 6 months of usual activity. The participants assigned to 
the control group will receive a non-kyphosis specific stretching group program 
for 1 hour three times per week for 6 months, followed by 6 months of usual 
activity. The intervention and the control group sessions will be conducted in 
small groups at study intervention sites. A licensed physical therapist will teach 
the kyphosis-specific strengthening exercise intervention and a different 
physical therapist will teach the stretching intervention. Physical therapy 
students and/or research assistants will help ensure the safety of all 
participants and maintain a ratio of no more than 5 participants to 1 teacher. 
Sample Size and Population  
One hundred subjects of men and women age 60 years and older and with 
kyphosis of ≥ 40° will be recruited for this study. In our pilot study, we observed 
a 2 standard deviation (SD) improvement in kyphosis of 6°.42 Allowing for 
improvements in the control group due to regression to the mean, loss to follow-
up of 10% of participants, chance under-estimation of the SD of the change in 
the pilot, and attenuation of the treatment effect due to the imputation 
procedure, the proposed combined sample size of 100 will provide 80% power 
in 2-sided tests with a type-I error rate of 5% if the between-group difference in 
mean kyphosis improvements is at least 50% of the SD of the changes; this 
calculation accounts for the correlation of the pre- and post-intervention 
measurements (0.8 for both kyphosis and PTT scores in the pilot study), which 
will improve efficiency by reducing residual error in the proposed ANCOVA 
analysis procedure. The pilot study gives strong evidence that these conditions 
will be met. Similarly, we observed a 1-SD improvement of 2 points in the co-
primary PPT endpoint. Thus the study will also be well powered to detect an 
effect on PTT scores under similarly conservative assumptions about the effect 
size and retention.   
 
 
 

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1. STUDY OBJECTIVES 
1.1 Primary Objective  
We propose 3 specific aims in a randomized controlled trial comparing a 6-month 
high-intensity kyphosis-specific spinal strengthening exercise intervention to a 
control stretching intervention in community-dwelling adults 60 years and older with 
hyperkyphosis. 
The exercise intervention will improve hyperkyphosis, as measured by Cobb angle 
from lateral spine radiographs. The exercise intervention will also improve physical 
function, as measured by the Modified Physical Performance Test, gait speed, 
timed loaded standing and spinal extensor muscle strength. 
Specific Aim 1: To determine if the exercise intervention improves kyphosis, the 
Modified Physical Performance Test (PPT) and gait speed in person with 
kyphosis 
 
 
Hypothesis 1: We hypothesize that the co-primary outcomes of kyphosis, 
measured as Cobb angle using lateral spine radiographs, and physical 
function, measured as the Modified Physical Performance Test and gait 
speed, will improve after the 6-month intervention. 
1.2 Secondary Objectives 
Specific Aim 2: Determine if the exercise intervention improves secondary 
measures of physical function, and health-related quality of life (HRQoL) . 
Hypothesis 2:  We hypothesize that secondary measures of physical 
function, including Timed Up and Go, Timed Loaded Standing, and 
HRQOL, measured as the Scoliosis Research Society SRS-30 (self 
image domain) and PROMIS Physical Function and Global Health Index, 
will improve after the 6-month intervention. 
Specific Aim 3: Determine if the exercise intervention improves spinal muscle 
strength and/or spinal muscle density and if changes in spinal extensor muscle 
strength and/or density mediate the effects of change in kyphosis on physical 
function.   
 
Hypothesis 3: We hypothesize that spinal muscle strength, measured 
with a Biodex computerized dynamometer, and spinal muscle density, 
measured with quantitative computed tomography, will improve after the 

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6-month intervention. We hypothesize that the intervention will have 
direct effects on function, as well as indirect effects on function via 
kyphosis, muscle strength, and density; we also hypothesize an indirect 
effect of the intervention on kyphosis via strength and density. 
 
2. BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Hyperkyphosis is a highly prevalent condition among elderly persons. While a small 
amount of anterior curvature of the thoracic spine (kyphosis) is normal due to the 
shape of the vertebral bodies and intervertebral discs, a thoracic curvature between T4 
and T12 that is greater than 40 degrees is defined as hyperkyphosis.23 Persons with 
hyperkyphosis have a global misalignment of the spine, measured as a plumb line 
from C7 to S1 falling in front of the sacral promontory.7, 25 Several methods quantify 
kyphosis, including lateral radiographic Cobb angle of kyphosis (the gold standard), 
and clinical measures including Debrunner kyphometer,26 supine block method for 
forward head alignment,27 occiput to wall distance,7 electric inclinometer,28 and 
flexicurve kyphosis index.29 There is a strong correlation between radiographic Cobb 
angle and Debrunner kyphometer measures of kyphosis and these are often used 
interchangeably.26, 30 Reports of prevalence of hyperkyphosis in older adults vary from 
approximately 20% to 40% among men and women.11, 24 It is estimated that kyphosis 
angle is 6 - 11% higher per decade of life among women age 55-80 years,31 and 
kyphosis increases 7 degrees over 15 years among women in the longitudinal Study of 
Osteoporotic Fractures.32 
Hyperkyphosis is not synonymous with spinal osteoporosis. It is often assumed that 
hyperkyphosis is caused solely by osteoporosis and vertebral fractures, but only a 
third of individuals with severe hyperkyphosis have radiographic vertebral fractures.17, 
27 In fact, recent evidence suggests that impairments in spinal muscle composition, 
strength, mobility and alignment are important determinants of the degree of 
kyphosis.35-38 Higher multisegmental spinal loads and trunk muscle forces are present 
in the hyperkyphotic vs. normal spine,39 and improving the biomechanics of spinal load 
and muscle force distribution could potentially ameliorate the detrimental effects of 
kyphosis and slow kyphosis progression. To date, small studies have demonstrated 
that kyphosis-related impairments can be targeted with exercise, but none have 
established whether reducing these impairments prevents kyphosis progression, or 
leads to improvement in physical function. 
 Spinal muscle weakness. Spinal extensor muscle strength is an important 
independent determinant of degree of kyphosis in older adults.3, 33 Recent 
studies demonstrate that spinal extensor muscle strength can be increased with 
targeted strengthening,4, 34-37 however the effects on kyphosis have been 
inconsistent. The only large randomized exercise trial did not improve Cobb 
angle or Debrunner kyphometer kyphosis.35 High-intensity strengthening rather 
than low-intensity or yoga-type exercise may be necessary to reduce the Cobb 
angle or Debrunner kyphosis.  
 Spinal muscle fat infiltration. We examined fat infiltration in the spinal extensor 

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muscles on quantitative computed tomography (CT) among healthy community-
dwelling older men and women and found lower spinal muscle density (a proxy 
measure of fat infiltration) among older adults with hyperkyphosis.38 
Furthermore, lower spinal muscle density is a known predictor of impaired 
physical function in older adults,39, 40 suggesting that improved muscle quality is 
a possible mechanism for improving physical function that we will investigate in 
our study. 
 Spinal mobility. Decreased spinal mobility interferes with the ability to stand erect 
and maintain optimal postural alignment.41 Schenkman, et al. determined that 
hyperkyphosis results in the loss of combined spinal extension and rotation 
mobility which is highly correlated with impaired physical performance.42 
Furthermore, short pectoral and hip flexor muscles are linked to severe 
hyperkyphosis,7 although it is not known whether the short muscles pull the 
shoulders and hips anteriorly, increasing kyphosis, or whether the kyphosis 
results in shorter anterior musculature.  
 Spinal alignment. Hyperkyphosis may be partially attributed to poor postural 
habits. Postural taping produced immediate reduction in kyphosis, although it 
was not sustained without mechanical support from the tape.43 Specific postural 
training,44 combined with strengthening,5 might be most effective. 
 
Exercise trials to reduce hyperkyphosis are limited. Several randomized studies40-
42, 49 of physical activity interventions have demonstrated improvement in clinical 
measures of kyphosis, but none has demonstrated a link between improvement in 
kyphosis and change in physical function. None of these trials used high intensity 
spinal extensor strengthening to reduce hyperkyphosis while targeting all known 
musculoskeletal impairments associated with hyperkyphosis21. 
 
2.2 Study Rationale 
2.3 Exercise trials to improve physical function in the elderly are feasible and 
effective. There is strong evidence from 121 randomized controlled trials reviewed 
in a Cochrane Collaboration meta-analysis that people aged 60 years and older 
who perform resistance exercises become stronger (standardized mean difference 
(SMD)=0.84, 95% CI 0.67 to 1.00) and improve their physical function (SMD=0.14, 
95% CI 0.05 to 0.22).50 The majority of these resistance exercise programs target 
lower extremity muscle groups, and none of these trials targeted the spinal 
muscles or hyperkyphosis. Lower extremity resistance exercise is effective in 
improving walking speed (SMD=0.08 m/s, 95% CO 0.04 to 0.12) and rising from a 
chair (SMD -0.94, 95% CI -1.49 to -0.38.50 In subgroup analyses, when high 
intensity resistance exercise was compared to low intensity training, both are 
effective; however, high-intensity training has a larger effect on strength than low 
intensity training (SMD=0.48, 95% CI 0.03 to 0.93; test for subgroup differences, 
p=0.07).51, 52,53, 54,55, 56,57, 58,59 Even individuals in their 80’s benefit from high-
intensity resistance exercise and are capable of improving strength and physical 

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function. Among 100 frail nursing home residents, mean age 87±0.6 years, lower 
extremity high-intensity resistance exercise 3 times a week for 10 weeks increased 
lower extremity strength 113±3.8%, gait speed 28±3.8% and stair climbing 
28±6.6%.60 Furthermore, serious adverse effects from high intensity resistance 
exercise are rare when used appropriately in older adult populations.50 While 
musculoskeletal complaints such as joint pain and muscle soreness were reported 
in many studies, no serious events related to the exercise interventions were 
reported in the meta-analysis of 121 trials of progressive resistance strength 
training in older adults.50 
Unfortunately, these trials did not focus on older adults with hyperkyphosis, and it is 
not clear if the findings can be generalized to this group. Furthermore, these trials did 
not target spinal muscle strength that can be amenable to intervention. High-intensity 
spinal extensor strengthening exercise has not been well investigated in older adults 
with hyperkyphosis. In contrast, in an uncontrolled trial we demonstrated that a high-
intensity spinal extensor strengthening exercise intervention improved spinal extensor 
muscle strength, reduced kyphosis, and improved physical function for elders with 
hyperkyphosis.4The benefit of reducing hyperkyphosis on physical function has not 
been demonstrated in a full-scale randomized controlled trial. Additionally, no clinical 
trials have investigated whether exercise that improves kyphosis, spinal muscle 
strength and/or spinal muscle density predicts improved physical function. 
In Dr. Katzman’s pilot trial, after 12-weeks of training, we observed a 6° decrease in 
Debrunner kyphosis, an 11% improvement from baseline and exceeding the amount 
of progression in kyphosis typically observed over a decade in older females.21  In 
addition to improvement in kyphosis, physical function improved 2 points (p<0.001) on 
the Modified Physical Performance Test, a 9-item composite test of physical 
performance, and 1.4 seconds (p<0.001) on the jug test (p<0.001), a timed lifting test 
(table1).[21]  Improved kyphosis and gains in physical function were maintained 1 year 
after the participants completed the intervention.22, 65  Dr. Katzman was responsible for 
all phases of the study, including conceptualization, design, development of forms, 
recruitment, implementation, data management, and analysis and presentation of 
results. 
TABLE 1. CHANGE IN KYPHOSIS, STRENGTH, AND PHYSICAL FUNCTION 
AFTER 12-WEEKS 
Kyphosis  
change ± sd 
p-value 
Debrunner kyphosis (degrees) 
-6 ± 3 
<.001* 
Strength  
Biodex spinal extensor strength (% body weight) 
21 ± 13 
<.001* 
Physical function 
Jug test (seconds) 
-1.4 ± 1.3 
.001* 
Modified Physical Performance Test (36-points) 
2 ± 2 
.001* 
Gait speed (meters/second) 
0.05 ± 0.10 
.06 

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*p<0.05 
Feasibility and retention in the pilot trial:  It was feasible to recruit participants for the 
pilot trial, screen by telephone and a clinic screening visit, and enroll prior to a 
baseline examination. Our recruitment methods included posting flyers at local clinics, 
hospitals, and senior community centers. Over 1 year, we screened a total of 189 
people by phone, of whom 93 (49%) were eligible to attend the screening visit. Of 
these eligible participants, 92 (48%) attended the clinic screening visit, which included 
measurement of kyphosis and a cognitive screening exam. A total of 36 (39%) 
persons screened at the clinic visit fulfilled study eligibility criteria and were invited to 
enroll in the study. Eleven (30%) declined participation, and 25 participants were 
enrolled in the study. Four participants withdrew during the study, 3 due to nonstudy-
related injuries and 1 withdrew because of a family emergency. Of the 25 enrolled in 
the study, 21 (84%) completed the trial. 
Adherence in the pilot trial: we measured adherence to the exercise intervention by 
attendance at the classes and by self-reported frequency of practice of home spinal 
alignment. We requested that all participants enrolled attend 24 classes over the 
course of the 12-week pilot trial; we provided four make-up classes to accommodate 
absences. We requested that participants practice ideal spinal alignment 3 times a 
day. Each participant was given a log in which to record each practice session. 
Adherence to group exercise classes was exceptional. Other than those who withdrew 
because of unrelated injuries or family emergency, all participants completed 24 
sessions and exceeded the required 3-times-per-day home spinal alignment practice. 
Participants were asked for feedback about the study at the 1-year follow-up visit, and 
all reported a newfound sense of confidence walking with improved spinal alignment. 
 
