Feasibility of a Community-based Exercise Intervention for Persons With Spinal Cord Injury
Phase: NA
Conditions: Spinal Cord Injuries
Sponsor: Washington University School of Medicine

 
 
 
 
 
 
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FEASIBILITY OF A COMMUNITY-BASED EXERCISE INTERVENTION FOR 
PERSONS WITH SPINAL CORD INJURY 
 
NCT03941600 
 
SEPTEMBER 24, 2018 

 
 
 
 
 
 
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Feasibility of a Community-based Exercise Intervention for 
Persons with Spinal Cord Injury 
 
 
Principal Investigator:  Kerri Morgan, PhD, OTR/L, ATP 
 
 
 
 
 
 
 
Version Date/Number: September 24, 2018 
 
 

 
 
 
 
 
 
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TABLE OF CONTENTS 
 
A 
INTRODUCTION .................................................................................................................................. 4 
A1 STUDY ABSTRACT .............................................................................................................................. 4 
A2 PRIMARY HYPOTHESIS ....................................................................................................................... 5 
A3 PURPOSE OF THE STUDY PROTOCOL ................................................................................................... 5 
B 
BACKGROUND .................................................................................................................................... 5 
B1 PRIOR LITERATURE AND STUDIES ...................................................................................................... 5 
B2 RATIONALE FOR THIS STUDY ............................................................................................................. 6 
C 
STUDY OBJECTIVES ............................................................................................................................ 7 
C1 PRIMARY AIM .................................................................................................................................... 7 
C2 SECONDARY AIM ............................................................................................................................... 7 
C3 RATIONALE FOR THE SELECTION OF OUTCOME MEASURES ............................................................... 7 
D 
INVESTIGATIONAL AGENT .................................................................................................................. 8 
D1 PRECLINICAL DATA ........................................................................................................................... 8 
D2 CLINICAL DATA TO DATE .................................................................................................................. 8 
D3 DOSE RATIONALE AND RISK/BENEFITS .............................................................................................. 8 
E 
STUDY DESIGN ................................................................................................................................... 8 
E1 
OVERVIEW OR DESIGN SUMMARY ..................................................................................................... 8 
E2 
SUBJECT SELECTION AND WITHDRAWAL ........................................................................................... 9 
2.a 
Inclusion Criteria ..................................................................................................................... 9 
2.a 
Exclusion Criteria ..................................................................................................................... 9 
2.b 
Ethical Considerations ........................................................................................................... 10 
2.c 
Subject Recruitment Plans and Consent Process ................................................................... 10 
2.d 
Randomization Method and Blinding ..................................................................................... 10 
2.e 
Risks and Benefits ................................................................................................................... 10 
2.f 
Early Withdrawal of Subjects...................................................................................................... 11 
2.g 
When and How to Withdraw Subjects ..................................................................................... 11 
2.h 
Data Collection and Follow-up for Withdrawn Subjects ........................................................ 11 
E3 
STUDY DRUG ................................................................................................................................... 12 
3.a 
Description ............................................................................................................................. 12 
3.b 
Treatment Regimen ................................................................................................................. 12 
3.c 
Method for Assigning Subjects to Treatment Groups ............................................................. 12 
3.d 
Preparation and Administration of Study Drug ...................................................................... 12 
3.e 
Subject Compliance Monitoring ............................................................................................. 12 
3.f 
Prior and Concomitant Therapy ................................................................................................. 12 
3.g 
Packaging ............................................................................................................................... 12 
3.h 
Blinding of Study Drug ........................................................................................................... 12 
F 
STUDY PROCEDURES ........................................................................................................................ 12 
F1 
SCREENING FOR ELIGIBILITY ............................................................................................................ 12 
F2 
SCHEDULE OF MEASUREMENTS ....................................................................................................... 13 
F3 
VISIT 1 ............................................................................................................................................. 13 
F4 
VISIT 2 ETC. ..................................................................................................................................... 15 
F5 
VISIT 3, ETC. .................................................................................................................................... 16 
F6 
SAFETY AND ADVERSE EVENTS ....................................................................................................... 16 
6.a 
Safety and Compliance Monitoring ........................................................................................ 16 
i 
Investigator only ................................................................................................................................... 16 
ii 
Independent expert to monitor ........................................................................................................... 16 
iii 
Institutional Data and Safety Monitoring Board ............................................................................... 16 
iv 
Independent Data and Safety Monitoring Board ............................................................................. 17 

 
 
 
 
 
 
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6.b 
Definitions of Adverse Events ................................................................................................. 17 
6.c 
Classification of Events .......................................................................................................... 17 
i 
Relationship .......................................................................................................................................... 17 
ii 
Severity .................................................................................................................................................. 17 
iii 
Expectedness ....................................................................................................................................... 17 
6.d 
Data Collection Procedures for Adverse Events .................................................................... 17 
6.e 
Reporting Procedures ............................................................................................................. 17 
6.f 
Adverse Event Reporting Period ................................................................................................. 17 
6.g 
Post-study Adverse Event ....................................................................................................... 17 
F7 
STUDY OUTCOME MEASUREMENTS AND ASCERTAINMENT ............................................................. 17 
G 
STATISTICAL PLAN ........................................................................................................................... 18 
G1 SAMPLE SIZE DETERMINATION AND POWER .................................................................................... 18 
G2 INTERIM MONITORING AND EARLY STOPPING ................................................................................. 18 
G3 ANALYSIS PLAN ............................................................................................................................... 18 
G4 STATISTICAL METHODS ................................................................................................................... 18 
G5 MISSING OUTCOME DATA ................................................................................................................ 19 
G6 UNBLINDING PROCEDURES .............................................................................................................. 19 
H 
DATA HANDLING AND RECORD KEEPING ........................................................................................ 19 
H1 CONFIDENTIALITY AND SECURITY ................................................................................................... 19 
H2 TRAINING ......................................................................................................................................... 20 
H3 CASE REPORT FORMS AND SOURCE DOCUMENTS ............................................................................ 20 
H4 RECORDS RETENTION ...................................................................................................................... 20 
H5 PERFORMANCE MONITORING ........................................................................................................... 20 
I 
STUDY MONITORING, AUDITING, AND INSPECTING .......................................................................... 20 
I1 
STUDY MONITORING PLAN .............................................................................................................. 20 
I2 
AUDITING AND INSPECTING ............................................................................................................. 20 
J 
STUDY ADMINISTRATION ................................................................................................................. 20 
J1 
ORGANIZATION AND PARTICIPATING CENTERS ................................................................................ 20 
J2 
FUNDING SOURCE AND CONFLICTS OF INTEREST ............................................................................. 20 
J3 
COMMITTEES .................................................................................................................................... 21 
J4 
SUBJECT STIPENDS OR PAYMENTS ................................................................................................... 21 
J5 
STUDY TIMETABLE .......................................................................................................................... 21 
K 
PUBLICATION PLAN .......................................................................................................................... 21 
L 
ATTACHMENTS ................................................................................................................................ 21 
L1 
TABLES ............................................................................................................................................ 21 
L2 
PATIENT EDUCATION BROCHURES .................................................................................................... 22 
L3 
SPECIAL PROCEDURES PROTOCOLS ................................................................................................... 22 
L4 
QUESTIONNAIRES OR SURVEYS ........................................................................................................ 22 
M 
REFERENCES .................................................................................................................................... 22 
 
