Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program
Phase: NA
Conditions: Accidental Falls
Sponsor: University of Pittsburgh

 
 
Living in Fitness Together (LIFT): Testing an Innovative Fall 
Prevention Program 
 
NCT02732366 (H-34736) 
 
Protocol Synopsis from Manual of Operating Procedures 
Version 7-25-2016 
 
 
 
 
 
 
 
 
This research was funded in part by a 
Magistro Family Foundation Research Grant
from the 
Foundation for Physical Therapy
www.foundation4pt.org

Introduction 
 
Falls are the leading cause of non-fatal and fatal injuries in older adults.1 Overall, 30% of adults 
over 65 fall every year, and the risk for falls increases dramatically with age.2 Direct medical 
costs related to falls was estimated as 19 billion in 2000.3 In 2005 there were 15,802 fall-related 
older adult deaths,1 and in 2006 5.8 million older adults (16%) reported a fall in the prior 3 
month period and 1.8 million had been injured.4 Falls have major impacts on older adults, with 
potential for catastrophic mobility decline, loss of independence and institutionalization. The 
current trend in aging of the population makes this a critical problem for our time.  
Current evidence and guidelines recommend multi-factorial assessment and intervention 
for older adults at increased risk of falls.5,6 Strength, balance and gait training are among the 
most potent intervention components. Yet we know that fall risk benefits accrued from exercise 
are completely lost within 12 weeks.7 The APTA recently published a Clinical Guidance 
Statement (CGS) for the management of falls in community-dwelling older adults.8 The CGS 
underlined the gap between exercise intervention available within current physical therapy 
delivery models and substantial levels of challenging exercise required to achieve optimal fall 
prevention outcomes. It called for future treatment models to address behavior change, self-
efficacy, and adherence to ongoing physical activity and structured exercise.”8 There is a critical 
need for fall risk management that systematically integrates patient-centered self-management 
to optimize long-term risk reduction.  
The proposed project, Living In Fitness Together (LIFT) tests the feasibility and 
preliminary efficacy of a group-based PT fall prevention program using a within-group peer 
coaching intervention to improve outcomes for older adults at risk for falls by promoting 
sustained patient engagement in exercise and physical activity. The program will consist of 
group-based physical therapy for balance, strength, flexibility, and mobility training combined 
with a behavioral theory-based goal-achievement and peer-coaching training intervention 
targeting self-efficacy for the patients/group participants. It consists of 8 group sessions over 6 
weeks plus one group booster session delivered by a physical therapist (PT) and trained staff.  
The program is designed to: 1) deliver progressive, tailored, and challenging exercise 
intervention for older adults at risk for falls; 2) empower older adults to achieve the required 
milestones for exercise and physical activity through training in theory-based behavior change, 
self-management, peer support and peer-coaching applied among the group participants; 3) 
incorporate evidence-based home safety intervention with necessary support for implementation 
of modification recommendations. By focusing on peers empowering each other within PT 
intervention as the center of exercise-based fall prevention for long-term patient engagement, 
this project will provide an innovative model for successful fall prevention.   
Our Specific Aims are to:  
1. Assess the feasibility of implementing the peer-coaching program in the physical therapy 
practice context by measuring enrollment, attendance, and completion of the program.  
 
2. Evaluate whether the LIFT Fall Prevention program creates long-term behavior change as 
measured by exercise adherence at 6 months. 
 
3. Evaluate safety and preliminary efficacy of the LIFT Fall Prevention program among 48 
patients within an outpatient physical therapy practice. Safety will be assessed using self-
reported falls, injuries, and adverse events. To support trial design for a future comparative 

trial, we will measure indicators of initial efficacy including lower extremity strength and 
function, balance, balance confidence, concern about falls, mobility, physical activity, self-
efficacy for exercise, and exercise adherence.  
 
Intervention Program 
 
Exercise Component 
The design of the group exercise intervention is based on the evolving evidence for 
exercise and fall prevention.8 This component was modified based on the evidence- based 
Otago Exercise Program (OEP),9 and leverages preliminary research in a group-based 
modification.10  It was designed to meet PT best practice recommendations for fall prevention 
from the APTA Clinical Guidance Statement8 results of Sherrington et al.’s updated exercise 
meta-analysis and best practice recommendations,11 and Power and Clifford’s review: 
Characteristics of optimum falls prevention exercise programs for community-dwelling older 
adults.12  This includes progressive, challenging exercise for strength, balance training, mobility 
and gait training. The intervention will also meet physical activity recommendations from the 
American College of Sports Medicine (ACSM) and American Heart Association (AHA).13 
The strengthening /resistive and balance/neuromotor exercise components are based on 
the Otago exercise program with the addition of UE strengthening as recommended by ACSM 
guidelines. Cardiorespiratory/endurance exercise will be encouraged through an individualized 
progressive walking home program with the use of accelerator meter for feedback once cleared 
by the physical therapist. Flexibility exercises will be incorporated into the exercise program or 
within the peer coaching session.  
 
The program frequency is two sessions/week for two weeks, decreasing to one 
time/week for 4 weeks. An additional group booster session will be scheduled 3 months post 
initiation of the program. The hour sessions will be divided between PT and a trained provider, 
initially forty five minute sessions for the first two weeks, for the physical components and 
education for tracking home exercise program. The exercise component will decrease to thirty 
minutes and increased time will be allotted to the goal-achievement component of the program. 
 