3. STUDY DESIGN  
Overview. We propose to conduct a randomized, controlled trial among 100 men and 
women aged 60 or older with hyperkyphosis to an exercise intervention that includes 
kyphosis-specific spinal muscle strengthening exercises compared to a non-kyphosis 
specific stretching exercise control. The study will be conducted in five waves, with 10 
participants in the exercise intervention and 10 participants in the control group in 
each wave.  
 
The experimental and control interventions will be provided in small groups meeting 
three sessions per week for 6 months. At baseline and 6 months after the intervention, 
we will measure kyphosis, physical function, spine muscle strength and density, and 
quality of life. We will assess the effect of the intervention on the co-primary outcomes 
of kyphosis, Modified PPT (PPT) and gait speed measured as change over 6 months. 
We will also assess the effect of the intervention on secondary outcomes of physical 
function and HRQOL, measured as change in Timed Up and Go, Timed Loaded 
Standing, Six-Minute Timed Walk, the Scoliosis Research Society SRS-30 (self image 
domain) and PROMIS Physical Function and Global Health. Furthermore, we will 
investigate whether changes in kyphosis, spinal muscle strength and/or density 

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mediate the effect of the intervention on change in physical function. After the 6-month 
intervention, both groups will continue their usual activity and we will assess the 
durability of the effects of the intervention at 1-year follow-up. 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 and 4.2 Inclusion and Exclusion Criteria 
Study participants. The study population consists of 100 community-dwelling men 
and women aged 60 years and older with kyphosis ≥40 degrees measured by 
Debrunner kyphometer (Proteck AG, Berne, Switzerland), a protractor-like tool 
placed over the T4 and T12 spinous processes to measure kyphosis externally.28   
Eligibility criteria: Participant eligibility will be assessed with a telephone interview, 
a clinical screening visit, and subsequently during a telephone screening with the 
participant’s primary care provider. If the participant’s primary care provider does 
not approve participation, or if they do not have a provider, and is unwilling to see a 
primary care provider, they will be excluded from the study. 
We will exclude for: 1) advanced disability or end-stage disease, 2) no active 
movement in thoracic spine, 3) unable to execute exercise safety tests, 4) failure to 
comply with run-in procedures: poor attendance, non-compliant with wearing a 
pedometer, 5) major psychiatric illness, cognitive impairment, or substance abuse, 6) 
uncontrolled hypertension, diagnosed vestibular or neurologic disorder, total hip or 
knee replacement or hip fracture within the previous 12 months, oral glucocorticoid 
medications for 6 weeks or more the past year, unexplained weight loss (>10 pounds 
in the past year), gait speed <0.6 m/s, painful vertebral fractures in the past 6 months 
or 3 or more falls in the past year, and 7) non-English speaking. 
 
4.3  Study Enrollment Procedures  
 
Recruitment: Participants will be recruited by referral from their physician and through 
posted announcements in the University of California San Francisco (UCSF) 
Collaborative Research Network (CRN) of local senior clinics and community sites. 
The CRN will develop a strategy to maximize participant recruitment in each 
participating network clinic, and design appropriate recruitment flyers. Participants will 
be recruited from 1) network clinics including Potrero Hill Health Center, Southeast 
Health Center and the Coleman Clinic, Silver Avenue Clinic, and the primary care 
clinics at San Francisco General Hospital and Lakeshore Primary Care Clinic, 2) 
community senior programs at Self-Help for the Elderly, and 3) providers in the UCSF 
Department of Orthopedics Spine Clinic and the Veterans Affairs Medical Center 
(VAMC) 4)  providers at Kaiser Permanente San Francisco (pending)  and 5)  UCSF 
Osher Center for Integrative Medicine (pending).   

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Obtaining informed consent and enrollment of subjects: After a participant is screened 
by telephone, they will be invited to attend a group orientation and, an individual 
screening visit will be scheduled. At this screening visit, Dr. Katzman and a research 
assistant will explain the study, obtain informed consent, and screen for additional 
criteria (kyphosis ≥40 degrees, active movement in the thoracic spine, gait speed 
≤0.6m/s and unable to execute exercise safety tests). Once they meet initial screening 
criteria Drs. Long and Shafer will screen for additional medical criteria and contact 
their primary care provider before enrolling eligible participants in the study.  
5. STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
Intervention  
Participants assigned to the intervention group will receive a kyphosis-specific 
spinal strengthening group exercise program for 1 hour three times per week for 
6 months, followed by 6 months of usual activity. The participants assigned to 
the control group will receive a non-kyphosis specific stretching group program 
for 1 hour three times per week for 6 months, followed by 6 months of usual 
activity. The intervention and the control group sessions will be conducted in 
small groups at the study sites. A licensed physical therapist will teach the 
kyphosis-specific strengthening exercise intervention and a different physical 
therapist will teach the stretching intervention. Physical therapy students and/or 
research assistants will help ensure the safety of all participants and maintain a 
ratio of no more than 5 participants to 1 teacher.  
 
• 
Intervention: Kyphosis-specific spinal strengthening exercises: We 
developed the intervention protocol of targeted spine exercises during our pilot 
study based upon the literature and clinical experience.3, 7, 35, 38, 47 We 
standardized the protocol with a written script and a video. Each exercise 
session will be preceded by light aerobic activity, ended with cool-down and 
stretching the neck, chest and all extremities. All participants will be carefully 
monitored to ensure that all exercises will be performed slowly, with correct 
body alignment and technique to minimize risk of injury. 
 
Kyphosis-specific exercises include progression to high-intensity spinal 
extensor muscle strengthening, spinal mobilization, and postural alignment 
training (Table 3). The exercises target multiple musculoskeletal impairments 
that are known to be associated with hyperkyphosis, including spinal extensor 
muscle weakness,3, 38 decreased spinal mobility,35, 47 and poor postural 
alignment.7  
 
The strengthening regimen incorporates progression to high-intensity 
strengthening exercise at a Borg Scale intensity of 15-17, based upon 70-80% 
of perceived exertion.76 A 70-80% rating of perceived exertion (RPE) is the 
stimulus recommended to produce significant strength gains, and often results 

Study of Hyerkyphosis, Exercise and Function 
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in improved endurance, in upper and lower extremity muscles in older adults.76-
79 We will implement a graduated protocol the first 10 weeks beginning without 
resistance the first month, while participants learn the exercises, and 
progressing the exercise intensity with theraband or resistance with weights to 
light (30-40%), moderate (50-60%), then high (70-80%) intensity resistance. We 
will progress intensity at 3-week intervals allowing time for periodization.80 
When exercising at a Borg Scale intensity of 15-17, within the first 2 repetitions, 
one typically rates the level of difficulty as “somewhat hard” to “hard”.81, 82 If the 
participant rates the difficulty less than “somewhat hard”, the resistance will be 
increased, or if the participant rates difficulty as more than “hard”, resistance 
will be reduced. The goal is to perform 2 sets of good quality movement in the 
range of 70-80% of maximum until momentary muscle fatigue at 8-12 
repetitions.83, 84 Weights will be increased from one pound, in one-pound 
increments, and theraband resistance will be increased, progressing from 
yellow to red to green to blue theraband (corresponding to 2 to 10 pounds of 
force for each percentage of theraband strain).85 Resistance will be increased 
throughout the trial to maintain a “somewhat hard” to “hard” level of exertion.  
 
The spinal mobilization regimen incorporates foam rollers and end-range 
exercises to increase spinal extension and rotation, and reduce mobility 
limitations in the anterior shoulders, chest and spine.4, 86, 87 Participants will lie 
supine on foam rollers, and perform sidelying and standing end-range thoracic 
extension and rotation to mobilize the spine during exercise.4  
 
The spinal alignment regimen aims to integrate improvements in spinal 
extensor strength and spinal mobility into practice.4 The instructor will train 
participants to recognize correct spinal alignment and maintain their best spinal 
alignment during the group exercise program and during activities of daily living.  
 
Table 2. Exercise Intervention 
 
Kyphosis-specific 
Exercise 
Kyphosis-specific  
exercise 
Non-kyphosis 
specific exercise 
Spinal strengthening 
exercises  
2 sets of 8-12 repetitions 
progressed to 70-80% 
RPE; 0 – 5# weights or 
theraband 
Spinal mobility exercises  
Passive 30 second hold 
Warm-up  
Increase core 
temperature with 
aerobic warm-up  
Prone trunk lift to neutral 
Spine mobilization on roller 
Quadruped arm/leg lift 
Standing shoulder 
flexion/thoracic extension  
Stretch/cool-down  
Bilateral latissimus pull-
down on roller 
Quadruped thoracic extension 
mobilization 
Neck and upper 
extremity  
Stretches 
Sidelying rotation and 
extension 
Spinal alignment  
Transversus abdominus 
Training in bilateral and single 
Lower extremity 

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strengthening  
leg stance 
stretches 
Wall push-ups with spine in 
neutral 
Training sit-to stand, squats, 
lunges 
Diaphragmatic 
breathing 
 
Control: Stretching exercises: To provide both the intervention group and the 
control group with equal opportunity to experience social support and to receive 
attention from a teacher, we have designed a control group that gives 
participants the same frequency and duration of group sessions as the 
intervention group. The control group exercises include non-kyphosis specific 
stretching exercise that is also included in the intervention. Sessions begin with 
aerobic warm-up on the treadmill or the bike at approximately 30-40% of their 
maximum, at a “fairly light” intensity, followed by stretching of all major muscle 
groups with a 20-30 second hold repeated 3-5 repetitions each, consistent with 
guidelines sufficient to increase flexibility.78, 84 Participants will be instructed to 
perform static stretching, without ballistic movements.  
 
Maintenance: After the 6-month exercise period, participants from both groups 
will continue their usual activity during the maintenance phase. They will 
receive a reminder phone call to wear the actigraph for a week88 each month to 
monitor physical activity during the maintenance phase. 
 
5.2 Handling of Study Interventions  
Standardization and quality control: Dr. Katzman will provide standardized training to the 
licensed physical therapists and physical therapy students involved in teaching the 
exercise sessions. Verbal instructions for the exercise intervention, verbal 
reinforcement, repetitions and progression in the exercise intervention have been 
standardized in our previous pilot study, and these procedures will be reviewed 
periodically to maintain consistency with the protocol. Throughout the study, Dr. 
Katzman will conduct unannounced drop in visits to the intervention and control group 
exercise and stretching classes to ensure ongoing consistent standardized 
implementation. To minimize other co-interventions, all participants will be asked to 
refrain from beginning any new recreational, exercise, or other treatments for kyphosis 
until the trial has ended. 
 