A Introduction 
A1 Study Abstract 
Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions 
and poorer health outcomes than persons without spinal cord injury. For PwSCI, habitual 
exercise is critical for both physiological and psychological well-being. Prior research 
indicates that exercise programs conducted in a controlled setting have positive effects 
on the physical and psychosocial fitness of PwSCI, but the efficacy and feasibility of 
these programs are not well understood in community-based settings. PwSCI will be 
randomized to a 12-week community-based exercise intervention (CBEI; n = 20) or an 
exercise education control group (EEG; n = 20). The proposed project aims to examine 

 
 
 
 
 
 
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potential health benefits in response to the intervention and identify the barriers and 
facilitators to successful implementation of a CBEI in PwSCI (N = 40). 
A2 Primary Hypothesis 
The community-based exercise group (CBEI) will have a 10% improvement in peak 
oxygen consumption (VO2peak), upper extremity strength, body fat, cardiovascular risk 
profile (fasting plasma HDL cholesterol, triglycerides, and insulin resistance), and 
psychological well-being (sleep, pain, fatigue, and depression) as compared to the 
exercise education control group (EEG) post-intervention.  
A3 Purpose of the Study Protocol 
The purpose of the study is to examine the impact of a community-based exercise 
intervention for persons with spinal cord injury on physiological and psychological well-
being and identify barriers and facilitators to implementation.  
B Background 
B1 Prior Literature and Studies 
 
Background:  
SCI and exercise: Approximately 285,000 people in the US are living with an SCI.1 
PwSCI are at a greater risk for heart disease, high blood pressure, obesity, and diabetes 
than those without disabilities.2-4 SCIs often result in various physiological alterations 
affecting multiple body systems, including blunted hemodynamics, altered sympathetic 
innervation, altered glycemic control, reduced active muscle mass, deteriorated 
circulatory vessels below level of injury, and impaired arterial compliance and function.5 
These pathophysiological alterations amplify the risk and prevalence of cardiovascular 
and metabolic diseases in PwSCI,6-7 suggesting a great need for increased physical 
activity and fitness in this population. The typical daily routine of PwSCI does not stress 
the cardiorespiratory system enough to produce positive health-related changes; 
therefore, structured exercise activities are needed to enhance physical capacity and to 
reduce the likelihood of secondary complications.8-10 Increased cardiorespiratory fitness 
in PwSCI promotes not only improved functional independence, but also improved 
cardiovascular and metabolic health.7,11 
Exercise recommendations and barriers: Despite the widely recognized health 
benefits of regular physical activity,12 PwSCI report the lowest levels of physical activity 
compared to other populations,13-14 with fewer than 50% engaging in any physical 
activity, and only 15% engaging in physical activity sufficient to gain meaningful health 
benefits.14-15 The most recent evidence-based exercise guideline for PwSCI recommends 
engagement in at least 30 minutes of moderate-to-vigorous-intensity aerobic exercise 
three times per week to achieve cardio-metabolic health benefits.16 Because of 
decreased sympathetic innervation, muscle atrophy, and decreased cardiac reserves, it 
is difficult for PwSCI to achieve these intensity levels without proper support.12,17 There is 
a considerable lack of accessible facilities, equipment, and support for PwSCI outside of 
rehabilitation,18,22-25 and PwSCI also often lack knowledge of the types of exercise that 
will allow them to be successful in exercise. Typical exercise facilities (e.g., YMCA, 24 
Hour Fitness) generally do not provide the types of support necessary for PwSCI to 
successfully exercise.24,26 More evidence is needed to identify effective exercise 

 
 
 
 
 
 
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interventions implemented outside of the rehabilitation setting that improve health for 
PwSCI.27 
 
Preliminary Work: We have conducted two related studies that support this proposed 
project. The first was a single-arm design that assessed 284 PwD (63 PwSCI) who 
joined the Paraquad Health and Wellness Center (PQHWC), an accessible gym with 
equipment and staff to support PwD. Participants were encouraged to work on strength 
and endurance exercises but were not monitored. We compared participants’ weight, 
BMI, pain, endurance, and strength pre- and post- 12 weeks of participation in the 
PQHWC. Total group results showed significantly decreased average pain reported over 
the past 30 days and significant increases in four upper extremity strength exercises (p < 
.05). No changes in body weight, BMI, or endurance were found. Limitations of this study 
were the lack of control group for comparisons, lack of rigorous assessments to identify 
changes at the cardiorespiratory or metabolic levels, and lack of structure to adequately 
meet the physical activity guidelines for PwSCI.28-29, 
 