Intensity for all components will be measured by self-report using the modified Borg 
Rating of Perceived Exertion (RPE) scale from “somewhat hard” (5-6) to “vigorous” (7-8).14, 15 
Exercise duration will be adjusted according to intensity.  
 
The strength training component will target at least seven major muscle groups, knee 
flexors, extensors, hip abductors and extensors, ankle dorsiflexors and plantar flexors. The 
addition of 3 upper extremity exercises is an addition to the Otago program based on ACSM 
recommendations for older adults and these elements will be based on Miriam Nelson’s 
Osteoporosis programs.  Participants will be advised to perform 2-3 training sessions/week or 
split the sessions into two shorter sessions of 3-4 muscle groups.  Initial resistance for exercises 
will be individualized based on current recommendations and tolerance.  Strength training will 
be monitored so the amount of resistance can only be done 8-15 repetitions before muscle 
fatigue. The therapist will monitor for muscle substitution, proper breathing, exercise technique 
and timing and provide guidance to ensure that exercise level is challenging.  
 
The balance training will incorporate progressive activities that reduce the base of 
support, leaning beyond base of support, shifting center of mass, minimizing upper limb support, 

coordination of single/dual tasks with cognitive challenges. Training and guidance will be 
provided to tailor exercise to meet the requirement for all exercises to be challenging. Dynamic 
walking activities including obstacle courses for functional activities and strategies for transfers 
to and from the floor will be included.   
 
The flexibility exercises will include a static stretching program involving all major 
muscle groups and yoga based stretches in both sitting and standing  after warm up or cool 
down. 
 
The endurance/walking will be prescribed based on examination results throughout the 
group sessions. Patients who are deemed safe for a  home walking program will receive 
guidance for tailored, progressive walking program with the goal of >=3x/week. The intensity of 
walking will be self-rated using the Borg scale, and duration goals will be adjusted accordingly.  
 
The home program will be based on the evidence-based Otago program, modified and 
individually tailored based on the goals and exercise progression achieved in the group 
sessions. Patients will be provided with exercise program materials based on the Otago manual, 
including calendar and exercise diary to manage and document exercise performance and 
progression. The manual will include detailed instructions for the material presented in group 
sessions, with visual aids, including frequency, intensity, time by exercise type, instructions for 
progression and use of the Borg scale to guide intensity. Patients will record steps taken as 
reported by their accelerometers in their exercise diary.  
 
At the 3 month and 6-month visits, all tests will be conducted and measures 
administered, and exercise logs will be copied, and patients will provide self-reported exercise 
frequency and duration over the past month. At the 3 month session the physical therapist will 
discuss present program; review tracking system for home exercise program; review exercise 
intensity levels based on the Perceived Exertion Rating for each exercise type (e.g. resistance 
and walking). Individual progression and/or modifications will be determined by the physical 
therapist. The Goal-Setting program lead will facilitate a discussion about how goal-setting and 
peer-coaching activities have been going. Figure 1 provides a study diagram and Figure 2 
illustrates the overall flow of content across the duration of the program.  
 
 
 
 
 
 

Figure 3. Study Flow Chart 
Measurement  
Patient Flow 
Exclusion Criteria 
 
 
Figure 2. Flow of Program Contents up to 6 weeks 
 
 
Safety of the program will be monitored by tracking self-report of falls, injuries, and 
adverse events. Participants will record falls or other adverse events in their tracking system, or 
Action Plan. They will be instructed to report all events to the clinical investigators. In addition, 
the research assistant will conduct calls bi-weekly telephone calls to collect these data.  
Older Adult Patient 
Referred to PT for 
Balance/Mobility/Gait Disorder
or Judged by PT at Risk for 
Falls
PT Evaluation 
Eligible to Participate
in Program 
Exclusion Criteria:
•
Age<65
•
Unable to participate
in group
•
Active vertigo
•
Postural hypotension
•
Unstable cardiac disorders
•
Significant neurological 
conditions
Refuse 
Completes Informed Consent Process
Participates in Program 
Participates  in Control Program 
Baseline 
Measures
End Program (6 weeks)
End Control Program (6 weeks) 
6-week  
Outcomes
3 month Booster Visit 
Control Visit 
3-month post  
Outcomes
# Referred
# Eligible
# Enrolled
Follow-Up Visit 
6-month post  
Outcomes
Follow-Up Visit 
Random Assignment
 
PHASE I
Week 1-2
PHASE II
Weeks 3-4
PHASE III
Weeks 5-6
PT sessions, for 
exercise, balance,
mobility training
Adherence training
Peer coaching training
Peer coaching
Technology based goal achievement tracking

 
Goal Achievement Component 
 
The overall framework for the Goal Achievement component of the intervention is Social 
Cognitive Theory, as illustrated below in Figure 3.  
 
 
 
Figure 3. Goal Achievement Component  
 
 
 
 
Self-Efficacy
Progressive Exercise 
and Physical Activity
Goals
• Short term
• Long term
Sociostructural Factors
• Facilitators
• Impediments
Outcome Expectations
• Program: 
• Long Term Exercise Adherence
• Patient: 
• Physical 
• Social 
• Self-Evaluative
Bandura, A. (1977). Self-efficacy: toward a unifying theory of behavioral change. Psychological 
Review 84(2): 191-215.

The three main dimensions of the Goal Achievement component include: 
1. Goal Setting 
2. Self-Assessment 
3. Self-Awareness 
During the program, participants will be provided with education and participate in guided, 
individualized and group activities to promote independence in each of the three dimensions.  
 