5.3 Adherence Assessment  
Study adherence will be monitored throughout the study.  Attendance at study 
visits and overall adherence to study protocol will be monitored.  
 
 

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6. STUDY PROCEDURES  
The study procedures are detailed in the Appendix. 
 
6.1 Schedule of Evaluations 
 
 
A participant’s eligibility will first be assessed with a telephone screening.  If person is 
still interested and eligible they will be asked to complete the following schedule of 
events: 
 Clinic Screening  
 Medical Screening  
 Run In  
 Testing Visit 1 (Baseline)  
 Intervention/Control Visits 
 Testing Visit 2 (6 month) 
 Maintenance Period  
 Testing Visit 3 (1 year) 
6.2 Description of Evaluations  
Telephone Screening:  When potential participants call inquiring about study, 
the research assistant will explain the study and obtain basic demographic 
information from the caller.  Callers will be screened for age, co-morbidities and 
if they think they have a curvature in their spine.    
 
Clinic Screening: After a participant is screened by telephone, they will be 
invited to attend a group orientation and, an individual screening visit will be 
scheduled. At this screening visit, Dr. Katzman and a research assistant will 
explain the study, obtain informed consent, and screen for additional criteria 
(kyphosis ≥40 degrees, active movement in the thoracic spine, gait speed ≥0.6 
meters/second and safety assessments).  
 
Medical Screening:  Once they meet initial screening criteria a study physician 
will review their medical criteria and contact their primary care provider before 
enrolling eligible participants in the study 
 
Run-in: Once enrolled in the study and prior to randomization, participants will 
be expected to attend a group orientation program at the study site where the 
exercise sessions will take place. Participants will receive an actigraph with 
verbal and written instructions to wear it at the waist or hip for 1 week to monitor 
physical activity. The purpose of this run-in period is to allow us to assess 
whether participants are committed to full participation in the study by 
documenting attendance and use of the actigraph.  
 
Test Visit 1 (Baseline and Randomization):   After the run-in period, participants 
will be randomized to the intervention group or control group. Participants will 

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be randomized in equal proportions to intervention or control using randomly 
permuted blocks of randomly selected size 4 stratified by age and gender. 
Treatment assignments will be generated prior to the study, then placed in 
order in sealed, opaque envelopes with stratum-specific sequential ID numbers. 
Consenting participants fulfilling study eligibility criteria will be assigned the next 
available ID number for the appropriate gender and age stratum. The date and 
time each envelope is opened will be recorded in a log along with participant ID 
to ensure integrity of randomization.  Participants in this study cannot be 
blinded, but study staff involved in measuring all outcome measures will not be 
involved in study visits or the study intervention, and will be blinded to group 
allocation. 
 
Participants will come in to the UCSF Clinical Research Center study site for 
kyphosis-related impairment, functional performance and health related quality 
of life measurements.  They will receive spinal radiographs and computed 
tomography scans at the UCSF Department of Radiology.  
 
Intervention/Control Study Visits: Participants assigned to the intervention 
group will receive a kyphosis-specific spinal strengthening group exercise 
program for 1 hour three times per week for 6 months, followed by 6 months of 
usual activity. The participants assigned to the control group will receive a non-
specific stretching group program for 1 hour three times per week for 6 months, 
followed by 6 months of usual activity. The intervention and the control group 
sessions will be conducted at one of the intervention study sites, including the 
UCSF PhysFit Physical Therapy Health and Wellness Center at the Mission 
Bay campus, Kasier Permanente French campus (pending), VA Medical Center 
(pending) and the Osher Center for Integrative Medicine (pending). A licensed 
physical therapist will teach the kyphosis-specific strengthening exercise 
intervention and a different physical therapist will teach the stretching 
intervention. Physical therapy students and/or research assistants will help 
ensure the safety of all participants and maintain a ratio of no more than 5 
participants to 1 teacher. 
 
Test Visit 2 (6 month): Participants will come in to the UCSF Clinical Research 
Center study site for kyphosis-related impairment, functional performance and 
health related quality of life measurements. They will receive spinal radiographs 
and computed tomography scans at the UCSF Department of Radiology.  
 
Maintenance Period: At the end of 6 months, participants will continue usual 
activity during the maintenance period.  Participants will receive phone calls to 
wear the step-counter for a week each month to monitor physical activity during 
the maintenance period.   
 
Test Visit 3 (1 year): At the end of one year, participants will be re-measured at 
the UCSF Clinical Research Center study site for kyphosis-related impairment, 
functional performance and health related quality of life measurements. They 
will receive spinal radiographs only at the UCSF Department of Radiology.  

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7. SAFETY ASSESSMENTS  
 
7.1 Specification of Safety Parameters 
A Data Safety and Monitoring Board has been created to review study safety 
and any adverse events that may occur.  The study research assistants will 
monitor participants during study visits and teach participants to self-monitor to 
prevent injury during testing and exercise sessions.  Prior to each visit, 
participants will complete an adverse event log to monitor pain, falls, and any 
injuries.  These will be reviewed daily by the PI and the Data Safety Monitoring 
Board has been established to review any adverse events.   
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
 
The Principal Investigator will review the safety and progress of this study on an 
ongoing basis. The PI will review the adverse event logs on a daily basis and is 
responsible for evaluating each AE as it occurs. In addition, results of safety 
reviews will be summarized in the annual progress reports submitted to the IRB 
and NIH. The annual report will include a list of all adverse events. The annual 
report will also address: (1) whether adverse event rates are consistent with pre-
study assumptions; (2) reason for dropouts from the study; (3) whether all 
participants met entry criteria; (4) whether continuation of the study is justified on 
the basis that additional data are needed to accomplish the stated aims of the 
study; and (5) conditions whereby the study might be terminated prematurely. 
Members of the study team will meet after each wave of the intervention to review 
the progress of the study and address any human subject issues that occur. These 
discussions may involve adverse event prevention measures, subject accrual 
issues, research staff training on protection of human subjects, as well as 
occurrence of adverse events. 
The Data Safety and Monitoring Board will meet two times a year.    
7.3 Adverse Events and Serious Adverse Events  
 
Description of Adverse Event Grading and Anticipated Adverse Events: An 
adverse event (AE) is here defined as any unfavorable and unintended sign, 
symptom, injury or disease temporarily associated with an intervention or 
procedure, regardless of whether it is considered related to an intervention or 
procedure that occurs during the course of the study. An AE may be unrelated 
to the experimental intervention, but nevertheless related to study participation. 

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The PI will assess the cause of the AE to determine whether it is definitely 
related, probably related, possibly related or unrelated to study participation. 
However, information about AE determined to be unrelated to the study 
participation must be retained for follow-up, documentation and reference.  In 
this study, we do not anticipate moderate, severe, life-threatening or fatal AEs. 
AE will be scored as follows: 
 
 
 
Grade 1   
Mild 
 
Transient of mild discomfort; no limitation in activity;  
 
no medical intervention or therapy required. 
 
 
 
Grade 2  
Moderate  
Mild to moderate limitation in activity – some  
 
assistance may be needed; simple therapeutic  
 
intervention/therapy may be required.  
 
 
 
Grade 3  
Severe  
Results in inability to carry on normal activities and  
 
required professional medical attention,  
 
hospitalization possible. 
 
 
 
Grade 4  
Life-   
Extreme limitation in activity, significant assistance
 
 
 
 
 
threatening required, results in an immediate risk of death 
and/or  
 
 
 
 
 
results in persistent or Significant disability. 
 
 
7.4 Reporting Procedures 
 
Reporting of Adverse Events (AE): The PI will review the adverse event logs on 
a daily basis and is responsible for evaluating each AE as it occurs. Dr. 
Katzman will notify the chair of the project’s DSMB and the UCSF Committee 
on Human Research (CHR) Institutional Review Board of the occurrence of any 
adverse events within 48 hours.  Serious adverse events (Death, Grades 3 and 
4) that occur during the course of the study will be reported immediately to the 
CHR Institutional Review Board at the University of California at San Francisco 
(UCSF) in accordance with current University guidelines for reporting adverse 
events, and the DSMB and NIH Program Administrator within 48 hours. 
 
7.5 Follow-up for Adverse Events 
Participants are informed to tell the study investigator, Wendy Katzman, PT, DPTSc, if 
they feel they have been injured because of taking part in the study. If they are injured 

Study of Hyerkyphosis, Exercise and Function 
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as a result of being in the study, the University of California will provide necessary 
medical treatment.  The costs of the treatment may be billed to the particpant or their 
insurer just like any other medical costs, or covered by the University of California or 
the study sponsor the National Institute of Aging, depending on a number of factors.  
The PI and the study physician will consult to determine if and when an injured 
participant may return to the study.  
7.6 Safety Monitoring  
The DSMB will make decisions based on pre-specified guidelines detailed below.  
Decision-making will explicitly include consideration of both statistical and non-
statistical issues. 
 
Subjects will have an opportunity to privately discuss any musculoskeletal or other 
physical complaints due to study exercise with a member of the research study staff 
on a weekly basis at the beginning of an exercise session. Participants will also have a 
contact number to report any potential adverse events that occur in between 
scheduled study visits. We will monitor participants during the study visits, and teach 
participants to self-monitor during study visits to prevent injury during the testing or 
exercise sessions. All participants will complete an adverse event log, including pain 
scale, falls and any injuries before each study visit. Dr. Katzman will be responsible for 
monitoring the study for patient safety and adverse events, and reviewing these logs 
on a daily basis. The DSMB will meet twice a year to review study progress and 
adverse events. 
 
8. INTERVENTION DISCONTINUATION  
 
Steps Emanating from Data Review  
The review of data may result in early termination of the study (see stopping guidelines 
section below), in protocol amendment, or in changes to the data collection plan or 
study forms. Should the protocol be amended as a result of data review, the UCSF 
CHR will be notified and the amendment approved prior to study amendment 
implementation unless the protocol amendment must be implemented to protect the 
immediate safety of the study subjects. In such a case, the protocol amendment will be 
immediately implemented and the UCSF CHR will be notified directly after protocol 
amendment implementation.  
 
Stopping Guidelines  
Stopping Early for Efficacy.  Improvements of physical activity are known to be difficult 
to maintain, so estimates of the durability of the effect, to be obtained at 1 year, will be 
important. In addition, the sedentary lifestyle this intervention addresses poses little 
risk of adverse events over the planned duration of the study. Accordingly, the slight 
delay in publishing results will be outweighed by the value of the information obtained 
from the longer term follow-up.  
 

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Stopping Early for Futility:  To avoid wasting resources, it is important to allow for early 
stopping because the likelihood of finding convincing evidence for a treatment benefit 
appears too low, in the light of interim results, to justify continuation of the trial. 
Accordingly, futility analyses will be conducted at the time of each interim efficacy 
analysis. So-called stochastic curtailment procedures [Lan KKG, Simon R, Halperin M. 
Stochastically curtailed tests in long-term clinical trials. Comm Statist, Series C 
(Sequential Analysis). 1982;1:207-219.  Halperin M, Lan KKG, Ware JH, Johnson WJ, 
DeMets DL. An aid to data monitoring in long-term clinical trials. Controlled Clin Trials. 
1982;3:311-323] will allow early stopping for futility if the conditional power to detect a 
beneficial effect is too low, given the data in hand. This lack of power should hold 
under plausible alternative hypotheses for the effect of treatment, including the effect 
assumed in determining the original sample size.  Note that this procedure involves no 
inflation of the type-I error rate, in fact inducing slight conservatism.  The DSMB would 
make the complex decision to stop early for futility in the light of the conditional power 
estimates, informed opinion about the plausibility of the alternatives considered, and 
other, broader considerations listed below.  
 
Stopping Early for Harm:  Because it would be unethical to require the same degree of 
certainty in repeated testing for a detrimental treatment effect as in repeated testing for 
benefit, protection of the type-I error rate becomes less important, and maintenance of 
power more pressing.  Moreover, adverse effects on secondary endpoints must be 
considered, thus involving multiple endpoints as well as multiple looks.  In view of 
these ethical and statistical complexities, stopping for harm will be done at the 
judgment of the DSMB, taking account of the seriousness and estimated excess risk of 
any observed adverse effects, the strength of the statistical evidence for them, and the 
broader guidelines listed below.  In addition to considering each adverse event 
individually, the DSMB will consider all the data together, and any necessary 
additional analyses to be carried out by the data coordinating center, before making a 
recommendation that the trial be modified or stopped.  
 