The second study was qualitative and involved interviews of seven active participants in 
the PQHWC and six staff members,30 the purpose of which was to gather participant and 
staff perspectives about the impact of the program and suggestions for evaluation. 
Participants identified knowledgeable staff, options for adapted exercise equipment, and 
a positive social environment as critical program components. However, participants 
reported that although the supports were in place to exercise, their knowledge about 
how they should exercise was limited. Staff expressed the need for sound measures to 
identify whether participants were making changes. These two studies identified 
weaknesses of a community-based exercise program and the need for an exercise 
intervention that provides structure and education for PwSCI. Through the information 
learned in these studies, we developed the structured, 12-week CBEI proposed in this 
application. 
B2 Rationale for this Study 
Although a wealth of evidence exists regarding the benefits of exercise interventions for 
PwSCI, there is limited research on exercise interventions that are community-based 
and follow the recommend guidlelines.31-32 Previous studies of community-based 
exercise programs have varied widely in their populations of focus, research designs, 
exercise protocols, and health outcomes. Many of these studies lack the rigorous 
designs, sample sizes, and testing needed to examine the effects of exercise on key 
health outcomes.31,33 As a result, there is extensive variability in evaluation methods 
among published studies.31,34 Additionally, metabolic measures are not often included in 
studies based in the community. The proposed research is innovative because it 
addresses factors that often impede successful implementation of exercise for PwSCI in 
the community, follows the recommended guidelines, and uses sound measures. 
 
Cardiorespiratory-related diseases account for approximately 40% of mortality as the 
leading cause of death for PwSCI.1, 35-36 For PwSCI, the decline in physical capacity and 
increased risk of secondary health conditions often result in reduced independence and 
participation in life activities. About 30% of PwSCI are re-hospitalized one or more times 
any given year following injury, with an average length of stay of 22 days.37 PwSCI who 
are physically active tend to make fewer visits to physicians and experience fewer 
medical complications and hospitalizations than their sedentary counterparts.38 
Participating in recommended amounts of exercise may offer an effective method for 

 
 
 
 
 
 
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increasing cardiovascular fitness and metabolic health in PwSCI.10 Therefore, it is 
imperative to build supports and resources outside of rehabilitation to promote health 
and well-being to improve physiological and psychosocial outcomes experienced by 
PwSCI. The significance of this project is its focus on a CBEI that uses accessible 
equipment and health professionals to implement multi-modal exercise programs that 
are individualized to each participant’s needs and meet recommended guidelines. This 
study has the potential to establish a community-based model to be emulated in other 
settings. 
C Study Objectives 
C1 Primary Aim 
Primary Aim: To estimate improvements in physical function, cardio-metabolic 
health, and psychological well-being of participants enrolled in a CBEI compared 
to an education-only control group. 
Forty PwSCI will be randomized into either the CBEI group or the EEG receiving 
education only. We will measure physical function (cardiorespiratory fitness and 
strength), cardio-metabolic health (body composition, glucose tolerance, and 
cardiovascular risk profile), and psychological well-being (PROMIS). We hypothesize 
that the CBEI will have a 10% improvement in peak oxygen consumption (VO2peak), 
upper extremity strength, body fat, cardiovascular risk profile (fasting plasma HDL 
cholesterol, triglycerides, and insulin resistance), and psychological well-being (sleep, 
pain, fatigue, and depression) as compared to the EEG post-intervention. 
C2 Secondary Aim 
Secondary Aim: To identify barriers, facilitators, and reasons for positive 
determinants for PwSCI to exercise in a community-based setting.  
We will use a mixed methods approach to characterize key implementation outcomes: 
acceptability, feasibility, and fidelity. Information will be gathered during the intervention 
using activity monitors, heart rate monitors, and rating scales to identify whether 
exercise intensity rates were met. Participants will be interviewed for the purposes of 
comparing the experience of participants who experienced change and those who did 
not. This information will enable us to determine the degree to which the pilot 
intervention’s success or failure was related to implementation outcomes and to inform 
the development of a future R01-funded clinical trial. We hypothesize that the 
intervention will be accepted among PwSCI, feasible to implement, and that delivery of 
the intervention will adhere to the exercise intervention protocol (fidelity). 
C3 Rationale for the Selection of Outcome Measures 
The primary outcome variables for this randomized controlled trial (RCT) include: 
cardiorespiratory fitness (VO2peak and 6-minute push test), pain (Wong-Baker FACES), 
metabolic health (blood chemistries), body composition (dual-energy x-ray 
absorptiometry [DXA] scan, height, weight, BMI), vitals (heart rate and blood pressure), 
and psychosocial well-being (PROMIS-29 Profile). These variables are significantly 
impacted by physically inactive lifestyles, which are highly common among manual 
wheelchair users (MWUs) with SCI. MWUs with SCI also exhibit and report values of 
some of these variables below healthy range, potentially impacting physiological health 
and psychosocial well-being and overall quality of life. Secondary outcome variables 

 
 
 
 
 
 
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include qualitative perspectives of the research staff delivering the exercise intervention 
and of participants to assess the feasibility of the intervention protocol. 
 
D Investigational Agent  
Not applicable 
D1 Preclinical Data 
Not applicable 
D2 Clinical Data to Date  
Not applicable 
D3 Dose Rationale and Risk/Benefits  
Not applicable 
E Study Design  
E1 Overview or Design Summary 
The proposed project utilizes a mixed-methods approach. An experimental strategy 
using an RCT (single-blinded) will be used. Forty participants (n = 40) will be randomized 
into the CBEI (n = 20) or the EEG (n = 20) by a research staff member who will not be 
involved in either conducting outcome assessments or implementation of the 
intervention. This design will assist in reducing variability and maximizing the effect size 
for powering a subsequent larger RCT.  
 