Goal Setting 
Participants will receive education and training in goal-setting throughout the program. Goal 
Setting is a shared provider/participant activity that includes consideration of outcome 
expectations, potential short term (ST) and long-term (LT) goals, confidence in achieving the 
goals, potential facilitators and impediments, and problem-solving.  
 
In order to facilitate Goal Setting the provider will work with participants to complete a Goals 
Worksheet (Appendix A). The provider will discuss and complete the overall program goals and 
individualized PT goals with the participant, and ask the participant to complete the activity 
goals. 
Participants will be asked to refer back to these goals on a weekly basis and adjust the goals as 
appropriate. To support achieving their short term and long term goals, we will teach 
participants to create weekly Action Plans (Appendix B) in which they will include the specific 
action(s) they will take, and include details such as intensity, duration and frequency of exercise 
for the week. Within the Action Plan, participants will rate their confidence in carrying out the 
action plan as follows:  
 
How much confidence do you have that you will complete the action plan? 
None  at all  A little  
A lot  
Full confidence 
o  
o  
o  
o  
 
We will teach participants skills to use when they find that their confidence in achieving the 
goals is low. Identification of barriers and facilitators, brainstorming and experimentation will be 
used as described in Self-Assessment below. 
 
Self-Assessment 
Self-Assessment will be framed as dialogue with oneself, with peer coaches, or other sources of 
social support. The approach is aimed at fostering experiential learning and development of 
self-efficacy for exercise. A key feature of the training will be the focus on teaching participants 
to model the target behaviors in their group interactions. We will train participants to ask and 
answer key questions to assess their progress, build self-efficacy, problem-solve, and take 
positive action to achieve their goals (Appendix C).  
Sample questions include: 
• 
What went well? Did I do the exercises and activity I planned?  
• 
What were my challenges?  [Impediments/barriers] 
• 
What are some solutions I could try/What could I do next time? 
• 
Which one(s) will I try first? 
 
Participants will use these questions to foster problem solving with an emphasis of 
experimentation, and solution focused success.  Participants will be encouraged to write out 
their responses to the questions and to share with the group.  If they report success then they 

will be demonstrating good role modeling for the group.  If they report barriers, then the group 
can help with group problem solving, by practicing brainstorming.  They will identify the 
barrier(s), pick one, then brainstorm with the group and lastly chose one to try during the coming 
week.  These steps will be repeated weekly by all participants to encourage experiential 
learning, self-efficacy and adherence to their exercise program and incorporated into their 
interaction in the peer-support sessions.  
   
 
 
Self-Awareness 
We will teach participants skills and activities to promote self-awareness and self-efficacy and 
independence in managing their impediments to goal achievement. Examples of activities will 
be self-rating of confidence in accomplishing goals (as shown in goal-setting above) level of 
calmness/peacefulness, stress, and energy and symptom levels. We will teach simple 
management strategies such as breathing and position and activity changes to improve self-
efficacy and management. We will use self-rating to teach awareness.  The following are 
examples of questions that can be asked.  A worksheet of self-awareness self ratings will be 
provided in the binder (Appendix D) 
 
Below are two examples: 
How stressed do I feel right now? 
Not  at all  
A little  
Very      
 
o  
o  
o  
 
 
How much energy do I have right now? 
None  at all A little  
A lot    
 
 
 
 
 
 
Peer-Coaching Component 
The goal of the Peer coaching component is for team members to provide social and emotional 
support to each other to support achievement of the exercise adherence goals. Peer coaching is 
a process in which 2 or more team members work together to implement their individual 
exercise Action Plans by modeling problem-solving and social and emotional support skills.  
This process includes sharing feelings, successful experiences, challenges, ideas, and results 
of personal experiments, and reinforcing skill achievement.  In LIFT peer coaching is conducted 
by the participants themselves, rather than graduates or older adults who have succeeded in 
long-term adherence to exercise. The emphasis of the LIFT program is on learning adherence 
and peer support skills together.  
 
Participants will receive instruction and training in roles and responsibilities and basic peer 
support skills including active listening, such as restating, summarizing, minimal encouragers, 
reflecting, giving feedback, using simple follow-up questions, validation, effective pause, and 
avoiding communication blockers. We will also teach the use of open and closed-ended 
questions. This material will be taught using lecture, discussion, video as well as role playing in 
which the participants will practice specific skills in multiple group sizes (pairs, and groups of 4) 
in the context of their own exercise goals. We will ask participants about their current technology 
use and incorporate technology as appropriate, including group calls and social media. We will 

teach the participants how to conduct a group call/session, and how to fulfill the role of 
facilitator. 
 
Support materials such as scripts and choices of probes are provided in the LIFT binder. 
Participants will have the opportunity to debrief after they practice the skills, and after they try 
peer-coaching on their own. They will be provided with contact information for the research 
team for questions or problems. Figure 4 below provides a detailed model of the elements of the 
Goal Achievement component.  
 