Reporting Temporary or Permanent Suspension of a Funded Clinical Trial  
 
The Principal Investigator will be responsible for immediately reporting to the National 
Institute of Aging (i.e., the Program Officer responsible for the grant), any temporary or 
permanent suspension of the project and the reason for the suspension. 
 
9. STATISTICAL CONSIDERATIONS  
9.1 General Design Issues 
 
Overview:   The primary analyses will be by treatment assignment, without 
regard to adherence to the intervention. Improvements in kyphosis, the Modified 
Physical Performance Test (PPT), and gait speed at 6 months will be co-primary 
endpoints.  The Hochberg procedure108 will be used in testing the effect of treatment 
on these three endpoints. However, given fiscal and feasibility limitations on this 

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single-site study, tests of treatment effects on 5 additional physical function and 
HRQOL measures (Aim 2), as well as muscle strength and density (Aim 3), and all 9 
comparisons at 1 year, will be regarded as secondary and analyzed without penalty for 
multiple comparisons, but with results clearly presented as hypothesis-generating. 
In preliminary analysis, we will use t-, Wilcoxon, chi-square, and Fisher exact tests as 
appropriate to compare the treatment and control groups in terms of baseline age, 
gender, co-morbidities, vertebral fractures, physical activity and level of kyphosis. If 
between-group imbalances are found, sensitivity analyses will be conducted adjusting 
for the imbalanced covariates.  However, the primary analysis will be unadjusted, to 
avoid inflation of type-I error and erosion of confidence due to model selection.  
9.2   Sample Size and Randomization 
Sample size calculation: We calculated minimal detectable effects (MDE) with 
80% power in 2-sided tests with a Bonferroni-corrected type-I error rate of 5%, 
in a sample of 100, allowing for within-subject correlation of the baseline and 6-
month outcomes, and loss to follow-up of 20% of participants. This trial is 
powered to detect a difference in change in kyphosis over 6 months of 2.2 
degrees (or more) between the intervention and control groups. Although the 
expected improvement in kyphosis is small, the hypothesis underlying this 
study is that preventing the expected progression of kyphosis,109 and improving 
kyphosis even a small amount, in combination with improvements in strength 
and conditioning, will result in meaningful improvements in physical function. In 
addition, the MDE for PPT and gait speed are comparable to clinically 
meaningful changes defined by Perera.110 Moreover, the MDE for kyphosis, 
PPT and gait are plausible in view of our uncontrolled pilot study results 
showing mean improvement of 6 degrees in kyphosis, 2 points in PPT and 0.05 
m/s in gait speed over 3 months. Even if regression to the mean and 
spontaneous improvement account for almost half of the mean improvement in 
our pilot study, our 6 month intervention is likely to yield benefits larger than the 
MDE in our trial. Standard methods for ANCOVA, positing reductions in residual 
variance by a factor of 1-r2 due to adjustment for the baseline value of the 
outcome, were used to obtain these estimates; here r is the within-subject 
correlation.  We used data from the pilot study to estimate r as 0.8 for kyphosis 
and PPT, and 0.85 for gait speed; we also used pilot data to obtain residual SD 
(5, 2.6, and .18 respectively). 
 
9.2.1  Treatment Assignment Procedures 
 Randomization: After the run-in period, participants will be randomized to the 
intervention group or control group. Participants will be randomized in equal 
proportions to intervention or control using randomly permuted blocks of 
randomly selected size 4 stratified by age and gender. Treatment assignments 
will be generated prior to the study, then placed in order in sealed, opaque 

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envelopes with stratum-specific sequential ID numbers. Consenting participants 
fulfilling study eligibility criteria will be assigned the next available ID number for 
the appropriate gender and age stratum. The date and time each envelope is 
opened will be recorded in a log along with participant ID to ensure integrity of 
randomization 
 
9.3 Interim analyses and Stopping Rules  
Monitoring Recruitment and Retention 
 
The adequacy of recruitment and retention will be assessed by the DSMB to ensure that the 
trial can meet research objectives. 
 
1. The recruitment goal is to enroll 20 eligible participants within a 3-month recruitment 
period. Enrollment lagging more than 4-weeks behind these goals will be of concern, 
and may trigger added evaluation, effort and approaches to recruitment. Enrollment 
lagging more than 8-weeks behind these goals will be of major concern, and may 
trigger changes in enrollment criteria or other aspects of the trial protocol.  
 
2. Retention of participants in the trial will depend on participant attending study visits 
and follow-up testing visits. The goal is to have 75% compliance with the 72 study 
visits and retain at least 75% of enrolled participants for all three testing visits. Loss to 
follow-up of more than 25% of participants will be reason for concern, and loss of more 
than 50% may trigger changes in enrollment criteria, changes in the protocol or 
termination of the trial.  
 
Supplementary Analyses:  Interim analyses will also be conducted of the effects of 
treatment group assignment on outcomes after regression adjustment for any 
important prognostic baseline characteristics sufficiently maldistributed between study 
groups to potentially confound the treatment effect estimate.  In addition, interim 
subgroup analyses will be used to help identify individuals more likely to benefit from, 
or to be harmed by, the treatment.  Pre-randomization characteristics will be used to 
define these subgroups, including ejection fraction, use of percutaneous coronary 
intervention at the time of the index myocardial infarction, and other factors that might 
be associated with efficacy.  Tests for interactions between treatment and subgroup 
could be particularly useful in identifying subgroups experiencing differential treatment 
effects10.  These exploratory analyses are important for assuring the safety of trial 
participants, and they will also be used, with appropriate caution, for generating 
hypotheses for subsequent testing. 
 
Additional Considerations in Interpreting the Data:  In addition to the statistical 
procedures described above, other considerations will be taken into account in 
interpreting interim results.  It is important for these additional considerations to be 
stated in advance to assure both study participants and investigators, who are masked 
to the data, that the DSMB will carefully consider many issues related to safety and 
efficacy and will recommend protocol changes or study termination if warranted.  Two 
important additional considerations will be (1) the consistency of the observed 

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differences between treatment groups in variables that should be associated with one 
another, and (2) the importance of these differences to the health and the safety of 
individuals in the trial.  Any differences between treatment groups in either outcome 
variables or adverse events will be considered for both their statistical significance and 
clinical importance.  These considerations for interpretation of data require the 
combined expertise of clinical and statistical experts. A number of specific 
considerations for interpretation of these data can be stated in advance: 
 
 Whether the magnitude or character of an observed difference constitutes a 
clinically important benefit or risk; 
 Whether the risk under consideration is outweighed by assessment of the 
overall potential benefit of therapy; 
 Whether the results could be explained by possible differences in baseline 
variables between the groups; 
 Whether results could be due to ascertainment bias caused by differences in 
treatment regimens; 
 Whether the results are consistent with those for other variables that should be 
associated with the variable in question; 
 Whether the results are consistent among various subgroups of participants 
and across the various centers involved in the study; 
 Whether it is likely that the current trends in the data could be reversed if the 
trial were to be continued unmodified; 
 The degree of additional precision or certainty in the results that could be 
obtained by continuing the trial; and, 
 Whether there would be significant loss in external validity or credibility of the 
trial by a change in Protocol or discontinuation. 
 
In summary, a recommendation to modify or discontinue the trial would not be based 
solely on statistical grounds.  Rather the DSMB supports the view voiced by Canner, 
on behalf of the Coronary Drug Project [Coronary Drug Project Research Group. 
Practical aspects of decision making in clinical trials: The Coronary Drug Project as a 
case study. Controlled Clin Trials. 1981;1(363-76)], that in clinical trial decision-making 
“No single statistical decision rule or procedure can take the place of the well reasoned 
consideration of all aspects of the data by a group of concerned, competent and 
experienced persons with a wide range of scientific backgrounds and points of view.” 
 
9.4 Outcomes  
Baseline characteristics and outcome measures proposed in this study (Table 3) will 
be collected at baseline and after the 6-month intervention. All outcome measures 
except computed tomography will be repeated at 1-year after the intervention.  
 
 
 
 

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Table 3. Baseline Characteristics and Outcome Measures at Study Visits 
 
Category 
  Variables: measure 
Baseline 
Testing 
6-month 
Testing 
1-year 
Testing 
Demographics – age, gender, ethnicity, education 
X 
 
 
Aging-related musculoskeletal impairments 
 
 
 
-      Bone density: hip BMD (DXA) 
X 
 
 
-      Vertebral fractures: lateral spine radiograph 
X 
 
 
-      Physical activity level: activity counts derived from Actigraph 
accelerometer 
X 
X 
X 
Kyphosis-related impairments 
 
 
 
-      Kyphosis: Cobb angle of kyphosis derived from lateral spine 
radiographs 
X 
X 
X 
-      Kyphosis: Kyphosis derived from Debrunner kyphometer 
X 
X 
X 
-      Spinal extensor muscle strength: Biodex computerized 
dynamometer 
X 
X 
X 
-      Spinal muscle density: spinal extensor muscle attenuation 
from CT scans (HU) 
X 
X 
 
Functional performance 
 
 
 
-      Composite physical function: Modified Physical 
Performance Test 
X 
X 
X 
-      Gait speed: 4-meter  
X 
X 
X 
-      Mobility: Timed Up and Go test 
X 
X 
X 
-      Spine endurance: Timed Loaded Standing 
X 
X 
X 
- 
Aerobic capacity/endurance: Six Minute Walk Test 
X 
X 
X 
Health-Related Quality of Life 
 
 
 
- 
Spine-specific health-related quality of life: SRS-30 
X 
X 
X 
- 
General health related quality of life: PROMIS Global 
Health 
X 
X 
X 
- 
Physical function related quality of life: PROMIS Physical 
function short form 
X 
X 
X 
 
9.4.1 Primary outcome variables 
Kyphosis: Kyphosis will be measured using the gold standard Cobb angle of kyphosis 
derived from standing lateral spine radiographs using a standardized protocol for 
thoracic kyphosis (T4-T12).28 The intraclass correlation coefficient (ICC) for repeated 
observer analysis of Cobb angle from the same radiograph is 0.99 and for single 
measurements taken from repeated radiographs is 0.82.28 When these estimates are 
combined, the ICC for radiographic measures of Cobb angle of kyphosis is 0.92, 
comparable to the ICC for kyphosis measurements using the Debrunner kyphometer 
0.95.89  
The Modified Physical Performance Test (PPT): This battery was developed as a 
composite measure of overall physical function in the aging adult.90, 91 The modified 
PPT includes 7-item timed standardized tasks: 50-foot floor walk, putting on and 
removing a lab coat, picking up and penny from the floor, standing up five times from a 
16-inch chair, lifting a 7-pound book to a shelf, climbing one flight of stairs, and 
standing with feet together and two additional untimed tasks: climbing up and down 

