Physical Function in Older Adults in the Stay Strong, Stay Healthy Program
Phase: NA
Conditions: Frail Elderly, Sedentary Lifestyle
Sponsor: Dana Duren

IRB # 2014256 Page 1 of 6 
Project Title:   
Physical Function in Older Adults in the Stay Strong, Stay Healthy Program 
 
IRB Number:   
2014256 
Version Number:  
2.0 
Version Date:   
05.09.2019          IRB Approved 05.15.2019 
 
Principal Investigator: Dana Duren PhD 
Co-Investigators:  
Stephen Ball, PhD; Breanne Baker, PhD; Trent Guess, PhD 
Research Staff:  
Kristin Miller, MS; Kelsey Weitzel, MS; Stacee Clawson, BSN, RN, CCRP; Rebecca  
 
 
 
Shafer, MS; Elena Doctor BS 
 
Funding Source:  
Department of Nutrition and Exercise Physiology 
 
Clinical Trial Phase: II 
Clinicaltrials.gov Number: Pending 
 
Research Background and Objectives 
     The University of Missouri’s Stay Strong, Stay Healthy (SSSH) program is an eight week strength training 
class for older adults. SSSH is modeled after the evidence-based StrongWomen program developed by 
researchers at Friedman School of Nutrition Sciences at Tufts University1,2. While the original Tufts program 
included only women, University of Missouri Extension has adapted the curriculum to also include men. 
Strength training programs, like SSSH, can increase muscle mass and strength3, improve bone density and 
reduce the risk of osteoporosis and related fractures4, improve diabetes, heart disease, arthritis, depression, and 
obesity5; and increase self-confidence, sleep and vitality6 in older adults. Specifically, the SSSH program 
increases elderly individuals’ confidence in their physical strength and balance7. The present study will 
elucidate the effects of the SSSH program on specific measures of balance, muscle capacity, and skeletal health 
in a cohort of older adults from Central Missouri. 
 
     The primary objective of this research study is to track physiologic changes and determine the effectiveness 
of the SSSH exercise intervention in older adults. Participant’s balance, gait, muscle strength, body 
composition, and skeletal health will be compared to a walking group and to a sedentary control group prior to 
and immediately following the eight week exercise intervention. 
 
Participant centered objectives include: 
 Participants will improve their balance, thus reducing their risk for falls. 
 Participants will increase their muscle strength and improve body composition. 
 Participants will increase their rate of bone formation. 
 Participants will improve their cognition and sleep habits. 
 Participants will increase their physical activity 
Recruitment Process 
     The Stay Strong, Stay Healthy program is conducted throughout the state of Missouri. Class sessions are 
advertised by posting flyers and in newspapers. At the University of Missouri-Columbia, the SSSH program is 
advertised by posting flyers around campus and utilizing the email group for retired MU employees. Dr. Baker 
and research staff will also present the research study participation opportunity at pre SSSH sessions in 
Columbia and surrounding areas. We will be available to answer questions via email and phone for any 
potential participants prior to their first visit on campus. The inclusion and exclusion criteria listed below in 
addition to the PAR-Q form will make up the initial screening form. During the recruitment process research 
staff will use this form to quickly screen potential participants for overt exclusion criteria, thus reducing the 
number of “screen failure” participants who will have to coordinate travel to campus for the first consenting 
visit. No personal health information is contained in these forms and all questions are yes/no, and this data will 

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only be recorded for screening failures to inform selection bias. The inclusion of this form is purely the research 
team’s attempt to reduce patient burden as travel can be very difficult for this patient population. 
Inclusion/Exclusion Criteria 
Participants will be included in the study if they: 
 Are male or female ≥60 years of age 
 Are sedentary (no strength training and <30min/wk of other physical activity in the past 3 months) 
 Are ambulatory (cane or walker permitted) 
 Are free from current physical injury or illness preventing physical activity 
Participants will be excluded in the study if they: 
 Answered YES to two or more questions on the PAR-Q form  
 Are female subjects who have not fully gone through menopause 
 Were a previous SSSH participant 
 Have dementia/Alzheimer’s or other cognitive impairments that would limit ability to follow directions 
 
Consent Process    
  Only research staff cleared to obtain written consent will escort participants to a private room in Gwynn 
Hall, where all screening and consenting will take place. After participants have cleared the initial screening 
checklist (the PAR-Q form and inclusion/exclusion criteria), research staff will deliberately and clearly explain 
each aspect of the informed consent. Participants will be encouraged to ask questions and will be reminded of 
the voluntary nature of their participation prior to signing the informed consent form. Signed informed 
consents will be collected and securely stored in Dr. Duren’s office. At this time, participants will also be 
given an additional copy of the informed consent for future reference. 
Number of Subjects 
     Using G*Power (V3.1) sample size calculations were completed using estimated and calculated effect sizes 
from previously published SSSH research 7-9. Estimated low and medium effect sizes resulted in a sample size 
ranging from 12-55. Calculated effect sizes for the 30 second sit to stand (balance), DXA (body composition), 
and the Self Administered Gerocognitive Examination (cognitive function) resulted in a sample size ranging 
from 9 to 43. We believe nearly 50 participants total are needed to reach statistical power for this study; 
however, assuming 15% attrition rates, 60 participants (up to 20 per group) will be recruited for the study. 
 