Figure 4. LIFT Goal-Achievement Component to Improve Self-Efficacy and Exercise 
Adherence 
 
 
 
The Overall Program Goals: 
A. Long term adherence and self-efficacy for home exercise program 
B. Improve strength, endurance and balance measurements to level of low or no risk for 
falls 
 
 
 
Patient Education
• Benefits of Exercise
• FITT Requirements 
Overall Program Goals
• Long Term Exercise Adherence
• Optimal FITT
Initial Pt Outcome Expectations
•
Physical 
•
Social 
Informed Patient Outcome 
Expectations
Goal Setting
• Short & long term
• Action plan 
Self Assessment
• Facilitators
• Impediments 
Execute
Self Awareness
• Monitoring
• Management
Long Term 
Exercise 
Adherence
PT Evaluation
• Individualized PT 
goals for patient

Individualized PT Goals for Participant 
 
Long Term Goals (12 weeks) 
1. Participant demonstrates knowledge and understanding of components of 
home exercise program (flexibility, strengthening and endurance) including 
progression, proper technique and modifications. They will demonstrate 
proper and safe use of adjustable leg weights and pedometer. 
2. Participant will meet the following goals : 
a. Walking 7,000-10,00 steps 3 or more days/week 
b. Perform strengthening exercises 3 days/week 
c. Perform balance exercises 3  or more days/week 
d. The total exercise goal per week will be at least 2 hours 
3. Participant will meet personal functional goal as established at start of 
program.  
4. Peer coaching goal: Participants will connect via phone or social media 1-2x 
weekly with a member of their peer coaching team. 
Short term goals: 
1. End of week 2 
a. Demonstrate use of pedometer tracking device and use flow chart to 
track steps taken per day  
b. Demonstrate use of ankle weights for strengthening exercises and 
flow chart to record flexibility, strengthening and balance exercises. 
c. Peer coaching goal. They will demonstrate active skills in small 
groups and 1:1. 
2.     Goals for week 3, 4, 5, 6 to be individualized on action plans 
a. Track weekly progress on flow chart  
i. steps walked/time walked per day  
ii. Repetitions and weights for strengthening 
b. Progression of balance exercises with diminished use of UE support 
 
c. Peer coaching goals: Participants will be able to demonstrate active 
peer coaching and support by utilizing the self-assessment questions 
 
 
Home Safety Evaluation 
Each participant in the LIFT study (intervention and control groups) will have the opportunity to 
have a home safety evaluation by an Occupational Therapist (OT) at no cost the participants or 
their insurers. The goal of the home evaluation will be to help the participant to identify any 
environmental changes or equipment that could decrease their risk of falling and make everyday 
tasks easier and safer at home.  
 
At the time of baseline data collection, a series of questions will be administered to the 
participants to gather information about prior home safety evaluations and planning information, 
including whether or not the participant would like a home safety evaluation. Based on the 
results of these questions the OT investigator will follow-up with the participant to provide 
guidance or to schedule and conduct the home safety evaluation.  
 
The OT will use the HOME-FAST tool to guide the home safety evaluation and to document 
results and recommendations (Appendix E) 
 

Control Program 
The control group will continue with "usual care" one-on-one physical therapy. In addition, they 
will attend a control group class that provides social interaction and interesting health 
information. They will be asked to track when and how much they do their PT home exercise 
program, walking, and any falls or adverse events or problems. Below is a description of the 
control group class.  
"Healthy YOUniversity" is a program developed by Boston University and Mt Ascutney 
Hospital and Health Center (MAHHC) for the Living In Fitness Together Research Study to 
provide group education about activities and behaviors that promote healthy living. This 6-
session program includes the following topics:  
 
Home Safety: Content will be provided in the participant binder to address the range of ways to 
enhance safety inside and outside of the home. This content will be reviewed in the orientation 
session so that questions can be answered and participants can expect the OT's call.  A Home 
Safety Assessment by an Occupational therapist will be offered, as described above in the 
Home Safety Assessment section.  
Session 1. New Stress Paradigm.  This session will discuss stress within the context of the 
Energy In - Energy Out paradigm.  Participants will learn examples of healthy activities and 
choices across a range of topics including nutrition, sleep, positive thinking, social support, 
meaningful activities, and exercise. Activities and choices that may deplete energy and overall 
health will be discussed. Tools such as visual imagery, mindfulness, breathing exercises, and 
simple techniques to enhance healthy sleeping patterns will be presented.  Handouts will be 
provided in the participant binder. 
Session 2. Nutrition. This session will teach the heart healthy diet as outlined by The American 
Heart Association, National Institutes of Health and the American Medical Association. 
Handouts from government websites will be provided in the participant binder. 
Session 3. Leisure Education for Quality of Life. This session will explore the PIESS 
approach to including a variety of healthy leisure activities.  
• 
P: Physical 
• 
I: Intellectual 
• 
E: Emotional/Relaxing 
• 
S: Social 
• 
S: Spiritual/Meaningful.   
Session 4. Social Capital This session will define social capital and how it aids a healthy 
lifestyle. Examples will be discussed including sharing information and resources, providing 
assistance, and building trust.  
Session 5. Resilience What does the science say about bouncing back from a major life 
stressor?  This session is based on the SAMHSA-HRSA Center for Integrated Health Solutions 
and will describe resilience and discuss the importance of this quality for our health.  

Session 6. Community Resources: What resources are available in the area to help improve 
overall health and well-being?  A comprehensive list of community resources will be provided in 
the participant binder and discussed.  
Tracking Exercise.  An activity log will be used to track exercise adherence, falls, and adverse 
events during and after the class.  (Appendix F). 
 