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four flights of stairs and performing a 360º turn. The score for each item ranges 
between 0 and 4, with 36 representing a perfect total score for the test. Test-retest 
reliability for the modified PPT score in community-dwelling older adult population is 
0.96.90 There is strong correlation with the Berg Balance Scale, r=0.7192 and low 
scores on the modified PPT predict physical frailty.92 
Gait speed: A 4-meter walk test will be used to measure gait speed. Slow gait speed 
has been shown in several different populations to be the single best predictor of 
functional decline and disability.74, 93, 94 The object of the 4-meter walk test is to 
determine the individual's speed while walking at their usual and fast pace. Test-retest 
reliability is 0.90,95 ICC for measures taken 2-weeks apart is 0.79.96 
9.4.2 Secondary outcome variables   
Timed Up and Go test (TUG): TUG is a widely used clinical tool for detecting mobility 
impairments in older adults. This test measures the time to rise from a 48 cm height 
armchair, walk 3 m, turn and return to a fully seated position in the chair.97 This test 
has excellent reliability (ICC 0.91-0.96) and sensitivity and specificity for identifying 
elderly individuals at risk for mobility impairments and falls.98, 99 
Timed Loading Standing: Timed Loading Standing is a test of combined trunk and arm 
endurance that measures the time a person can stand while standing a two-pound 
dumbbell in each hand with the arms at 90 degrees of shoulder flexion and the elbows 
extended.100 The ICC for same day inter-trial and 6 to10-day test retest reliability is 
0.89.100 Moderately high correlations were found between Timed Loaded Standing and 
16 measures of physical impairment and function.100 
Spinal extension muscle strength: We will use a standardized protocol for spine 
muscle extensor muscle strength using the Biodex 3 (Biodex Medical Systems Inc.) 
computerized dynamometer with the spine attachment to measures isometric peak 
torque to body weight ratio of spinal extension from semi-seated position.4 The ICC for 
1-week test retest reliability is 0.84 (95% CI=0.71, 0.96).4 
Spinal muscle density: Muscle density of the lumbar paraspinal muscles will be 
determined from calculations of fat infiltration into the paraspinal muscles at the L4-L5 
disc space from axial computed tomography (CT) images using proprietary software 
(RSI Systems, Boulder, CO). Measurement of fat infiltration from CT images has been 
validated in muscle biopsy studies.44 The coefficient of variation for reproducibility of 
spinal muscle density values among older adults is less than 5%.46 Dr. Thomas Lang 
developed the software, he will train our study staff to use the software and oversee 
quality control of the measurements.  
Six-minute Walk Test (SMWT): The SMWT is a widely used test of aerobic capacity; 
there are gender specific normative data available for community-dwelling older 
adults.101, 102 One week test retest reliability is 0.95 and compares with cycle 
ergometry r=0.58.101  
Additional outcomes 

Study of Hyerkyphosis, Exercise and Function 
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Health related quality of life (HRQOL): We will use the modified Scoliosis Research 
Society SRS-30 instrument,102 (self-image domain only), and the PROMIS Physical 
Function and Global Health questionnaires.  The pain and general self-image domain 
scores of the SRS-30 have significant correlation with Cobb angle of kyphosis in 
untreated scoliosis.104 Internal consistency, Cronbach's alpha, was 0.77 to 0.89 for all 
domains; validity of the modified SRS-30, determined by Pearson correlation 
coefficients with comparable SF-36 domains, was 0.70 for 13 of 14 relevant 
domains.102 
Other study measures: We will measure height and weight using standard methods, 
and collect a history of falls and current medications from detailed questionnaires. 
Bone density of the spine and hip will be measured using Dual X-ray Absorptiometry 
(DXA) and vertebral fractures will be adjudicated from T4 to L4 with lateral spine 
radiographs at baseline. Participants will complete a numeric rating pain scale,105 and 
adverse event log before participating in each exercise class. Physical activity will be 
measured with actigraphy.88, 106, 107 
9.5 Data Analyses  
  
Analysis for Specific Aim 1: Analysis of covariance (ANCOVA) will be used to assess 
the effects of intervention on changes in measured kyphosis and PTT scores from 
baseline to the end of the 6 month intervention period, adjusting for the baseline levels 
of each outcome, as well as for wave of recruitment. Normality and equality of 
variance of the residuals will be checked.  
Analysis for Specific Aim 2: We will also use analysis of covariance (ANCOVA) to 
assess the effect of intervention on changes from baseline to the end of the 6 month 
intervention period, in measured HRQoL, as measured by the spinal deformity specific 
SRS-30 and SF-36 health status instruments, and on secondary measures of physical 
function including gait speed, spinal extensor muscle strength, Timed Loaded 
Standing, and the Jug Test. The models will adjust for the baseline level of the 
outcome. 
Analysis for Specific Aim 3: The approach for Aims 1 and 2 will be used to assess 
intervention effects on muscle strength and density. We will then use structural 
equation modeling to assess the pathways through which the intervention affects 
physical function. We hypothesize that changes in kyphosis, strength and density 
mediate the effect of the intervention on change in physical function. These analyses 
will also control for mediation by increases in physical activity and aerobic capacity, as 
well as potential confounders of the changes in kyphosis and strength including age, 
and baseline kyphosis severity, physical activity level and vertebral fractures. Minimum 
detectable effects: The sample of 100 will provide 80% power to detect between-group 
differences of 6.2 points in spinal muscle strength, measured as a percentage of body 
weight, or 18% of the baseline mean of 35%. 
 
 

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10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
We will use the PROMIS Global Health and Physical Function questionnaires to 
collect study date.  The study instruments are below in the Supplement/ 
Appendices Section at the end.    
10.2 Data Management 
Overview of data management: Data will be entered/submitted by clinic staff 
and participants (where applicable) and tracked by project staff.  Authorized 
project/clinic staff may also update data to correct errors.  Data will be 
managed, queried, and secured by the UCSF Data Management Group (DMG), 
enabling simple real-time electronic data entry, timely identification and 
resolution of data discrepancies, and transforming data to SAS for viewing, 
reporting, and analyses. 
 
Data collection and editing:  data will be collected via web forms/surveys with 
REDCap® software and stored on mySQL/MS SQL databases.  Data collected 
will be viewed via the password-protected study website.  Every hour, pre-
programmed error-checking programs scan incoming forms for completeness 
and data ranges.   The results of the error-checking procedures are posted to 
the study web site, where study staff are notified to correct all errors. 
 
Data monitoring reports: Data are monitored on an ongoing basis by the Data 
Management Group to produce a number of standard reports that are made 
available on the study website automatically, including recruitment reports 
comparing goal versus actual recruitment rates; adherence reports comparing 
the number of expected visits to actual visits; and participant retention reports 
indicating the number of participants active, completed, and lost. 
 
Computer and data security: The UCSF Data Management Group network is 
privately maintained and hardware fire-walled, and none of the workstations or 
database servers can be directly addressed from outside the Local Area 
Network.  All study data will be stored on SQL servers that are backed-up 
nightly to disk and mirrored to a “failover” site at a co-location facility in San 
Francisco.  In addition, back-up copies of the entire enterprise are archived in 
Sacramento, CA by Recall, Inc.  All servers are housed in a state-of the-art 
secure server room with controlled access.  All servers are protected from 
viruses by Network Associates Netshield 4.x, Groupshield, and VirusScan 
Enterprise 7.x (McAfee, Santa Clara, CA.). 

Study of Hyerkyphosis, Exercise and Function 
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10.3 Quality Assurance  
10.3.1 Training 
Dr. Katzman will provide standardized training to the licensed physical 
therapists and physical therapy students involved in teaching the exercise 
sessions. Verbal instructions for the exercise intervention, verbal reinforcement, 
repetitions and progression in the exercise intervention have been standardized 
in our previous pilot study, and these procedures will be reviewed periodically to 
maintain consistency with the protocol.   
 
10.3.2 Monitoring 
After each wave of the intervention, the study staff will meet to review protocol 
compliance, recruitment and retention, adverse events forms, data quality, and review 
consent forms for completeness.   
 
Throughout the study, Dr. Katzman will conduct unannounced drop in visits to the 
intervention and control group exercise and stretching classes to ensure ongoing 
consistent standardized implementation. To minimize other co-interventions, all 
participants will be asked to refrain from beginning any new recreational, exercise, or 
other treatments for kyphosis until the trial has ended. 
 
Data quality will be assessed based on time to receipt of data and the proportions of 
missing, illogical and out of range variables. 
 
 
Measure 
Goal Value 
Acceptable Value 
 
• 
time to receipt of data 
<4 working days 
<10 working days 
 
• 
time to resolution of queries 
<2 working days 
<7 working days 
 
• 
missing variables 
     0 
        < 5% 
 
• 
variables queried* 
     5% 
        <10% 
 
*excluding Adverse Event and Medication Forms that are expected to have pending 
queries for current or ongoing items 
  
Every hour, pre-programmed error-checking programs scan incoming forms for 
completeness and data ranges.  The results of the error-checking procedures 
are posted to the study web site, where study staff are notified to correct all 
errors. 
 
   
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
 

Study of Hyerkyphosis, Exercise and Function 
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11.1 Institutional Review Board (IRB) Review  
  
This protocol and the informed consent document (Appendix II) and any 
subsequent modifications will be reviewed and approved by the IRB or ethics 
committee responsible for oversight of the study.  The consent form should be 
separate from the protocol document.  
 
 
11.2 Informed Consent Forms 
 
At the beginning of the screening visit, a member of the research staff will review the 
consent form in detail with the patient and answer all questions before inviting the 
patient to sign the consent form. A photocopy of the signed consent form with the 
Experimental Subjects' Bill of Rights is given to the patient.  Study personnel will 
review the content of the informed consent with each participant before they sign it. 
Participants will be asked to describe the benefits, risks and other options if they 
choose not to participate with the study personnel. 
 
11.3 Participant Confidentiality 
In order to maintain participant confidentiality, the study will ensure that (1) the 
informed consent process is conducted appropriately and that informed consent is 
obtained prior to proceeding with any study procedures; (2) data are collected and 
analyzed per protocol requirements; (3) the privacy and confidentiality of study 
subjects is maintained. Participation in research can involve loss of privacy; however, 
the participant’s names will not be included on questionnaires or other forms. It will be 
replaced by an identification number. 
The following precautions will be taken to maintain participant confidentiality: 
ºData are coded; data key is destroyed at end of study. 
ºData are coded; data key is kept separately and securely. 
ºData are kept in locked file cabinet. 
 
 
 
 
 
ºElectronic data are protected with a password. 
ºData are kept in locked office or suite. 
ºData are stored on a secure network. 
 
11.4 Study Discontinuation  
 
The study may be discontinued at any time by the UCSF Institutional Review 

Study of Hyerkyphosis, Exercise and Function 
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Board (IRB), the National Institute of Aging, or the data safety monitoring board 
(DSMB) as part of their duties to ensure that research participants are 
protected.  
 
12. COMMITTEES 
 
Data Safety Monitoring Board - DSMB 
 
 
13. PUBLICATION OF RESEARCH FINDINGS  
All publications of study findings will be reviewed by the NIA publications 
committee prior to submission. 
 
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adults: recommendation from the American College of Sports Medicine and the 
American Heart Association. Med Sci Sports Exerc. Aug 2007;39(8):1435-1445. 
79. 
Chodzko-Zajko WJPD, FACSM, (Co-Chair); Proctor, David N. Ph.D., FACSM, (Co-
Chair); Fiatarone Singh, Maria A. M.D.; Minson, Christopher T. Ph.D., FACSM; Nigg, 
Claudio R. Ph.D.; Salem, George J. Ph.D., FACSM; Skinner, James S. Ph.D., FACSM. 
American college of sports medicine position stand on exercise and physical activity for 
older adults 2009. 
80. 
Kok LY, Hamer PW, Bishop DJ. Enhancing muscular qualities in untrained women: 
linear versus undulating periodization. Med Sci Sports Exerc. Sep 2009;41(9):1797-
1807. 
81. 
Gearhart RF, Jr., Goss FL, Lagally KM, et al. Ratings of perceived exertion in active 
muscle during high-intensity and low-intensity resistance exercise. J Strength Cond 
Res. Feb 2002;16(1):87-91. 
82. 
Day ML, McGuigan MR, Brice G, Foster C. Monitoring exercise intensity during 
resistance training using the session RPE scale. J Strength Cond Res. May 
2004;18(2):353-358. 
83. 
Feigenbaum MS, Pollock ML. Strength training: rationale for current guidelines for 
adult fitness programs. Phys Sportsmed. Feb 1997;25(2):44-63. 
84. 
Pollock ML, Wenger NK. Physical Activity and Exercise Training in the Elderly: A 
Position Paper from the Society of Geriatric Cardiology. Am J Geriatr Cardiol. Jul 
1998;7(4):45-46. 
85. 
Patterson RM, Stegink Jansen CW, Hogan HA, Nassif MD. Material properties of 
Thera-Band Tubing. Phys Ther. Sep 2001;81(8):1437-1445. 
86. 
Bennell K, Wee E, Coburn S, et al. Efficacy of standardised manual therapy and home 
exercise programme for chronic rotator cuff disease: randomised placebo controlled 
trial. BMJ.340:c2756. 
87. 
Bautmans I, Van Arken J, Van Mackelenberg M, Mets T. Rehabilitation using manual 
mobilization for thoracic kyphosis in elderly postmenopausal patients with 
osteoporosis. J Rehabil Med. Feb 2010;42(2):129-135. 
88. 
Hart TL, Swartz AM, Cashin SE, Strath SJ. How many days of monitoring predict 
physical activity and sedentary behaviour in older adults? Int J Behav Nutr Phys Act. 
2011;8:62. 
89. 
Purser JL, Pieper CF, Duncan PW, et al. Reliability of physical performance tests in 
four different randomized clinical trials. Arch Phys Med Rehabil. May 1999;80(5):557-
561. 
90. 
Binder EF, Schechtman KB, Ehsani AA, et al. Effects of exercise training on frailty in 
community-dwelling older adults: results of a randomized, controlled trial. J Am 
Geriatr Soc. Dec 2002;50(12):1921-1928. 
91. 
Reuben DB, Siu AL. An objective measure of physical function of elderly outpatients. 
The Physical Performance Test. J Am Geriatr Soc. Oct 1990;38(10):1105-1112. 
92. 
Brown M, Sinacore DR, Binder EF, Kohrt WM. Physical and performance measures 
for the identification of mild to moderate frailty. J Gerontol A Biol Sci Med Sci. Jun 
2000;55(6):M350-355. 
93. 
Studenski S, Perera S, Wallace D, et al. Physical performance measures in the clinical 
setting. J Am Geriatr Soc. Mar 2003;51(3):314-322. 