Study Procedures/Design/Treatment Plan 
     Participants who chose to enroll will be required to provide approximately five hours of their time total, in 
addition to intervention exercise activities. The first visit will consist of the initial screening form and the 
informed consent, followed by a facility tour, and familiarization of the testing procedures and will take one 
hour. The second and third visits are identical in procedure and time required and will consist of a urine sample, 
blood draw, anthropometrics, DXA scans, and functional performance assessments, and questionnaires. These 
two visits lasting 2 hours each will occur immediately before and after the eight week intervention period. Each 
visit and all questionnaires and procedures are explained in greater detail below. This organizational timeline of 
study activities will also be made available for participants. 
 
 

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Visit I 
Location: The first visit will take place in the Exercise Physiology Laboratory in Gwynn Hall, subsequent tours 
of McKee Gymnasium may also occur. 
Duration: 1 hour 
     During the first visit to campus participants will go over the initial screening form which includes the 
Physical Activity Questionnaire (PAR-Q), a risk assessment for chronic disease characteristics that may 
increase risk of exercise injury, and the inclusion and exclusion criteria. If participants are cleared they will then 
be given the informed consent and allowed ample time to ask questions about the study requirements. All 
possible precautions will be taken to avoid inadvertent coercion in the recruitment process. The research team 
will stress that participation is completely voluntary and can be terminated at any time for any reason.  
     Once participants clear the initial screening process and sign the informed consent (a copy of the informed 
consent will be provided to the participant at this time), participants will be given a tour of the McKeee 
Gymnasium where they will become familiar with all testing procedures. Qualified subjects will be scheduled 
for Visit II. 
Visits II & III 
Location: The first part of these visits will take place in the Exercise Physiology Laboratory in Gwynn Hall, 
followed by function performance testing in McKee Gymnasium. 
Duration: 2 hours 
   The methods for Visit II and Visit III are identical and will occur the week prior to the SSSH intervention 
beginning and the week after the intervention is over. Both of these visits will include a urine sample, blood 
draw, and DXA scans followed by functional performance testing and questionnaires. Questionnaires include 
pre/post General Health Survey, the Pittsburgh Sleep Quality Index survey, and the Self Administered 
Gerocognitive Examination. Each procedure is described in detail below. 
Anthropometrics: Participant height and weight will be measured and their BMI (kg/m²) will be calculated. 
Participant resting blood pressure (mmHg) will also be taken. 
Urine sample: Participants will be asked to provide a urine sample to ensure proper hydration for DXA scans.  
Blood Draw: 7-10 ml of blood will be drawn from the subject using a butterfly needle and vacutainer. These 
samples will be allowed time to clot and then spun in serum separator tubes. Serum will then be aliquotted into 
microtubes and stored till bone turnover assay can be ran. Samples will be stored in Gwynn Hall and analyzed 
at the Missouri Orthopaedic Institute. 
DXA Scan: The total body DXA scan requires participants to lie still for approximately 6 minutes on a padded 
table. Specific scans of each proximal femur and the lumbar spine will also occur. Participants are exposed to a 
small amount of radiation during the scan equivalent to about 1/1000 of a similar Computed Tomography scan. 
Participants will undergo the same scanning procedures before and after the intervention period. After testing is 
complete for the visit, research staff and participants will discuss the DXA results and a copy will be provided. 
10 meter Walking Test (10MWT): the test is designed to measure gait speed. The test requires participants to 
walk for 10 meters and the time taken to cover this distance will be recorded. This will be repeated three times 
and the scores will be averaged. Participants will perform the same test after completion of intervention period. 
CDC Balance Test: The CDC Balance test is a widely used balance assessment where participants take on four 
different postures and must maintain balance. Participants will complete each posture as described in the CDC 
protocol. In addition, we will have participants complete this task on two force plates in order to record more 
sensitive data. Participants will perform the same test after completion of intervention period. 