Documentation of PT and OT Services  
 
PHYSICAL THERAPY 
Participants who are eligible, have signed consent and are waiting for randomization (16 
subjects) will begin one on one PT if time is >1 week for baseline testing. Documentation per 
protocol for outpatient PT. 
After randomization: 
All participants will undergo baseline data collection.  
Control Group 
Data will not be entered into eChart for Control Group. Data collection will be filed in a secure 
place and sent to BU for analysis. Patients will be registered under Recurring encounter for 
Therapies if they have not started outpatient PT or continue with primary outpatient PT. PT 
documentation will be performed by the PT as per the outpatient protocol in eChart.  
Intervention Group 
After baseline data collection the PT will conduct functional evaluation to determine appropriate 
starting level for the exercise program. The results will be documented under OUTPATIENT PT 
Progress note with Plan of Care by PT. There will be no charges and 0 (zero) will be inserted in 
charge and time under neuromuscular/Balance. 
If a participant has been treated in outpatient PT and is randomized into the intervention group 
the patient will be discharged from PT, registered under the LIFT study and recurring encounter 
will be discharged.  
Ongoing PT documentation: The PT will complete the Daily Documentation form using Group, 
Ther activity and Ther exercises and Education tabs as needed.  Subjective, Assessment and 
modifications of Plan of Care will be documented. Time and Units will be entered as 0 zero 
under Neuromuscular and Balance. 
At the end of the program, PT flow chart of attendance and progression of exercises will be 
scanned into the chart. 
This encounter will stay open until end of data collection at 6 months. 
 
 

Baseline, 6 week, 3 month and 6 month Data Collection. 
Intervention group 
Data from baseline testing plus additional strength test and POC will be entered in 
Progress Note. 
6 week testing will be entered in the last session for the Intervention group (discharge 
information in last daily documentation note as would be in standard PT practice.) 
3 month booster session will be reported in Note by PT/TR titled Intervention Booster 
Session. No data will be entered into E Chart. 
6 month testing- Note will be entered by PT/TR documenting they participated in testing 
for LIFT study. No data entered into E Chart. 
CONTROL group 
Initial, 6 week, 3 and 6month testing data will not be entered into eChart. A note will be 
entered by PT/TR documenting that they participated in testing for LIFT study. 
OCCUPTATIONAL THERAPY 
Home Safety Evaluations  
The provider conducting home safety evaluations will complete the HOME- FAST form 
(Appendix E) and assess mobility in the home, and identify environmental obstacles and 
hazards. Recommendations will be written and shared with participant. Both forms will be 
scanned into the medical chart. Time Spent with Patient ad hoc outpatient form will be used and 
0 (zero) will be entered under Ther Act for time and units with patient. 
 
Therapeutic Recreation Services (both groups)  
INTERVENTION GROUP: The therapeutic recreation therapist will document using Recreation 
Therapy Progress Note. As per usual care, there will be no charges. 
CONTROL GROUP – The therapeutic recreation therapist will track attendance and there will 
not be any additional documentation. 
 
Training 
 
MAHHC Outpatient Physical Therapists 
 
LIFT investigators will provide information to the Mt Ascutney physical therapists who will 
be identifying eligible patients during a one-hour session. Information about the study and the 
eligibility criteria will be provided. The physical therapists will be trained in how to use the 
eligibility form, and where to submit it (Eligibility Form: Appendix G; Training Form for Outpatient 
Therapists: Appendix H). Printed copies of the Participant Study Summary will be provided.  
 
MAHHC Secretaries 
 
The MAHHC secretaries will fax the eligibility forms and refer calls about the study to 
Linda Hazard. A contact list for study investigators will be provided to the secretaries.  

 
LIFT Research staff 
 
Each member of the research staff will undergo Human Subjects protection training via 
CITI courses through Boston University. In addition, they will attend a 2 hour study-specific 
training in LIFT procedures conducted by the principal and co-investigator. A one hour retraining 
session will occur prior to the 2nd and/or 3rd class session if more than 6 weeks has elapsed 
between sessions.  This content will include study specific human subjects protection, study 
procedures, data collection, adverse event reporting, including reporting if assessor is unblinded 
to study assignment. In addition to this training, members of the research team conducting the 
exercise class, the behavioral component (Goal-setting and Peer-coaching), the control 
sessions, and data collection (including adverse events) will undergo component-specific study 
training 
 
Exercise Component:  Providers conducting the group exercise component will 
complete certification in the Otago program, and undergo 1 hour training in study-specific 
content and progression of the group class, activity monitor use, and study documentation. See 
Appendix I: Training documentation form and Appendix L: Training for Exercise Component.  
 
Data Collection: The data collectors will be trained in administration of the study 
questionnaires, and in the physical performance tests. See Appendix I: Training documentation 
form; Appendix J: Physical Performance Test Training Log; Appendix K: Physical Performance 
Tests: Strength, Balance, and Walking Assessments 
 
 
LIFT Study subjects 
Identification 
Outpatient physical therapists will identify potentially eligible patients using the Eligibility form 
provided (Appendix G). If the patient is eligible, the physical therapist will inform the patient of 
the study and ask if they are interested in hearing more about it. They will provide the study 
summary to the patient, provide contact information on the Eligibility form, and let the patient 
know that study staff will contact them. They will submit the forms to the outpatient PT 
secretary, who will contact Linda Hazard to alert her that an eligible participant has been 
identified.  
 
Enrollment 
Study staff will call the patient to provide information on the study, answer questions and set up 
a time to enroll, likely before or after the next physical therapy session. At that session, study 
staff will provide specific information on the class meeting times and commitment, and clarify 
that the start date is to be determined when all 16 participants have been enrolled. She will 
obtain written, informed consent, and let the participant know that study staff will call them about 
when the program will begin. Linda will complete the Master Key document (Appendix M), 
assigning the participant a study identification number (study ID). The study ID will be used to 
identify the participant in the consent form and data collection forms. 
 