Study of Hyerkyphosis, Exercise and Function 
-SHEAF  Protocol, Version 1.0 
 40 
94. 
Guralnik JM, Ferrucci L, Pieper CF, et al. Lower extremity function and subsequent 
disability: consistency across studies, predictive models, and value of gait speed alone 
compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 
Apr 2000;55(4):M221-231. 
95. 
Bohannon RW. Physical performance measures for the elderly rehabilitated at home. 
Int J Rehabil Res. Mar 1997;20(1):107-109. 
96. 
Jette AM, Jette DU, Ng J, Plotkin DJ, Bach MA. Are performance-based measures 
sufficiently reliable for use in multicenter trials? Musculoskeletal Impairment (MSI) 
Study Group. J Gerontol A Biol Sci Med Sci. Jan 1999;54(1):M3-6. 
97. 
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility 
for frail elderly persons. J Am Geriatr Soc. Feb 1991;39(2):142-148. 
98. 
Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in 
community-dwelling older adults using the Timed Up & Go Test. Phys Ther. Sep 
2000;80(9):896-903. 
99. 
Bischoff HA, Stahelin HB, Monsch AU, et al. Identifying a cut-off point for normal 
mobility: a comparison of the timed 'up and go' test in community-dwelling and 
institutionalised elderly women. Age Ageing. May 2003;32(3):315-320. 
100. 
Shipp KM, Purse JL, Gold DT, et al. Timed loaded standing: a measure of combined 
trunk and arm endurance suitable for people with vertebral osteoporosis. Osteoporos 
Int. 2000;11(11):914-922. 
101. 
Harada ND, Chiu V, Stewart AL. Mobility-related function in older adults: assessment 
with a 6-minute walk test. Arch Phys Med Rehabil. Jul 1999;80(7):837-841. 
102. 
Asher MA, Min Lai S, Burton DC. Further development and validation of the Scoliosis 
Research Society (SRS) outcomes instrument. Spine (Phila Pa 1976). Sep 15 
2000;25(18):2381-2386. 
103. 
Ware JE, Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. 
Conceptual framework and item selection. Med Care. Jun 1992;30(6):473-483. 
104. 
Watanabe K, Hasegawa K, Hirano T, Uchiyama S, Endo N. Use of the scoliosis 
research society outcomes instrument to evaluate patient outcome in untreated 
idiopathic scoliosis patients in Japan: part II: relation between spinal deformity and 
patient outcomes. Spine (Phila Pa 1976). May 15 2005;30(10):1202-1205. 
105. 
Hartrick CT, Kovan JP, Shapiro S. The numeric rating scale for clinical pain 
measurement: a ratio measure? Pain Pract. Dec 2003;3(4):310-316. 
106. 
Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and 
Applications, Inc. accelerometer. Med Sci Sports Exerc. May 1998;30(5):777-781. 
107. 
Matthews CE, Chen KY, Freedson PS, et al. Amount of time spent in sedentary 
behaviors in the United States, 2003-2004. Am J Epidemiol. Apr 1 2008;167(7):875-
881. 
108. 
Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. 
Biometrika. 1988;75:800-802. 
109. 
Kado D, Huang, MH, Karlamangla, AS, Cawthon, P, Katzman, W, Hillier, TA, Ensrud, 
K, Cummings, SR. Factors Associated With Kyphosis Progression in Older Women: 15 
years experience in the Study of Osteoporotic Fractures; 2011. 
110. 
Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and 
responsiveness in common physical performance measures in older adults. J Am 
Geriatr Soc. May 2006;54(5):743-749. 

Study of Hyerkyphosis, Exercise and Function 
-SHEAF  Protocol, Version 1.0 
 41 
111. 
Siminoski K, Warshawski RS, Jen H, Lee KC. The accuracy of clinical kyphosis 
examination for detection of thoracic vertebral fractures: comparison of direct and 
indirect kyphosis measures. J Musculoskelet Neuronal Interact. Sep 2011;11(3):249-
256. 
112. 
Roux C. [Non-invasive method for measuring bone mineral density]. Med Sci (Paris). 
Feb 2003;19(2):231-238. 
113. 
Njeh CF, Fuerst T, Hans D, Blake GM, Genant HK. Radiation exposure in bone 
mineral density assessment. Appl Radiat Isot. Jan 1999;50(1):215-236. 
 
 
 

Study of Hyerkyphosis, Exercise and Function 
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 42 
 
15. SUPPLEMENTS/APPENDICES 
I. PROCEDURES SCHEDULE 
 
Assessment 
Phone 
Screen  
Clinic 
Screen  
Medical 
Screen 
Run 
In 
Test  Visit 1 
(Baseline) 
Intervent
ion/ 
Control 
Visits  
(1-72) 
Test  Visit 
2     (6 
month) 
Mainten
ance      
Period 
Test  Visit 3        
(1year) 
Informed 
Consent Form   
 
 X 
 
  
  
  
  
  
  
Group 
Orientation 
(explain study) 
 
X 
 
X 
 
 
 
 
 
Basic 
Demographics 
X 
  
 
  
X  
  
  
  
 
DXA 
 
  
 
  
X  
  
  
  
 
Lateral Spine 
Radiograph 
 
 
 
 
X 
 
X 
 
X 
Medical 
History  
X 
  
X 
  
  
  
  
  
 
Screen (gait, 
kyphosis, 
safety 
assessment) 
 
X 
 
 
 
 
 
 
 
Current 
Medications 
X 
 
X 
 
 
 
 
 
 
Contact 
primary care 
providers for 
OK 
 
 
X 
 
 
 
 
 
 
Inclusion/ 
Exclusion 
Criteria  
X 
X 
 
X 
 
 
 
 
 
 
Enroll 
 
X 
 
 
 
 
 
 
 
Randomize 
 
 
 
 
X 
 
 
 
 
Intervention/ 
Control Study 
Visit 
 
 
 
 
 
X 
 
 
 
Kyphosis:  
Cobb angle of 
kyphosis 
 
 
 
 
X 
 
X 
 
X 
Kyphosis:  
Debrunner 
  
 
 
 
X 
 
X 
 
X 
Spinal muscle 
strength:  
Biodex 
computerized 
dynamometer 
  
 
 
 
X 
 
X 
 
X 

Study of Hyerkyphosis, Exercise and Function 
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Assessment 
Phone 
Screen  
Clinic 
Screen  
Medical 
Screen 
Run 
In 
Test  Visit 1 
(Baseline) 
Intervent
ion/ 
Control 
Visits  
(1-72) 
Test  Visit 
2     (6 
month) 
Mainten
ance      
Period 
Test  Visit 3        
(1year) 
Spinal muscle 
density:  CT 
scans 
 
 
 
 
X 
 
X 
 
 
Functional 
Performance 
  
 
 
 
X 
 
X 
 
X 
Health-
Related 
Quality of Life 
  
 
 
 
X 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study of Hyerkyphosis, Exercise and Function 
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II.  Informed Consent  Form 
 

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-SHEAF  Protocol, Version 1.0 
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-SHEAF  Protocol, Version 1.0 
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III. Other 
1.  PROMIS Global Health Questionnaire 
 
 

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-SHEAF  Protocol, Version 1.0 
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-SHEAF  Protocol, Version 1.0 
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2. 
  PROMIS Physical Function Questionnaire 

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3.  Scoliosis Patient Questionnaire 
 
 

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-SHEAF  Protocol, Version 1.0 
 
57 

 
Has the participant had any Adverse Events during this study?  
Yes     
 No    (If yes, please list all Adverse Events below) 
 
4. Adverse Event (AE) Report Form  
STUDY NAME:   
Site Number: 
 
Pt_ID: 
 
______________________ 
 
 
______________________ 
 
 
 
      
 
Severity 
Study Intervention 
Relationship 
Action Taken Regarding Study 
Intervention 
Outcome of AE 
Expected 
Serious 
1 = Mild 
2 = Moderate 
3 = Severe 
 
1 = Definitely related 
2 = Possibly related   
3 = Not related 
 
1 = None 
2 = Discontinued permanently 
3 = Discontinued temporarily 
4 = Reduced Dose 
5 = Increased Dose 
6 = Delayed Dose 
1 = Resolved, No Sequel 
2 = AE still present- no treatment 
3 = AE still present-being treated 
4 = Residual effects present-not                   
treated 
5 = Residual effects present- treated 
6 = Death 
7 = Unknown 
1 = Yes 
2 = No 
1 = Yes 
2 = No 
(If yes, 
complete SAE 
form) 
Adverse Event 
Start Date 
Stop Date 
Severity 
Relationship to 
Study Treatment 
Action 
Taken 
 
Outcome 
of AE 
Expected? 
Serious 
Adverse 
Event? 
Initials 
 
1. 
 
 
 
 
 
 
 
 
 
 
 
2. 
 
 
 
 
 
 
 
 
 
3. 
 
 
 
 
 
 
 
 
 

Study of Hyerkyphosis, Exercise and Function 
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1. 
SAE Onset Date:  _______________ (dd/mm/yyyy) 
2. 
SAE Stop Date: __________(dd/mm/yyyy) 
 
3. 
Location of serious adverse event: _________________________________ 
 
4. 
Was this an unexpected adverse event?        Yes 
       No  
 
 
5. 
Brief description of participant(s) with no personal identifiers:  
 
Sex:   F 
   M  
    Age: ______    
 
6. 
Brief description of the nature of the serious adverse event (attach description if more space needed): 
___________________________________________________________________ 
___________________________________________________________________ 
 
7. 
Category of the serious adverse event:   
 
 death – date __/___/___(dd/mmm/yyyy)  
 
 congenital anomaly / birth defect 
 life-threatening 
 
 
  
         
 
 required intervention to prevent 
 hospitalization-initial or prolonged   
 
 
permanent impairment 
 disability / incapacity 
 
  
  
 
 
 other:__________________ 
 
 
 
 
8. 
Intervention type:    
 Medication or Nutritional Supplement: specify___________ 
 Device: Specify: ________________________ 
 Surgery: Specify: ________________________ 
 Behavioral/Life Style: Specify: _____________________ 
 
5. Serious Adverse Event (SAE) Report Form  
 
                        Protocol Title: 
Protocol Number: 
Site Number:  
Pt_ID: 
 
______________________ 
 
______________________ 
 
______________________ 
 
 
    
 
 

Study of Hyerkyphosis, Exercise and Function 
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9. 
Relationship of event to intervention: 
 
  Unrelated (clearly not related to the intervention) 
  Possible (may be related to intervention) 
  Definite (clearly related to intervention) 
 
10. 
Was study intervention discontinued due to event?  
 Yes   
 No 
 
11. 
What medications or other steps were taken to treat serious adverse event?  
   
 
 