The intervention for participants in the CBEI will consist of one-on-one, formally directed 
exercise sessions by trained staff in the PQHWC. The CBEI is based on the recent 
evidence-based exercise guideline for PwSCI,14 American College of Sports Medicine’s 
(ACSM) Physical Activity Recommendations for PwSCI,29 best available evidence,39-41 
and preliminary work.30 The intervention will include 36 60–90-minute sessions over 12 
weeks (three sessions/week) with a goal of participants guiding their own exercise 
regimens by the end of the intervention. Personalized exercise sessions will be created 
for each participant based on fitness goal(s), preferred exercise equipment, and results 
from their initial assessment. Participants will be educated on how equipment works and 
what exercises are appropriate, and will be guided on intensity levels. At the beginning 
of each session, vitals and pain42 will be assessed, and each participant will complete a 
minimum 5-minute warm-up. After the warm-up, each participant will complete 
cardiovascular training in bouts of at least 10 minutes. Staff will monitor the sessions to 
ensure that participants perform at least 30 minutes three times a week of moderate-to-
vigorous exercise,16,29 as determined by a report of 12 or higher on the Borg’s Rate of 
Perceived Exertion (RPE) Scale (6–20).43-44 Due to altered sympathetic innervation in 
PwSCI,5 target heart rate may not be reliable; therefore, RPE will be the real-time 
determinate of intensity. Activity monitors (GT9X Actigraph, Pensacola, FL) will be 
donned to capture intensity data to be processed post hoc. Each participant will then 
complete a 3–5-minute cool-down. After cardiovascular training, each participant will 
complete strength training geared toward their goals, with guidance from PQHWC staff 

 
 
 
 
 
 
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to perform a comprehensive variety of strength exercises to promote fat-free mass, 
muscle endurance, and overall strength. Staff will set up and monitor strength training to 
ensure that, for each exercise, participants perform at least two to three sets of 10–15 
repetitions (reps) at 50%–75% one-rep max (1RM) for each exercise targeting 
functioning muscle groups.16,29 After strength training, participants will complete a 5–10 
minute cool-down, and final heart rate, blood pressure, and pain will be assessed. Staff 
are occupational therapists and physical therapy assistants who have worked in an 
exercise setting with PwSCI. Staff will be taught the exercise guidelines16,29 and exercise 
session protocols using written materials, demonstration, and practice sessions. 
Following each exercise intervention session, participants will describe what they liked 
and did not like, provide a rating (1–5) of how much they gained from the session, and 
answer an open-ended item requesting suggestions for improvement. At the end of each 
session, the trainer will rate the participant’s perceived participation during the session 
(1–6) using the Pittsburgh Rehabilitation Participation Scale.45 
 
The participants in the EEG will complete an intervention that consists of a one-on-one, 
hour-long educational session orienting participants to an online resource center, the 
National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD 
promotes health and well-being for PwD through resources such as adapted exercise 
videos, information on accessible fitness equipment, personalized exercise videos 
tailored to PwD, and an individualized 14-week exercise program. Participants will be 
given an overview of NCHPAD and asked to identify resources of interest on the 
website. Each participant will be asked to use resources on NCHPAD to engage in 
physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire 
about their physical activity, exercises engaged in, RPE during exercise, and whether 
any resources were used. 
E2 Subject Selection and Withdrawal  
2.a 
Inclusion Criteria  
1) Diagnosis of SCI  
2) 18 years or older 
3) Have written physician approval to participate in the study 
4) Ability to use upper extremities to exercise 
5) Participate in < 60 minutes of moderate-intensity exercise per week in the last  
month 
7) Understand English at a sixth-grade level or higher 
8) Be able to follow multi-step instructions 
9) Independently provide informed consent 
10) Willing to participate in three assessments and 36 intervention sessions 
 
2.a 
Exclusion Criteria  
1) Enrollment in a structured exercise program in the past six months.   
2) Have had cardiovascular complications within the past year 
3) Currently receive medical treatment for an acute upper extremity injury 
4) Have a Stage IV pressure injury 
5) Have a cognitive impairment that does not allow them to provide consent or 
follow multi-step directions. 

 
 
 
 
 
 
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2.b 
Ethical Considerations  
Physical activity in healthy individuals and in people with varying pathologies is 
beneficial for physiological and psychological health and well-being, and these benefits 
are expected in people with SCI. Our previous studies have also shown that physical 
activity is safe and realistic for persons with SCI. There are no obvious ethical 
considerations. 
2.c 
Subject Recruitment Plans and Consent Process 
Potential participants may either be approached or identified by the PI from Paraquad’s 
waiting list, or potential participants may contact us after viewing a study flyer posted 
within community and rehabilitation facilities. The study coordinator may describe the 
study with participants over the telephone or in person and, if they are interested, verbal 
consent will be obtained to continue with the screening document. This process will be 
the same for all populations, as the randomization does not occur until after the first 
assessment is completed. After the screening document is complete, the study 
coordinator will obtain medical referrals from the participant’s physician(s); once 
permission from the participant’s physician(s) is received, the participant will be 
contacted via phone by the study coordinator and scheduled for their first assessment 
appointment. Prior to the scheduled initial assessment, a copy of the written consent 
form may be mailed to the potential participants so they may have time to review it, 
become familiar with it, and prepare any questions they may have. The study 
coordinator may also contact potential participants via phone 24–72 hours prior to their 
scheduled initial assessment to remind potential participants of their upcoming initial 
assessment appointment. Upon arriving to their first assessment appointment, a 
research staff member will review the written consent form with the potential participant. 
Potential participants will be given time to review the form additionally on their own, 
discuss with family members if they wish, and have any and all questions addressed. 
Potential participants will then be asked to initial, sign, and date the form, as necessary, 
prior to participating further in the initial assessment. 
2.d 
Randomization Method and Blinding 
Randomization does not occur until after the initial assessment is completed. 
Immediately following completion of the initial assessment, each participant will be 
randomly assigned to either the CBEI (n = 20) or EEG (n = 20). To control for selection 
bias, stratified randomization will be used to ensure that the CBEI and EEG are 
balanced with respect to how long the participant has been injured (<2 years or ≥2 
years), the participant’s level of injury (below C7 or C7 and above), age (<40 years or 
≥40 years of age), and gender. This will control for a large imbalance of participants 
allocated to one intervention. Research staff performing the assessments will be blinded 
to group randomization.  
2.e 
Risks and Benefits 
Risks: 
A likely or common mild risk that may occur from participating in the testing sessions 
and/or participating in any exercise program for 12 weeks is that participants may 
experience muscle soreness or fatigue. Participants will have planned rest breaks, be 
allotted any unplanned rest breaks requested, and be encouraged to maintain hydration 
levels during exercise training. There is also a mild risk of emotional distress or 
discomfort in completing the questionnaires. Participants will complete questionnaires in 

 
 
 
 
 
 