Randomization 
Linda will insert the study ID, age and sex into the Randomization Spreadsheet (Appendix N). 
When 16 IDs are listed on the sheet, she will email to the blinded study analyst, who will use a 
computer algorithm to randomly assign the participants to study condition, blocked by age and 
sex. The analyst will send the spreadsheet back to Linda with the assignments. 
Notification 
Unblinded study staff will contact the patients to notify them of their study group assignment, the 
day and time of the baseline data collection, and the schedule of the group sessions. Study staff 

will inform the participants that at the baseline data collection, the data collector will not know 
their study group and should not be informed.  
Data Collection 
Feasibility Data 
We will use the eligibility form (Appendix G) to collect data on:  
 
Number eligible 
 
Number refusing. 
We will collect number consenting from the consent forms 
We will track class attendance using an attendance sign-in sheet (Appendix O) 
Cancellations (notification) and no-show status will be tracked by the class instructor (Linda for 
Intervention and Michael for control).  
Adverse Event Monitoring and Reporting  
We will follow the guidelines of Boston University Medical Campus (BUMC) IRB with respect to 
defining and reporting adverse events, serious adverse events and unanticipated problems.  
The following definitions will be used: 
Adverse Event (AE) is any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign (for example, abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the subject’s participation in the research, 
whether or not considered related to the subject’s participation in the research. 
SERIOUS Adverse Event (SAE) is any adverse event that 
Grade (1) results in death; 
Grade (2) is life-threatening (places the subject at immediate risk of death from the event as it 
occurred); 
Grade (3) results in inpatient hospitalization or prolongation of existing hospitalization; 
Grade (4) results in a persistent or significant disability/incapacity; 
Grade (5) results in a congenital anomaly/birth defect; or 
Grade (6) based upon appropriate medical judgment, may jeopardize the subject's health and 
may require medical or surgical intervention to prevent one of the other outcomes listed in this 
definition (examples of such events include allergic bronchospasm requiring intensive treatment 
in the emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse). 
 
 

Unanticipated Problem is defined as an event, experience or outcome that meets all three of 
the following criteria: 
• 
is unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents (such as the IRB-
approved research protocol and informed consent document); and (b) the characteristics 
of the subject population being studied;  AND 
• 
is related or possibly related to participation in the research (possibly related means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); AND 
• 
suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
Unanticipated problems must be reported to the BU IRB using the Reportable Events and New 
Information form.  BU IRB requires that all Unanticipated Problems meeting the definition listed 
above and involving a fatal or life-threatening event be reported to them within 2 days of 
learning of the event. Unanticipated Problems not involving a fatal or life-threatening event must 
be reported to BU IRB within 7 days of learning of the event. 
All Adverse Events and Serious Adverse Events that do NOT qualify as Unanticipated Problems 
must be reported to the BU IRB in section 5 of the Continuing Review submission and include 
the Principal Investigator’s conclusion that the pattern of events does not suggest a greater risk 
of harm. 
Adverse Event Recording from the Baseline Data Collection through Week 6 (in-
person classes) 
Because this study includes older adults at increased risk for falls, we expect adverse events in 
this study to include falls. In addition, we expect adverse events from exercise in both groups to 
include: fatigue, muscle soreness or other discomfort or a fall or injury during tests and exercise. 
As per Lamb 200516, falls will be described as "unexpected events in which the participants 
come to rest on the ground, floor, or lower level." Participants will be provided with the definition 
of falls used in this study in the Baseline Data Collection & Orientation session (prior to starting 
the program). They will be provided with their binders, and we will instruct them in the use of the 
Action plan to record daily any falls or adverse events, symptoms and questions, as they occur.  
At each session, the instructor will collect the forms, make copies for study documentation, and 
return them to the participants. 
 
If participants report fall(s) and/or adverse effects/events through the Action Plan (intervention) 
or Activity Tracker (control), or verbally, in-person or by telephone, the instructor will provide 
appropriate clinical assessment and recommendations and modifications if safe to continue 
participating in the program and document in the clinical flow chart.  In addition, the instructor 
will fill out the Adverse Event Form (Appendix P) and provide the form to the research assistant, 
who will document the event in a master log of all adverse events.  
If a participant falls or experiences an adverse event while attending the class session, the 
instructor will provide appropriate clinical assessment and recommendations and modifications 
if safe to continue participating in the program and document in the clinical flow chart. If injury 
occurred and the participant was unable to participate in the class, the instructor will complete 
and submit an RL Solutions event as per Mt Ascutney procedures. The instructor will determine 