 
 
12. 
List any relevant tests, laboratory data, history, including preexisting medical conditions 
 
 
 
 
13. 
 Type of report: 
 
  Initial 
 
  Follow-up   
  Final 
 
 
Signature of Principal Investigator: _______________________ Date: _______ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Confidential
Page 1 of 5
Hyperkyphosis Telephone Screen
Please complete the survey below.
Thank you!
Participant ID:
__________________________________
Acrostic:
__________________________________
Interviewer:
__________________________________
How was person contacted:
Physician referral
Previous pilot
Recruitment letter
Flyer
Personal referral
Physician name:
__________________________________
Where did you see the flyer?
__________________________________
Subject Name: 
__________________________________
((Please spell))
Telephone:  home
__________________________________
cell phone number:
__________________________________
Are you 60 years of age or older?
Yes
No
Can you comfortably communicate in English with
Yes
verbal and written communication?
No
Have you or a family member or friend noticed that
Yes
you do not stand as straight and tall as you used to?
No
Are you able to walk inside without a cane or walker? 
Yes
No
Are you able to walk Â¼ block without using a cane or
Yes
a walker? 
No
Are you able to climb one flight of stairs
Yes
independently - without assistance from another
No
person?
Are you able to rise from a chair with your arms
Yes
crossed at your chest?
No
Are you able to straighten your upper back?
Yes
No
Do you have any chronic medical conditions such as:
A painful fracture of your vertebra (spine) in the
Yes
past 3 months? 
No
Total hip or knee replacement, or hip fracture in
Yes
past 6 mos.
No
Oral glucocorticoid medications (steroids) >=3 months
Yes
in the past year 
No

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Confidential
Page 2 of 5
Uncontrolled hypertension, chest pain, myocardial
Yes
infarct within past 6 months) 
No
Peripheral neuropathy in your arms or legs
Yes
No
Diagnosed vestibular or neurologic disorder
Yes
No
Unexplained weight loss (>10 pounds in the past year)
Yes
No
Have you fallen 3 or more times in the past year? 
Yes
No
Do you have any chronic medical conditions that could
Yes
prevent you from participating in an exercise program?
No
Have you been advised by a physician not to exercise? 
Yes
No
Do you already engage in regular (at least 3
Yes
days/week) vigorous (at least 30 continuous minutes)
No
exercise that includes spine strengthening exercise?
Do you have a current major uncontrolled psychiatric
Yes
illness, cognitive impairment or substance abuse? 
No
Do you have plans to move out of the area within the
Yes
next 6 months?
No
Are you interested in participating in a study that
Yes
meets three times a week for 6 months for one hour of
No
group exercise? 
Are you interested in participating in a study that
Yes
meets twice a week for 3 months for one hour of group
No
exercise? 
Which location would you prefer to attend the
Osher Center on Divisadero and Post Street?
exercise classes (check all that apply):
UCSF Department of Physical Therapy and
Rehabilitation Health and Wellness Center at
Mission Bay?
Kaiser Permanente - French Campus on Geary and 4th
Ave.
SF VA Medical Center on Clement and 25th Ave.
Do you have a friend or partner you want to be in the
Yes
study with?
No
Who is this person?
__________________________________
What is your address? 
__________________________________
City:
__________________________________

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Confidential
Page 3 of 5
State:
AL
AK
AZ
AR
CA
CO
CT
DE
FL
GA
HI
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
NE
NV
NH
NJ
NM
NY
NC
ND
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VT
VA
WA
WV
WI
WY
Zip code
__________________________________
What is the best phone number to reach you at?
__________________________________
What is your date of birth? 
__________________________________
What is the name of an emergency contact for you?
__________________________________
What is the phone number of an emergency contact for
__________________________________
you?
Do we have permission to contact your provider about
Yes
your participation in the study?   if no, advise
No
this is required for study participation
Name of primary physician, nurse practitioner or
__________________________________
physician's assistant:

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Confidential
Page 4 of 5
Address:
__________________________________
City:
__________________________________
State:
AL
AK
AZ
AR
CA
CO
CT
DE
FL
GA
HI
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
NE
NV
NH
NJ
NM
NY
NC
ND
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VT
VA
WA
WV
WI
WY
Zip code:
__________________________________
Phone number:
__________________________________
Are you available to come into UCSF Parnassus for a
Yes
clinical screening exam?
No
Provide them with a screening appointment
Why not?
Not interested in study
Other

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Page 5 of 5
Would you like to be contacted about future studies?
Yes
No
What is the best phone number to reach you at in the
__________________________________
future? 

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Confidential
Page 1 of 3
Hyperkyphosis Clinic Screening Exam
Please complete the survey below.
Thank you!
Participant ID
__________________________________
Acrostic
__________________________________
Interviewer
__________________________________
Was blood pressure measured?
Yes
No
Enter value: Systolic:
__________________________________
Diastolic:
__________________________________
Was Resting heart rate measured?
Yes
No
Enter value: Resting heart rate:
__________________________________
Gender
Male
Female
Age of menopause:
__________________________________
Current or prior hormone replacement 
Yes
No
Prior chronic glucocorticoid use (> 3 months in a row in the past year) 
Yes
No
Have you ever smoked cigarettes? 
Never
Yes

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Page 2 of 3
Current smoker 
Yes
No
Past smoker 
Yes
No
Do you currently drink alcohol (more than 1 drink a month)? 
Yes
No
Average number of drinks/week
__________________________________
History of fracture 
Yes
No
Where:
spine
hip
arm
leg
other
Biological parent fractured a hip?
Yes
No
Don't know
Biological parent had stooped posture?
Yes
No
Don't know
Which parent?
mother
father
Current or past osteoporosis medication use 
Yes
No
Don't know
current or prior use?
current
prior
Do you have chest pain on exertion? 
Yes
No
I don't know

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Confidential
Page 3 of 3
Shortness of breath on exertion
Yes
No
I don't know
Joint pain or arthritis
Yes
No
what joint?
shoulder
elbow
wrist/hand
neck
back
hip
knee
ankle
jaw

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Confidential
Page 1 of 12
Hyperkyphosis Medical History
Please complete the survey below.
Thank you!
Participant ID
__________________________________
Acrostic
__________________________________
Interviewer
__________________________________
Have you ever been diagnosed with any of the following conditions?
Heart attack
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Transient ischemic attack
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Stroke
Yes
No
Don't know
Year of diagnosis:
__________________________________

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Page 2 of 12
Are you currently under a physician's care for this? 
Yes
No
High blood pressure
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Peripheral vascular disease
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Diabetes
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Kidney disease
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No

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Page 3 of 12
Neuropathies (problems with sensation)
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Respiratory disease including asthma
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Parkinson's disease
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Multiple sclerosis
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Polio/post-polio syndrome
Yes
No
Don't know
Year of diagnosis:
__________________________________

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Page 4 of 12
Are you currently under a physician's care for this? 
Yes
No
Epilepsy/seizures
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Cancer
Yes
No
Don't know
what kind?
breast
prostate
bladder
colon/rectal
endometrial
kidney (renal cell)
leukemia
lung
melanoma
non-Hodgkin lymphoma
pancreatic
thyroid
other
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Osteoporosis
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Rheumatoid arthritis
Yes
No
Don't know
Year of diagnosis:
__________________________________

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Page 5 of 12
Are you currently under a physician's care for this? 
Yes
No
Osteoarthritis/joint pain
Yes
No
Don't know
where?
neck
back
shoulder
elbow
wrist/hand
hip
knee
foot/ankle
other
Osteoarthritis: neck:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: neck:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: neck:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No
Osteoarthritis: back:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)

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Page 6 of 12
Osteoarthritis: back:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: back:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No
Osteoarthritis: shoulder:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: shoulder:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: shoulder:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No
Osteoarthritis: elbow:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: elbow:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No

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Page 7 of 12
Osteoarthritis: elbow:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No
Osteoarthritis: wrist/hand:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: wrist/hand:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: wrist/hand:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No
Osteoarthritis: hip:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: hip:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: hip:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No

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Page 8 of 12
Osteoarthritis: knee:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: knee:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: knee:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No
Osteoarthritis: foot/ankle:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: foot/ankle:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: foot/ankle:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No

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Page 9 of 12
Osteoarthritis: other:
what is average level of pain
0 (none)
1
2
3
4
5
6
7
8
9
10 (worst imaginable pain)
Osteoarthritis: other:
does it interfere with basic activities of daily living (including dressing, eating, walking, toileting, hygiene) 
Yes
No
Osteoarthritis: other:
does in interfere with instrumental activities of daily living (including shopping, housekeeping, accounting, food
preparation, telephone/transportation)
Yes
No
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Degenerative disc disease
Yes
No
Don't know
where?
neck
back
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Joint  replacement surgery
Yes
No
Don't know

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Page 10 of 12
which joint?
shoulder
hip
knee
other
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Prior spine surgery
Yes
No
Don't know
what type?
spinal fusion
laminectomy
foramenotomy
other
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Scoliosis
Yes
No
Year of diagnosis
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Cerebellar problems (ataxia)
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No

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Page 11 of 12
Chemical dependency (alcohol or drugs)
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Depression
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Post traumatic stress disorder (PTSD)
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Latex allergy
Yes
No
Don't know
Year of diagnosis:
__________________________________
Are you currently under a physician's care for this? 
Yes
No
Was time to walk over 4 m course collected?
Yes
No
Time to walk over a 4 meter course: 
__________________________________
(seconds)

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Page 12 of 12
why not?
Participant refused
Participant unable
Was usual Kyphosis measured? 
Yes
No
record :
__________________________________
(degrees)
why not?
Participant refused
Participant unable
was Best kyphosis measured? 
Yes
No
record:
__________________________________
why not?
Participant refused
Participant unable
Difference between Best and usual kyphosis:
__________________________________
Sit to stand from 16" high chair (Able to perform with arms crossed over chest)
Yes
No
Safety tests:
Able to transition from standing to recumbent on the floor and rise from the floor to standing
Yes
No
Able to lift both arms to shoulder level
Yes
No
Able to stand with feet side by side for 30 seconds
Yes
No
Able to stand with feet hip-width apart for 60 seconds.
Yes
No

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Page 1 of 1
Hyperkyphosis Medications Inventory
Please complete the survey below.
Thank you!
Do you take medications, vitamins and supplements?
Yes
No
Medication allergy?
Yes
No
How many do you take?
1
2
3
4
5
6
7
8
9
10
Name:
__________________________________
Prescription:
Yes
No
Duration of use:
< 1 month
1 month - 1 year
1 - 3 years
3 - 5 years
> 5 years
Don't know
Frequency:
As needed
Regular

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Page 1 of 1
Hyperkyphosis Demographics
Please complete the survey below.
Thank you!
Participant ID
__________________________________
Acrostic
__________________________________
Interviewer
__________________________________
Date of birth
__________________________________
Sex
male
female
Ethnicity
Hispanic or Latino
Not Hispanic or Latino
Race (mark all that apply)
American Indian/Alaska Native
Asian
Native Hawaiian/Other Pacific Islander
Black or African American
White
Highest level of education 
Some high school or less
High school graduate or GED or equivalent
Some college, vocational school (or junior college)
College graduate (BA, BS)
Professional or graduate degree (MA, MS, MBA, PhD, MD, JD, etc.)