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Grip Strength: Hand strength is measured by using a Jamar hand dynamometer. This test requires the subject to 
hold the dynamometer and squeeze with maximum isometric effort, which is maintained for about 3-5 seconds. 
Three trials will be performed and the greatest value will be reported. Participants will perform the same test 
after completion of intervention period. 
Back Scratch and Sit and Reach Flexibility Tests: Both of these static flexibility tests are commonly used in 
older adults. The back scratch test required participants to reach one arm behind their back and try to touch it 
with the other hand that is above their head. The distance each hand is away from each other or overlaps 
provides an upper body flexibility score. Both sides will be tested. The sit and reach test can be completed on 
the floor or from a chair to accommodate older adults who cannot safely get on the floor. During this test, 
participants try to reach their toes with their legs straight. The distance the hands are away from the toes or the 
distance they overlap the toes provides a lower body flexibility score. 
Timed up and go (TUG) and 30 second sit to stand (30STS) Tests: Both of these dynamic tests are used to 
assess a participant’s balance and lower body strength. The TUG requires participants to rise from a seated 
position, walk around a cone 8 ft away and return to their seated position. Participants will be timed during this 
test. The 30STS has two commonly reported variations. First, is how quickly a participant can rise from a seated 
position, fully stand, and return to the seated position five times. The second iteration is how many times can a 
participant complete this same complete motion in 30 seconds. We will measure both. Additionally the 30STS 
will be completed on two force plates to better understand lower body power and balance. Participants will 
perform the same test after completion of intervention period. 
Once participants have enrolled in the study Dr. Duren will randomize the participants into either the 
experimental group, walking group, or sedentary group. They will be notified of their assignment based on their 
preferred communication method by Dr. Duren. 
Participants who are assigned the SSSH program will engage in eight weeks of strength training and will be 
able to take those classes free of charge. Normal SSSH sessions follow the same general principles. All exercise 
training sessions are completed under the supervision of trained exercise personnel. The classes consist of group 
strength training, balance and flexibility twice a week for eight weeks. Each session begins with a 5 min warm-
up period, followed by two sets of ten repetitions of eight strength exercises including, but not limited to wide 
leg squat, standing leg curl, knee extension, side hip raise, biceps curl, overhead press, seated row and toe stand. 
Exercises are subject to change and will vary with each individual as needed to ensure progression and 
specificity. Classes end with a 5 minute cool down period including light stretching and breathing exercises.  
Participants who are assigned to the walking group will be asked to refrain from any strength training or 
auxiliary forms of physical activity outside of the designated walking group. Two times per week SSSH 
personnel will guide these walking groups for about 45 minutes of total exercise time. Participants who 
complete the study will be automatically enrolled in the next SSSH program free of charge. 
Participants who are assigned to the sedentary control group will be asked to refrain from any strength training 
or auxiliary forms of physical activity for the duration of the study. Participants who complete the study will be 
automatically enrolled in the next SSSH program free of charge.  
Statistical Analysis- All data will be tested for normality. Baseline characteristics will be assessed using a one-
way ANOVA. A repeated measures ANOVA with between and within effects will be used to track 
physiological changes over time in each group. Pearson’s correlations will be used to better understand 
relationships between variables. Rates of change will also be calculated and will be assessed using t-tests.  
Potential Risks/Adverse Events 
The research team has taken extensive measures to reduce risk and the potential for adverse events. Both 
participant and research staff safety are a priority. We will minimize these risk by taking the following 
precautions: 

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 Standard aseptic technique will be used for drawing blood and only trained personnel will complete 
blood sample, DXA scans, and functional testing. 
 This research does not involve vulnerable populations and we are not collecting any highly sensitive 
personal or medical information (e.g. social security numbers, banking information, HIPAA 
information) and do not expect any of the collected data to impact a participant’s employment, 
insurability, social status, or reputation if it were to become public. 
 Subjects’ information will be coded and will be stored on University of Missouri secure database and we 
will follow a strict protocol to ensure patient confidentiality at all times. 
 Subjects are asked to perform balance assessment tests close to a wall under the supervision of trained 
personnel to avoid falls. Trained research staff will always be within reach to aid a participant if they 
lose their balance. Participants will never be left alone to complete a task. 
 
Any serious adverse events will be reported directly to the IRB, please see the Data Safety Monitoring Plan 
below for more details. In case of emergency, the electromyography, dual x-ray absorptiometry, or blood 
drawing process will be immediately stopped.  We will dial 911 in the case of emergency.  
 
Anticipated Benefits 
Potential benefits experienced by the participant include: decreased risk of fall and frailty; improve sleep and 
cognition; increased muscle mass and strength; and improvements in bone turnover rates. Potential benefits to 
society include the curbing of the declining physical and mental capacity among seniors, which are key risk 
factors for falls. Strength training has been shown to mitigate these factors in seniors, ultimately saving the 
healthcare system billions of dollars in associated costs. 
 
Compensation 
All participants who enroll in the study will be eligible for waived class fees for one eight week SSSH 
intervention, valued at $65. Participants who are randomized into the SSSH intervention will have the waiver 
immediately applied. Participants randomized into either the walking group or the sedentary control group will 
be able to enroll in the SSSH program free of charge after the research study is complete. All participants who 
complete the study will also be compensated $100 via check for their time.  
 