whether the participant needs to seek medical attention at MAHHC and assist the participant to 
the clinic or emergency department.  In addition, the instructor will fill out the Adverse Event 
Form (appendix P) and provide the form to the research assistant for documentation in the 
master log. 
If any adverse event, either self-reported or experienced during class, meets the definition of 
Unanticipated Problem, the instructor will, in addition to providing the Adverse Event Form to the 
research assistant, notify the principal investigator immediately (same day). The principal 
investigator will notify the Boston University IRB within 2 business days if the adverse event 
meets the definition of Unanticipated Problem and involves a fatal or life-threatening event, and 
within 7 days otherwise. All adverse events that do not meet the definition of Unanticipated 
Problem will be reported by the principal investigator to the Boston University IRB at the time of 
continuing review. 
Adverse Event Recording from Week 6 through Study Completion (6 months)  
To identify adverse events after the regular class sessions have been completed, participants 
will record the events in their tracking forms, and a blinded assessor (separate from the 
outcomes assessor, study management and intervention teams) will contact the participants 
every 2 weeks by telephone to inquire about any events that have occurred.  A standard script 
will be followed during these sessions to obtain consistent information and to maintain blinding 
(appendix P).  The blinded assessor will fill out the Adverse Event Form for any event reported 
during a call and provide it to the research assistant for documentation and tracking.  If the 
adverse event meets the definition of Unanticipated Problem, the blinded assessor will also 
notify the principal investigator immediately (same day).  The principal investigator will report the 
Unanticipated Problem according to the BU IRB guidelines stated above.  In addition, other 
study staff will report adverse events if they become aware of them during the post-group class 
time period (Week 6 – 6 Months) by filling out the Adverse Event Form, providing it to the 
research assistant, and notifying the principal investigator immediately if the event is an 
Unanticipated Problem.  
Preliminary Efficacy Data  
Baseline Data Collection (See Appendix R) 
Both  Groups 
Performance-based 
Measures 
Self-report 
4-stage Balance 
demographics 
TUG 
LLFDI community mobility short form 
30-second Chair Stand 
FES-I 
DGI 
ABC-6 
 
Barriers Self-Efficacy  
 
Technology Use Questionnaire 
 
Get up from floor 
 
New/change in health status 
 
Recent fall(s) and mobility questions 
 
Home Assessment Questions 
 

Baseline Data Collection and Orientation  
LIFT Intervention group 
Within 2 weeks of the start of the program, the participants will be invited to come to a baseline 
Data Collection and Program Orientation session. Blinded research staff will provide 
questionnaires, conduct the physical tests, and complete the Baseline Data Collection Form. 
The Intervention and Control groups will be invited to separate Data Collection times or rooms in 
groups of 4. For example, 4 of the Intervention participants will be scheduled for 10:00am on 
Thursday. They will be shown into one room. The blinded research staff (Andrea) will be 
informed of the room and time, but not the assignment of the group. She will inform the 
participants that she must not know their assignment. She will instruct the participants to 
complete the questionnaires, and offer to clarify as needed. While participants are completing 
the questionnaires, she will conduct the TUG, 30 second chair stand, 4-stage balance test and 
Dynamic Gait Index (10 minutes) individually. When participants have completed the 
questionnaires and physical tests, The Data Collector (Andrea) will release them to unblinded 
study staff (Meg), who will bring the participants to the appropriate location for their separate 
orientation sessions. She will also deliver the physical test results to the Intervention group 
instructor (Linda) to inform the Orientation session. The orientation will consist of an explanation 
of the overall structure of the class, provision of the Participant Binder and the activity monitors, 
and ascertaining the starting weight for strength training. Instruction will be provided on use of 
the monitors. Participants will be asked to wear the monitors daily and to record their steps in 
their Action Plan (Appendix B) until the first program session to establish their baseline walking 
activity.  The Action Plan will also be used to track daily symptoms and falls on a daily basis.  
 
Orientation to the Program (see Appendix Q) 
Each participant leaves with his/her assessment form.  
Intervention group meets with Linda who: Completes the Goals Form based on the assessment 
form and patient input. Linda will put copy in binder and make copy for records. Linda will 
document PT progress note with plan of care and goals in medical record (Initial evaluation was 
done by outpatient physical therapist).  
Review program  
Review program goals and baseline assessment results 
Define falls 
Discuss how to handle symptoms, falls.  
Provide the activity monitor, teach use 
Identify if safe for walking program 
Orient to the Activity log; Ask participants to log steps/day, symptoms, falls.  
Review calendar for future data collection, 3 month booster session, 6 month data collection. 
 
Healthy YOUniversity 
The Healthy YOUniversity instructor (Michael) will conduct an orientation that will consist of an 
explanation of the overall structure of the class, the calendar, and provision of the participant 
binder, providing our definition for falls, documentation of their exercise, falls and adverse 
events, and how to contact study staff.  
 
 
Data Collection during the Program 
 
The instructors will record attendance, and copy the Action plans/tracking sheets as record of 
exercise adherence, falls and adverse events. See above for procedures related to Adverse 
events.  

 
6 Week Data Collection Assessment (See Appendix S) 
 
Both Groups 
Intervention Only 
Control Group 
Only 
Performance-
based 
Self-Report 
4-stage Balance 
LLFDI community mobility 
short form or CAT 
 
 
TUG 
FES-I 
 
 
30-second Chair 
Stand 
ABC-6 
 
 
DGI 
Barriers Self-Efficacy  
 
 
 
Get up from floor 
 
 
 
Exercise Adherence: walking, 
strength, balance (from 
Action Plan/Tracking doc) 
6-wk Intervention 
program evaluation 
questions 
6 week Healthy 
YOUniversity 
program 
evaluation 
questions 
 
Falls (from Action 
Plan/Tracking doc) 
 
 
 
Adverse Events (from Action 
Plan/Tracking doc) 
 
 
 
 
3 Month Data Collection (See Appendix T) 
 
Both Groups 
Intervention Only 
Performance-based Measures 
Self-report Measures 
 
4-stage balance 
LLFDI community mobility short 
form or CAT 
 
TUG 
FES-I 
 
30-second Chair Stand 
ABC-6 
 
DGI 
Barriers Self-Efficacy  
 
 
Get up from floor 
 
 
Exercise Adherence: walking, 
strength, balance 
 
 
Falls (from Action Plan) 
 
 
Adverse Events (from Action 
Plan) 
 
 
Falls Questions 
Peer-Coaching Questions 
(Full) 
 
 
 
 

6 Month Data Collection (See Appendix U) 
 
Both Groups 
Intervention Only 
Performance-based Measures 
Self-report Measures 
 
4-stage balance 
LLFDI community mobility short 
form or CAT 
 
TUG 
FES-I 
 
30-second Chair Stand 
ABC-6 
 
DGI 
Barriers Self-Efficacy  
 
 
 
 
 
Get up from floor 
 
 
Steps/Day 
 
 
Exercise Adherence Walking, 
Strength, Balance 
LIFT program overall 
questions 
 
Falls questions 
Peer-Coaching Questions 
(full) 
 

A summary of the program content is provided below. 
 