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Page 1 of 2
Hyperkyphosis Kyphosis and Strength Characteristics 
Please complete the survey below.
Thank you!
Participant ID
__________________________________
Acrostic
__________________________________
Interviewer
__________________________________
Height
__________________________________
(cms)
Weight
__________________________________
(kgs)
Cobb angle of kyphosis from kyphometer - usual1
__________________________________
(degrees)
Cobb angle of kyphosis from kyphometer - usual2
__________________________________
(degrees)
Difference between Usual 1 and Usual 2
__________________________________
(degrees)
Cobb angle of kyphosis from kyphometer - usual3
__________________________________
(degrees)
Lumbar lordosis from kyphometer - usual1
__________________________________
(degrees)
Lumbar lordosis from kyphometer  - usual2 
__________________________________
(degrees)
Difference between Usual 1 and Usual 2
__________________________________
(degrees)
Lumbar lordosis from kyphometer - usual3
__________________________________
(degrees)

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Mean lumbar lordosis from kyphometer 
__________________________________
Spinal extension total work from biodex at 60 deg/s
__________________________________
(newtons)
Spinal extension peak torque/body weight  from biodex at 60 deg/s 
__________________________________
(%)
Spinal extension coefficient of variation at 60 deg/s
__________________________________
(%)
Spinal flexion total work from biodex at 60 deg/s
__________________________________
(newtons)
Spinal flexion peak torque/body weight  from biodex at 60 deg/s
__________________________________
(%)
Spinal flexion coefficient of variation at 60 deg/s
__________________________________
(%)
Spinal extension total work from biodex at 90 deg/s
__________________________________
(newtons)
Spinal extension peak torque/body weight from biodex at 90 deg/s
__________________________________
(%)
Spinal extension coefficient of variation at 90 deg/s 
__________________________________
(%)
Spinal flexion total work from biodex at 90 deg/s
__________________________________
(newtons)
Spinal flexion peak torque/body weight from biodex at 90 deg/s 
__________________________________
(%)
Spinal flexion coefficient of variation at 90 deg/s
__________________________________
(%)

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Page 1 of 6
Hyperkyphosis Physical performance testing
Please complete the survey below.
Thank you!
Participant ID
__________________________________
Acrostic
__________________________________
Interviewer
__________________________________
Standing Static Balance
Were the balance tests completed? 
Yes
No
Side-by-side stand
Was participant able to hold side-by-side stand for 10 seconds?
Yes
No
Did the participant hold the side-by-side stand for more than 0 seconds?
Yes
No
Enter time: 
__________________________________
(seconds)
Why wasn't the side-by-side test completed?
participant unable to hold side-by-side stand for any time
participant refused side-by-side test
side-by side test not attempted or data missing
Semi-tandem stand
Was participant able to hold semi-tandem stand for 10 seconds?
Yes
No
Did the participant hold the semi-tandem stand for more than 0 seconds?
Yes
No
Enter time: 
__________________________________
(seconds)

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Why wasn't the semi-tandem test completed?
participant unable to hold semi-tandem stand for any time
participant refused semi-tandem test
semi-tandem test not attempted or data missing
Tandem stand
Was participant able to hold tandem stand for 10 seconds?
Yes
No
Did the participant hold the tandem stand for more than 0 seconds?
Yes
No
Enter time: 
__________________________________
(seconds)
Why wasn't the tandem test completed?
participant unable to hold tandem stand for any time
participant refused tandem test
tandem test not attempted or data missing
Chair Rise
Were the chair tests completed?
Yes
No
Was participant able to rise once without using arms?
Yes, did not use arms
No
Why wasn't participant able to rise once without arms?
Used arms to stand
Unable to rise once from chair even with arm use
Participant refused to rise from chair once
Rise from chair once not attempted or data missing
Was participant able to rise five times without using arms?
Yes
No
enter time to complete
__________________________________
(seconds)
Why wasn't participant able to rise five times without arms?
participant used arms to stand but completed 5 stands
unable to complete all 5 stands (regardless of arm use)
participant refused to rise from chair five times
rise from chair five times not attempted or data missing
Book lift

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Was participant able to complete the book lift task?
Yes
No
Enter time:
__________________________________
(seconds)
Why wasn't the book lift task completed?
Participant unable to do this task
Participant refused test
Test not attempted or data missing
Jacket task
Was participant able to complete the jacket on/off task?
Yes
No
Enter time:
__________________________________
(seconds)
Why wasn't the jacket on/off task completed? 
Participant unable to do this task
Participant refused test
Test not attempted or data missing
Pick up penny task
Was the participant able to complete the pick up a penny from floor task?
Yes
No
Enter time:
__________________________________
(seconds)
Why wasn't the pick up penny task completed? 
Participant unable to do this task
Participant refused test
Test not attempted or data missing
Turn 360 degrees task
Was the participant able to complete the turn 360 degrees task? 
Yes
No
Why wasn't the turn 360 degrees task completed? 
Participant unable to do this task
Participant refused test
Test not attempted or data missing

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Was number of steps taken in 360 degree task collected?
Yes
No
How many steps were taken in the turn 360 degree task? 
__________________________________
(steps)
Were the steps taken in the turn 360 degrees task discontinuous or continuous?
Discontinuous steps
Continuous  steps
Unable to assess steps
Was the gait in the turn 360 degrees task steady or unsteady?         
Unsteady (grabs, staggers)
Steady
Unable to assess gait
50-foot walk
Was the participant able to complete the50-foot walk from floor task?
Yes
No
Enter time: 
__________________________________
(seconds)
Why wasn't the 50-foot walk completed? 
Participant unable to do this task
Participant refused test
Test not attempted or data missing
4 meter walk
Was the 4 meter (13.1234 feet) task completed?
Yes
No
enter time to complete
__________________________________
(seconds)
Why wasn't the 4 meter task completed?
Participant unable to do this task
Participant refused test
Test not attempted or data missing
Stairs
Was the stairs task completed?
Yes
No

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Why wasn't the stairs completed?
Participant unable to do this task
Participant refused test
Test not attempted or data missing
Were number of flights climbed recorded:
Yes
No
How many flights of stairs were climbed? 
__________________________________
(flights)
Was blood pressure measured after the stairs task?
Yes
No
Enter diastolic:
__________________________________
Enter systolic:
__________________________________
Was heart rate measured after stairs task?
Yes
No
Enter heart rate:
__________________________________
(beats per 15 seconds)
Timed up and go
Was the timed up and go test completed?
Yes
No
enter time to complete 
__________________________________
(seconds)
Why wasn't the timed up and go test completed?
Participant unable to do this task
Participant refused test
Test not attempted or data missing
Timed loaded standing
Was the timed loaded standing test completed?
Yes
No
enter time to complete 
__________________________________
(seconds)

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Why wasn't the timed loaded standing test completed?
Participant unable to do this task
Participant refused test
Test not attempted or data missing
Six minute walk test
Was the six minute walk test completed?
Yes
No
enter total lengths completed
__________________________________
Feet in final lap 
__________________________________
(ft.)
Total distance covered (total lengths completed x 60) + feet in final lap) =
__________________________________
(ft.)
Total distance covered in meters:
note: I can round this down to a certain number of decimal places
__________________________________
(meters)
Why wasn't the six minute walk test completed?
Participant started unable to complete this task (could not walk for 6 minutes)
Participant unable to walk at all
Participant refused test
Test not attempted or data missing
Was the time that the participant walked recorded?
Yes
No
enter time: 
__________________________________
(minutes)
enter distance walked in that time:
__________________________________
(feet)

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Page 1 of 4
Hyperkyphosis Physical Activity Survey
Please complete the survey below.
Thank you!
Participant ID:
__________________________________
Acrostic:
__________________________________
Interviewer:
__________________________________
The next few questions ask about your physical activity during the last 7 days. If the last 7
days have not been typical because of illness or bad weather, please estimate based on two
or three weeks ago.
Over the past 7 days, how often did you participate in sitting activities such as reading, watching TV or doing
handcrafts?
Never
Seldom (1-2 days)
Sometimes (3-4 days)
Often (5-7 days)
What were these activities?
On average, how many hours per day did you engage in these sitting activities?
Less than 1 hour
Between 1 and 2 hours
2-4 hours
More than 4 hours
Over the past 7 days, how often did you take a walk outside your home or yard for any reason? For example, for fun or
exercise, walking to work, walking the dog, etc.?
Never
Seldom (1-2 days)
Sometimes (3-4 days)
Often (5-7 days)
What were these activities?

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On average, how many hours per day did you spend walking?
Less than 1 hour
Between 1 and 2 hours
2-4 hours
More than 4 hours
Over the past 7 days, how often did you engage in light sport or recreational activities such as bowling, golf with a cart,
shuffleboard, fishing from a boat or pier, or other similar activities?
Never
Seldom (1-2 days)
Sometimes (3-4 days)
Often (5-7 days)
What were these activities?
On average, how many hours per day did you engage in these light sport or recreational activities?
Less than 1 hour
Between 1 and 2 hours
2-4 hours
More than 4 hours
Over the past 7 days, how often did you engage in moderate sport and recreational activities such as doubles tennis,
ballroom dancing, hunting, ice skating, golf without a cart, softball or other similar activities?
Never
Seldom (1-2 days)
Sometimes (3-4 days)
Often (5-7 days)
What were these activities?
On average, how many hours per day did you engage in these moderate sport or recreational activities?
Less than 1 hour
Between 1 and 2 hours
2-4 hours
More than 4 hours
Over the past 7 days, how often did you engage in strenuous sport and recreational activities such as jogging,
swimming, cycling, singles tennis, aerobic exercise, skiing (downhill or cross country) or other similar activities?
Never
Seldom (1-2 days)
Sometimes (3-4 days)
Often (5-7 days)
What were these activities?

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Page 3 of 4
On average, how many hours per day did you engage in these strenuous sport or recreational activities?
Less than 1 hour
Between 1 and 2 hours
2-4 hours
More than 4 hours
Over the past 7 days, how often did you do any exercise specifically to increase muscle strength and endurance, such
as lifting weights or pushups, etc.?
Never
Seldom (1-2 days)
Sometimes (3-4 days)
Often (5-7 days)
What were these activities?
On average, how many hours per day did you engage in exercises to increase muscle strength and endurance?
Less than 1 hour
Between 1 and 2 hours
2-4 hours
More than 4 hours
During the past 7 days, have you done any light housework, such as dusting or washing dishes?
Yes
No
During the past 7 days, have you done any heavy housework or chores, such as vacuuming, scrubbing floors, washing
windows or carrying wood?
Yes
No
During the past 7 days, did you engage in any of the following activities? (Please
answer yes or no for each item.)
Home repairs, like painting, wallpapering, electrical work, etc.?
Yes
No
Lawn work or yard care, including snow or leaf removal, wood chopping, etc.?
Yes
No
Outdoor gardening?
Yes
No
Caring for another person, such as children, dependent spouse, or another adult?
Yes
No

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During the past 7 days did you work, either for pay or as a volunteer?
Yes
No
How many hours in the past week did you
work for pay and/or as a volunteer?
__________________________________
Which of the following categories best describes the amount of physical activity required on your job and/or volunteer
work?
Mainly sitting with slight arm movements - Examples: office worker, watchmaker, seated assembly line worker,
bus driver, etc.
Sitting or standing with some walking - Examples: cashier, general office worker, light tool and machinery
worker
Walking, with some handling of materials generally weighing less than 50 pounds - Examples: mailman,
waiter/waitress, construction worker, heavy tool and machinery worker
Walking and heavy manual work often requiring handling materials weighing more than 50 pounds - Examples:
lumberjack, stone mason, farm or general laborer.

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Page 1 of 3
Hyperkyphosis Weekly Log
Please complete the survey below.
Thank you!
Participant ID
__________________________________
Acrostic
__________________________________
Interviewer
__________________________________
Class number:
__________________________________
Wave number:
__________________________________
Have you fallen since the last group exercise class?
Yes
No
how many times: 
1
2
3 OR MORE
was it an injurious fall?
Yes
No
check all that apply
Muscle strain
Joint sprain
bruise
fracture
Other
Have you had any injuries not related to a fall since the last group exercise class?
Yes
No
please check all that apply
Muscle strain
Joint sprain
bruise
fracture
OTHER

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Page 2 of 3
Has your usual level of pain changed since the last class? 
Yes
No
Overall average pain level in the 48hours prior to assessment at rest
0 - No pain
1
2
3
4
5
6
7
8
9
10 - Worst pain imaginable
Describe location: (Mark all that apply):
arms R
arms L
legsR
legs L
shoulders R
shoulders L
backR
back L
neckR
neck L
head
other
other:
__________________________________
Overall average pain level in the 48hours prior to assessment during movement
0 - No pain
1
2
3
4
5
6
7
8
9
10 - Worst pain imaginable

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Describe location: (Mark all that apply):
arms R
arms L
legsR
legs L
shoulders R
shoulders L
backR
back L
neckR
neck L
head
other
other:
__________________________________