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a private area and will be allowed to decline to answer any of the questions that make 
them uncomfortable. 
An uncommon risk that may occur is an exercise-related injury, such as muscle 
strain or sprain. To help ensure that participants are safe to exercise, they will be 
required to have a physician’s referral to participate in this study; in addition, a heart rate 
monitor and accelerometers will be worn during selected testing and exercise sessions 
(if assigned to the CBEI) to ensure accurate monitoring of their health status. They will 
also be educated about the proper and safe way to exercise before the study begins. For 
CBEI participants, trained research members will be present during all sessions to 
ensure participant safety. Proper precautions to avoid injury, including stretching and 
rest breaks, will be employed to reduce the risk of soft tissue damage.  
Another risk to participants includes potentially dangerous conditions associated 
with SCI, such as autonomic dysreflexia, during assessments and exercise training. 
However, this is a very small risk. All research team members are familiar with serious 
conditions, such as autonomic dysreflexia, and medical precautions to monitor any life-
threatening conditions will be taken during testing and training. In the highly unlikely 
event a participant experiences a medical emergency, immediate appropriate actions will 
be taken by research staff.  
 
Benefits: 
Participants may or may not benefit from being in this study. Participants may directly 
benefit by:  
 
Increasing their ability to exercise and function in the community 
 
Improving their cardiorespiratory and metabolic function 
 
Improving their psychological well-being 
 
Increasing their physical fitness 
 
Receiving new and valuable information about exercise recommendations and 
their health 
2.f 
Early Withdrawal of Subjects  
Participants (CBEI or EEG) will be withdrawn if they are non-compliant with the exercise 
program specific to their group assignment (miss >30% of visits in a particular month) or 
if they experience a medical complication that prohibits exercise. 
2.g 
When and How to Withdraw Subjects  
The research coordinator of the study is primarily responsible for scheduling testing and 
exercise sessions for participants. The research coordinator will also be in weekly 
contact with designated PQHWC staff to update the research team  on the 
attendance/compliance of  CBEI participants. If deemed that a participant is non-
compliant with the exercise program protocol, the research coordinator will contact the 
participant and inform him/her of the withdraw policy. If the participant remains non-
compliant over the following two weeks, he/she will be withdrawn by the research team 
and will be contacted via phone.  
2.h 
Data Collection and Follow-up for Withdrawn Subjects  
Whether participants withdraw voluntarily or are withdrawn by research staff, they may 
be asked to complete a close-out visit (in-person or on the phone) to provide the 
research team with feedback regarding why they decided to leave the study early/not 
comply with the program. 

 
 
 
 
 
 
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As this is a pilot RCT, if a participant is withdrawn, initial assessment data will be 
evaluated; however, no follow-up assessment will be conducted. 
E3 Study Drug  
The proposed study is not a drug-trial intervention, but rather an exercise intervention 
using a developed community-based exercise intervention program. 
3.a 
Description  
Not applicable, this is not a drug study. 
3.b 
Treatment Regimen  
Not applicable, this is not a drug study. 
3.c 
Method for Assigning Subjects to Treatment Groups  
Not applicable, this is not a drug study 
3.d 
Preparation and Administration of Study Drug  
Not applicable, this is not a drug study 
3.e 
Subject Compliance Monitoring  
Not applicable, this is not a drug study 
3.f 
Prior and Concomitant Therapy  
Not applicable, this is not a drug study 
3.g 
Packaging  
Not applicable, this is not a drug study 
3.h 
Blinding of Study Drug  
Not applicable, this is not a drug study 
F Study Procedures  
F1 Screening for Eligibility 
Potential participants may either be approached or identified by the PI from Paraquad’s 
waiting list; potential participants may also contact us after viewing a study flyer posted 
within community and rehabilitation facilities. The study coordinator may describe the 
study with participants over the telephone or in person and, if they are interested, verbal 
consent will be obtained to continue with the screening document. This process will be 
the same for all populations, as the randomization does not occur until after the first 
assessment is completed. After the screening document is complete, the study 
coordinator will obtain medical referrals from the participant’s physician(s); once 
permission from the participant’s physician(s) is received, the participant will be 
contacted via phone by the study coordinator and scheduled for their first assessment 
appointment.  

 
 
 
 
 
 
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13
F2 Schedule of Measurements 
The research coordinator will primarily schedule all initial and post-assessments with 
participants over the phone once participants are deemed eligible for participation. Prior 
to the scheduled initial assessment, a copy of the written consent form may be mailed to 
the potential participants so they may have time to review it, become familiar with it, and 
prepare any questions they may have. The research coordinator may also contact 
potential participants via phone 24–72 hours prior to their scheduled initial assessment 
to remind potential participants of their upcoming initial assessment appointment.   
F3 Visit 1  
Upon arriving to their first assessment appointment, a research staff member will review 
the written consent form with the potential participant. Potential participants will be given 
time to review the form additionally on their own, discuss with family members if they 
wish, and have any and all questions addressed. Potential participants will then be 
asked to initial, sign, and date the form, as necessary, prior to participating further in the 
initial assessment. Once written consent is obtained, all participants will complete the 
initial assessment.  
 
The initial assessment (T1) will be completed over two separate days, with the second 
day (D2) being completed within 10 days of the first assessment day (D1).  
 
Procedures for Day 1 of Initial Assessment (T1D1): 
T1D1 (90–120 minutes) will be completed at Washington University’s EMC research 
laboratory, located within the Paraquad Health and Wellness Center building. During this 
appointment, participants will complete many self-report measures. These measures will 
assess: demographics (CORE), psychosocial factors (PROMIS–fatigue, depression, 
pain, sleep, and emotional support), physical activity (LTPAQA-SCI, ESES, and RM-4), 
and community participation (CPI). Participants will also be asked to perform functional 
mobility (6MPT), strength testing (BTE and Equalizer), and a cardiovascular fitness test 
(VO2peak). Resting blood pressure and heart rate, height, weight, and body mass index 
will also be measured on T1D1. The participants may be asked to wear a heart rate 
monitor and accelerometers to measure their intensity levels during testing.  
 