 
Exercise  
Goal-Achievement 
Week 1 
 
 
Class 1 
Time: 45 min  
15 min 
 
Content: Learn warm up, strength, balance and 
flexibility ex's, overall ex goals (2-3X/week: 2-3 sets 
70% 1 RM; balance challenge, walking 3x/week), 
estimating 70% 1RM; safety, logging activity, 
symptoms, falls 
Group building/Ice-breaker 
activities 
Homework: Look at the 
Action Plan   
Class 2 
45 min  
15 min 
 
Learn warm up, strength, balance and flexibility ex's, 
overall ex goals (3X/week: 1 set of 10  70% 1 RM; 
balance challenge, walking 3x/week), estimating 70% 
1RM; safety, logging activity, symptoms, falls 
Work on Action Plan 
Introduction to Self-
awareness 
Week 2 
 
 
Class 3 
45 min 
 
 
How to progress activity (PT to determine by self-
report of PEI and if able to perform 2 sets of resisted 
exercises progression of weight. Determine safety of 
decreasing support with balance and standing 
exercises.   
15 minutes 
 
 
Problem-solving skills 
 
 
Self-awareness 
 
 
 
Class 4 
45 min Warm up, strengthening exercises, flexibility,  
balance exercises with progression of decreasing 
support 
15 minutes 
 
Ramp/stairs 
Self-Assessment 
 
Introduce methods of transferring safely to floor and up 
with modifications 
 
Week 3 
 
 
Class 5 
30 min Warm up, strengthening exercises, flexibility, 
balance exercises with progression of decreasing 
support. 
15 min Problem-solving  
 
 
15 minutes peer coaching  
 
 
Video; fall-specific coaching; 
roles and responsibilities 
Week 4 
 
 
Class 6 
30 min Encourage participants co-lead exercises. 
Warm up, strengthening exercises, flexibility,  balance 
exercises with progression of decreasing support 
30 min 
 
Set up obstacle course with foam, rocker board, static 
balance challenges, steps, reaching with and without 
UE support 
Peer-coaching skills (active 
listening) 
 
 
Break-out in pairs 
 
 
Report back 
Week 5 
 
 

 
Exercise  
Goal-Achievement 
Class 7 
30 min  Warm up, strengthening exercises, flexibility,  
balance exercises with progression of decreasing 
support 
30 min 
 
Incorporate dynamic balance training including head 
turns, change in gait speed, turning, stepping over 
objects. 
Intro 2 groups of 4 
 
Practice standing to floor transfers as appropriate  
Planning your conversation 
with peers 
 
 
Breakout in 4s; Try it; 
Debrief 
 
 
Method of contact; Schedule 
of calls and facilitator 
Week 6 
 
 
Class 8 
30 min Encourage participant co-lead Warm up, 
strengthening exercises, flexibility, balance exercises 
with progression of decreasing support. Determine 
progression of weights and support for balance 
exercises for final class and progression at home. 
30 min 
 
 
Review how the meeting 
went 
 
 
Self-assessment 
 
 
Peer-coaching 
 
 
Set up goal for 1 month 
Week 12 
30 min Discuss present program; review recent flow 
chart for home exercise program; review exercise 
intensity levels based on the Perceived Exertion 
Rating for each exercise type (e.g. resistance and 
walking). Individual progression and/or modifications 
will be determined by the physical therapist.  
The Goal-Setting program 
lead will facilitate a 
discussion about how goal-
setting and peer-coaching 
activities have been going. 
 
 
 

Statistical Analysis Plan 
 
From grant submission 7-27-2015  
 
Enrollment and safety data will be collected in the study database by the clinical co-
investigators. Safety analyses will be conducted based on similarly basic data collection and 
tracking and will include summary falls, adverse events and protocol deviations, and summary 
statistics (n,%) calculated. This feasibility study will not be powered to detect differences in 
outcomes between the 2 groups. We will carefully examine baseline rates of falls and other 
variables to enable rigorous sample size calculations for a formal clinical trial. However, 
preliminary analyses of changes in the intervention and control groups will be assessed to 
inform study planning. We will calculate the means and standard deviations at pretest (baseline) 
and corresponding values at post-tests (6-week/program completion, 3-month post program, 6-
month post program). The corresponding confidence intervals will be calculated to fully describe 
the plausible true population values.63  We will explore differences between the intervention and 
control group in baseline characteristics, and relationships between these variables and 
outcome variables of interest. Differences between the groups will inform planning for 
randomization and baseline values may be used to adjust for differences in our preliminary 
analyses of differences between groups. At each post-test time point, we will apply analysis of 
covariance (ANCOVA) to examine the relationship between the post-test score and treatment 
controlling for the pretest score and demographic variables.  
 
 
 
 

 
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