Costs  
The costs for this study and procedures will be paid through internal departmental grant funding through the 
Department of Nutrition and Exercise Physiology and University of Missouri-Extension. For instance, 
laboratory fees associated with the blood draw and DXA scans will be waived by the Department of Nutrition 
and Exercise Physiology. Equipment and personnel costs will be covered by both entities. 
Total Personnel Costs = $16,517    Total Equipment Costs = $7,249   Total Participant Compensation = $6,000 
 
Data Safety Monitoring Plan 
In order to protect the participants’ personal information, data, and right to privacy this research team will take 
extensive precautions to maintain confidentiality. After the participant has cleared the initial screening forms 
and signed the informed consent all remaining surveys, questionnaires, DXA results, blood samples, and data 
sheets will only contain the participant’ identification code. The key linking names and participant identification 
codes will be accessible to Dr. Dana Duren and she will only share the key with the research team once 
unblinding is necessary. All paper records will be kept in a locked filing cabinet in Dr. Duren’s MU office (she 
is a Professor and Director of Orthopaedic Research and is familiar with handling confidential documents). 
Computerized records of experimental data will be similarly coded and will be maintained on a password 
protected MU secure computer. Copies of signed consent forms, as well as the experimental log book, are kept 
in a locked file cabinet in Dr. Duren’s office. Participants will not be individually identified in any publications. 

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Additionally, all adverse events and/or unanticipated problems will be evaluated by Drs. Duren, Ball, and Baker 
as they occur, for subject safety and appropriate follow-up assessment, treatment, or care. All adverse events 
and/or unanticipated problems will be evaluated and assessed to answer the following questions: Is the event 
unexpected? Is the event related or possibly related to participation in the research? Does the event suggest that 
the research places subjects or others at a greater risk of harm than previously known or recognized? If all three 
answers are “yes”, the event will be reported to the IRB within 5 days of the investigator becoming aware of the 
event. While reviewing each event, the PI(s) will determine if it is safe for the subject to continue participating 
in the trial and if it is safe to continue enrollment and research activity for all subjects. 
Multiple Sites 
University of Missouri is the only site where research activities will occur. All required approvals are in 
order for the three specific rooms where data will be collected and analyzed.  
 
References/Appendices 
1 Seguin, R.A., Economos, C.D., Nelson, M.E., Hyatta, R., Palomboa, R., & Reed P. Design and National 
Dissemination of the StrongWomen Community Strength Training Program. Prev Chronic Dis 5 (2008). 
2 Seguin, R.A., Folta, S.C., Nelson, M.E., Hanson, K.L. & LaCroix, A.Z. Long-term body weight maintenance 
among StrongWomen–Healthy Hearts program participants. J Env Public Health 2017: 6pgs (2017). 
3 Guizelini, P.C., de Aguiar, R.A., Denadai, B.S., Caputo, F. & Greco, C.C. Effect of resistance training on 
muscle strength and rate of force development in healthy older adults: a systematic review and meta-analysis. 
Exper Geronto 102, 51-58 (2018). 
4 Foster, C. & Armstrong, M. What types of physical activities are effective in developing muscle and bone 
strength and balance. J Frailty, Sarcop Falls 3, 58-65 (2018). 
5 Beavers, K.M., Walkup, M.P., Weaver, A.A., Lenchik, L. Kritchevsky, S.B., Niklas, B.J., Barbara, J., 
Ambrosius, W.T., Stitzel, J.D., Register, T.C., Thomas, C., Sue, A. Effect of exercise modality during weight 
loss on bone health in older adults with obesity and cardiovascular disease or metabolic syndrome: a 
randomized controlled trial. J Bone Min Res 33, 2140-2149 (2018). 
6 Northey, J.M., Cherbuin, N., Pumpa, K.L., Smee, D.J. & Rattray, B. Exercise interventions for cognitive 
function in adults older than 50: a systematic review with meta-analysis. Brit J Sports Med 52, 154-160 
(2018). 
7 Syed-Abdul, M.M., Peterson, E.C., Mills-Gray, S.L., Parks, E.J. & Ball, S.D. Stay Strong, Stay Healthy: 
University of Missouri-Extension’s Strength-Training Program for Older Adults in Community Settings. Med 
Sci Sports Exer 48:5, 125-125 (2016). 
8 Crowe, E.M. & Ball, S.D. Effectiveness of advanced stay strong, stay healthy in community settings. 
Gerontol Geriatric Med 1, 2333721415596462 (2015). 
9 Ball, S.D., Gammon, R., Kelly, P.J., Cheng, A., Chertoff, K., Kaume, L., Abreu, E.L., Brotto, M.  Outcomes 
of stay strong, stay healthy in community settings. J Aging Health 25, 1388-1397 (2013).