Self-Report Assessments: 
Characteristics of Respondents (CORE): The following data will be collected via 
the CORE: demographics (age, gender, race, employment status, and highest level of 
education completed), diagnosis, neurological level of injury, time since onset of injury, 
general health status, secondary health conditions, medications, and mobility device 
used.17  
PROMIS Measures: The PROMIS measures will be used to assess six different 
domains: emotional distress, emotional support, sleep, pain interference, pain intensity, 
and fatigue. Individuals respond to the items in each domain using a five-point Likert 
scale. The six domains are scored individually. 
 
Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI): 
The LTPAQ-SCI is a self-report measure of leisure time physical activity that assesses 
minutes of mild, moderate, and heavy intensity activity over the previous seven days. 
The survey will be collected during screening to determine eligibility.  
 
The SCI Exercise Self-Efficacy Scale (ESES): The ESES is a 10-item, SCI- 

 
 
 
 
 
 
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14
specific scale developed to measure perceived exercise self-efficacy for various types of 
physical activities. The scale requires individuals to self-report their confidence in 
performing physical activities and exercise. One dichotomous item asks whether the 
individual has exercised at home and/or in a gym in the past 12 months. Individuals 
respond to the 10 items using a four-point Likert scale (1: not at all true, 4: always true); 
the total score is then derived by summing the scores for the individual items; scores 
range from 10 to 40. Higher scores indicate greater perceived self-efficacy. The 
dichotomous item is used to estimate the participant’s average exercise activity.  
 
Community Participation Index (CPI): The CPI is a valid and reliable assessment 
of involvement in life situations and individual control over participation.46-47 For each 
item, respondents rate frequency (either in days, hours, or times per week, depending 
on the activity), whether it was important (yes/no), and to what extent they do the item 
(too much, enough, or not enough). The measure is used as a categorical variable using 
validated scores. Participation will be assessed at baseline and both follow-up 
assessments to determine the level of change in participation for each MWU with SCI.  
 
RM 4-FM: Motivation for Physical Activity and Exercise/Working Out: This 
questionnaire is designed to assess whether the participants are extrinsically or 
intrinsically motivated to engage in a physical activity. The questionnaire makes a 
statement of “I try, or would like to try, to be physical active regularly,” and participants 
must rate themselves on a Likert scale between 1 (not true at all), to 7 (very true). 
 
 
Physical Assessments:  
VO2peak: Measured using a standard computer-integrated, open-circuit, breath-
by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy, UT, 
US) while the participant performs a graded-exercise test on an arm crank ergometer 
(ACE), (SCIFIT PRO2,  Life Fitness, Tulsa, OK, US). In addition, an H7 Heart Rate 
Sensor (Polar Electro Inc., Lake Success, NY, US) will be placed on each participant to 
monitor heart rate during testing. Each participant will be fitted with a silicone mask to 
cover his or her mouth and nose while performing the exercise test, which is typically 
completed in 8–12 minutes depending on the participant’s fitness level.8 The protocol 
involves a 3-minute warm-up at a workload of 8–10 watts (W) followed by a standard 
ACE ramp protocol. The ramp protocol requires participants to maintain 60 revolutions 
per minute (rpm) with incremental increases by 7 W every minute, until exhaustion.  
 
Muscle Strength: The participants’ muscle strength will be tested using Equalizer 
accessible exercise equipment to establish their one-repetition maximum (1-RM) on four 
upper-body exercises tested on each arm (left and right arm bicep curls, left and right 
arm chest press, left and right arm rowing, and left and right arm rickshaw triceps 
extension). Each exercise represents a different motion (pushing or pulling) in varying 
planes. For example, the rickshaw exercise involves pushing downward on straps 
connected to weights. Upon completion of one repetition during the strength 
assessment, the participants will report their arm movements as easy, moderate, or 
hard. The greatest amount of weight lifted for the complete range of motion for the lift will 
be recorded as the 1-RM. This will be used in determining the exercise routine for 
participants enrolled in the exercise intervention. 
 
The 6-minute Push Test (6MPT): The 6MPT is a functional mobility and physical 
fitness test involving MWUs propelling a designated 30-meter loop. Participants are 

 
 
 
 
 
 
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15
asked to propel as far as possible on the course within 6 minutes. Total distance 
propelled is determined by tallying the number of completed 30-meter loops and 
measuring the partially completed final lap using a tape measure.22  
 
Anthropometrics and Vitals: Body mass will be measured by height, weight 
(using a wheelchair accessible scale), and BMI. Resting and post-testing blood pressure 
and heart rate will also be taken at each testing session.  
 
Qualitative Data: After completion of the 12-week sessions, participants will complete  
a 60-minute, semi-structured interview. Interviews will be conducted by applying general 
rules for qualitative research interviews.48-50 A protocol for facilitating interviews will be 
developed with specific key questions. A sample question is, “Did this community-based 
exercise intervention support your ability to participate in a regular exercise routine?” 
Interviews will be recorded, and notes will be taken to assist in identifying main themes. 
 
 
Procedures at for Day 2 of Initial Assessment (T1D2): 
T1D2 (60 minutes) will be completed at the Center for Applied Research Sciences 
(CARS) Clinical Research Unit (CRU), which is established within the Institute of Clinical 
and Translational Sciences. T1D2 will consist of a blood draw (metabolic blood 
chemistries) and a DXA body scan (body composition). Prior to D2, participants will be 
instructed to fast the night before (8–10 hours). Trained CARS staff will conduct blood 
draws and DEXA scans and assist participants, as needed, during T1D2. Research staff 
may also be present during T1D2 at CARS to assist participants, as needed. 
 
Body Composition:  
Body compostion will be quantified by DXA (General Electric Lunar iDXA) located at the 
WUSM CRU. DXA is commonly used in research due to its precision and safety. Bone 
mineral density and whole-body, regional fat, and fat-free (i.e., lean) mass in kg and % 
will be calculated. Appendicular skeletal muscle mass will be estimated from these data 
as described and validated by Heymsfield et al.51  
 
Metabolic Blood Chemistries:  
Fasting blood values will be obtained for markers of inflammation (hsCRP), insulin 
resistance (HOMA-IR using fasting glucose and insulin concentrations), complete blood 
cell counts (CBC), fasting lipid/lipoproteins (triglycerides, total-, LDL-, HDL-cholesterol), 
and glycosylated hemoglobin (a marker of glycemic control) at T1 and T2. To explore 
neurogenesis mechanisms, we will quantify plasma BDNF, IGF-1, and VEGF using 
ELISA kits (R&D Systems, Minneapolis, MN).52-54 Participants will be instructed to fast 
the night before (8–10 hours). Upon arrival to the CRU after the overnight fast, blood will 
be collected from the antecubital vein. Blood will be collected with preservatives and 
stored in Dr. Todd Cade’s laboratory located in 1750 West Building on the Washington 
University School of Medicine Campus. Serum and plasma will be aliquoted into 
individual vials and frozen (−80o C) until all participants have completed the study 
intervention. 
F4 Visit 2 etc.  
All participants will complete a 12-week post-assessment within 10 days of completing 
their final intervention session, either CBEI or EEG. The post-assessment (T2) will also 
be completed over two separate days with the second day (D2) being completed within 

 
 
 
 
 
 
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16
10 days of the first assessment day (D1). T2D1 (120 minutes) and T2D2 (60 minutes) 
will be the same as the initial assessment (T1). In addition, at the T2D1 appointment, 
participants will complete a 30-minute, semi-structured qualitative interview regarding 
their experiences while participating in the study. The participants may also be asked to 
wear a heart rate monitor and accelerometers to measure their intensity levels during 
testing. T2D1 will take place at the EMC research laboratory, and T2D2 will be 
completed at the CARS CRU. 
F5 Visit 3, etc.  
Participants may complete a three-month post-assessment. The post-assessment (T3) 
will also be completed over one day. T3D1 (90 minutes) will be the same as the initial 
assessment (T1). The participants may also be asked to wear a heart rate monitor and 
accelerometers to measure their intensity levels during testing. T3D1 will take place at 
the EMC research laboratory. 
F6 Safety and Adverse Events  
6.a 
Safety and Compliance Monitoring 
The research coordinator is the primary scheduler for initial and post-assessments and 
CBEI exercise sessions; therefore, she will daily monitor assessments and CBEI safety, 
compliance, and progress. The research coordinator will also be in weekly contact with 
designated PQHWC staff to update the research team on the safety and compliance of 
EEG participants.  
 
Medical Monitoring: 
There will be a physican who will provide medical monitoring of the body composition 
and metabolic blood chemistry appointments. 
i 
Investigator only 
 
ii 
Independent expert to monitor 
Not applicable 
iii 
Institutional Data and Safety Monitoring Board 
To ensure that participants are medically stable and safe to participate in the project, 
physician’s approval and a signed release will be required prior to the initial assessment. 
During assessment and exercise sessions, participants will be monitored for safety, pain, 
and any signs of distress. Heart rate monitors will be worn during the VO2 testing. Blood 
pressure will be taken at the beginning of all testing and intervention sessions. If a 
participant reports an 8/10 pain level prior to a session, the session will be canceled and 
rescheduled. If at the end of a session the participant reports pain 8/10 or higher, the 
rating will be documented in the study’s adverse event tracking log. Participants may be 
dismissed from participation if they rate pain 8/10 or higher over three consecutive 
sessions. Trained research investigators will be present during all sessions to ensure 
participant safety. If a participant is uncomfortable with having their blood drawn for 
metabolic testing, they may choose to skip that portion and still continue within the study. 
All members of the research team are familiar with potentially dangerous conditions 
associated with SCI, such as autonomic dysreflexia, and will take appropriate actions if a 

 
 
 
 
 
 
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17
participant experiences a medical emergency. Adverse events will be reported to the 
IRB consistent with the IRB’s reporting guidelines. We will take every precaution to 
ensure participant safety while avoiding risks.  
Safeguarding of data: Researchers will assign participants a code to de-identify 
all data according to HIPAA policies. Data will be stored in a password-protected 
computer to guarantee participant privacy. To ensure quality of data collection, a 
research member will oversee each piece of equipment (i.e., Metabolic cart, heart rate 
monitor, and accelerometers) for immediate detection of technological malfunctions 
during sessions. 
iv 
Independent Data and Safety Monitoring Board 
Not applicable 
6.b 
Definitions of Adverse Events 
An adverse event will be defined as a musculoskeletal injury, episode of autonomic 
dysreflexia, or other medical event that is the result of the assessments or exercise 
training program. 
6.c 
Classification of Events 
 
i 
Relationship 
 
ii 
Severity 
Any event that requires medical care will be defined as an adverse event. 
iii 
Expectedness 
Adverse events are not expected as a result of the intervention. 
 
6.d 
Data Collection Procedures for Adverse Events 
Adverse events will be recorded in an adverse event tracking log and reported in 
publications resulting from data. 
6.e 
Reporting Procedures 
Adverse events will be reported to the IRB consistent with the IRB’s reporting guidelines 
and will be reported to the National Institutes of Health upon annual progress reports.  
6.f 
Adverse Event Reporting Period 
Consistent with the IRB’s reporting guidelines. 
6.g 
Post-study Adverse Event 
All adverse events will be examined at the completion of the study. 
F7 Study Outcome Measurements and Ascertainment 
 

 
 
 
 
 
 
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18
G Statistical Plan  
 
G1  Sample Size Determination and Power 
This is a pilot study, with our primary interests in outcome variability and co-variability 
and estimates of feasibility and acceptability, which will aid in the planning of a larger 
trial. The sample size of 40 participants was selected to provide enough participants to 
assess the research protocol, determine trends in change, and provide data to calculate 
sample sizes for a larger RCT. 
G2  Interim Monitoring and Early Stopping 
The research coordinator is the primary scheduler for initial and post-assessments and 
CBEI sessions; therefore, she will daily monitor assessments and CBEI safety, 
compliance, and progress/stopping. The research coordinator will also be in weekly 
contact with designated PQHWC staff to update the research team on the safety and 
compliance of CBEI participants. Designated PQHWC staff will be present to supervise 
all CBEI participants to monitor safety. 
G3  Analysis Plan 
The proposed project utilizes a mixed method approach. The Primary Aim is an 
experimental strategy using an RCT method to estimate improvements in physical 
function, cardio-metabolic health, and psychological well-being of participants enrolled in 
a community-based exercise intervention compared to an education-only control group 
on people with SCI. This is a pilot study with the purpose of determining the feasibility of 
implementing an RCT intervention and developing methodology together with protocols 
for a larger study with longer-term follow-up assessments. The proposed project utilizes 
a mixed methods approach, with the Secondary Aim being both quantitative and 
qualitative in nature to evaluate the feasibility of the intervention and evaluate the 
methods of delivery from the perspective of the research staff conducting and monitoring 
exercise sessions and the participants regarding the enrollment, assessment, and 
acceptance, adherence, and tolerance of the intervention protocol.  
G4  Statistical Methods  
Aim 1: Data will be collected and managed using Research Electronic Data Capture 
(REDCap) and exported to SPSS for analysis. Descriptive statistics will be used to 
describe the CBEI and the EEG. The data will be examined for normality, outliers, and 
errors. To examine whether the datasets meet the assumptions of normality, a Shapiro-
Wilks test will be conducted. The assumptions of homogeneity of variance and 
homogeneity of covariance will be examined with Box’s M and Mauchly’s W tests, 
respectively. To examine the presence of outliers, histograms will be used. The purpose 
of the analysis is to compare the post VO2peak measures (primary outcome) between 
the two groups. First, a two sample t test (or non-parametric Wilcoxon test) will be used 
for unadjusted analyses. Then we will use a linear regression to compare VO2peak 
between the CBEI and EEG, adjusting for pre-VO2peak measures and other potential 
covariates. For other outcomes, based on the measurement scale, a similar analysis 
approach (unadjusted and adjusted) will be used. For binary outcomes, a Pearson Chi-
square or fisher exact test will be used for unadjusted analyses, and a logistic regression 
model will be used for adjusted analyses. For continuous outcomes, we will perform 

 
 
 
 
 
 
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19
analyses similar to those of the VO2peak outcome. Additionally, effect size (d) 
associated with the intervention will be calculated using Cohen's d and will be interpreted 
as small (d ≤ .2), moderate (d ~ .5), or large (d ≥ .8). We will explore whether results 
differ depending on level of SCI and length of time living with an SCI. We will use 
dummy variables for these two variables and test the interaction term (intervention-by-
the-dummy) in the model. 
 
Aim 2: We will use descriptive statistics to report on scales collected during and after 
sessions to further understand acceptability, feasibility, and fidelity. Our qualitative 
interviews will allow us to further explore whether patterns can be identified in 
participants who achieved improvement versus those who did not and those who 
dropped out of the study. Interview data will be transcribed, processed using NVivo, and 
analyzed using an adaptation of grounded theory analysis, which will include four steps 
to be employed iteratively: (1) open coding, in which particular concepts in the 
transcripts are identified and grouped into categories; (2) axial coding, in which 
categories are associated and related by conditions, actions/interactions, and 
consequences; (3) process coding, in which concepts and categories are examined in 
changing circumstances; and (4) selective coding, in which conceptual models and 
theories are developed, integrated, and refined. 
G5 Missing Outcome Data 
Only complete, valid data will be included in group analysis for each outcome measure 
for each participant. While missing outcome measure data will be excluded from group 
analysis, individual incomplete, invalid, or missing data may be analyzed on a case-by-
case basis to potentially further inform the study process and explain participant 
outcomes. 
G6  Unblinding Procedures  
Not applicable 
 
H Data Handling and Record Keeping  
 
H1 Confidentiality and Security 
All of the data will be treated confidentially, and the participants’ names and identities will 
not be disclosed in any published reports. The participants will be informed orally and in 
writing that they are free to withdraw from the study at any time with no bias or prejudice. 
The data obtained from this study will be kept confidential. Researchers will assign 
participants a code to de-identify all data according to HIPAA policies. Electronic data 
that contain private health, medical, or research information will be stored in a password-
protected computer behind firewalls, and will be maintained using the de-identified ID 
code to guarantee participant privacy. Only the PI, Dr. Kerri Morgan, and the research 
coordinator will have access to the code that matches the de-identified IDs to the patient 
identifiers. All hardcopy data records will be stored in locked file cabinets and kept in a 
locked office.  

 
 
 
 
 
 
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20
H2 Training  
All research personnel will be HIPPA certified, and personnel at Washington University 
will be human subject research certified.  
H3 Case Report Forms and Source Documents 
Not applicable 
H4 Records Retention 
Not applicable 
H5 Performance Monitoring  
Not applicable 
 
I Study Monitoring, Auditing, and Inspecting  
 
I1 
Study Monitoring Plan  
Not applicable 
I2 
Auditing and Inspecting  
Ongoing monitoring will also be conducted to ensure fidelity. All interventionists have 
worked with people with SCI, understand the implications of SCI, and have extensive 
knowledge about wheelchairs. Dr. Morgan will train all interventionists on the CBEI and 
EEG protocols. Interventionists will be asked to complete a practice session. To ensure 
standardization of the intervention delivery and to reduce drift, Dr. Morgan will monitor 
the fidelity of the training sessions by completing a fidelity monitoring checklist on 20% of 
the CBEI and EEG participants during one of the sessions. The monitoring checklist will 
include aspects of the session and instructions given by the interventionist. The research 
coordinator will review all participant (CBEI and EEG) files weekly to ensure that the 
interventionists are completing all paperwork and documenting intervention sessions. 
 
J Study Administration 
 
J1 Organization and Participating Centers 
Initial and post-assessments will be conducted at Washington University’s EMC 
research lab, located within the PQHWC building, and at the WUSM CARS CRU. CBEI 
training sessions will be conducted at the PQHWC. Trained research staff will be present 
for all assessments, and PQHWC staff will be present for safety monitoring of CBEI 
training sessions. 
J2 Funding Source and Conflicts of Interest 
National Institutes of Health. No conflicts of interest. 

 
 
 
 
 
 
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21
J3 Committees 
Not applicable 
J4 Subject Stipends or Payments  
Participants will be paid $50 for D1 of the initial assessment (T1) and $25 for D2 of the 
initial assessment. They will be paid $100 for D1 of the 12-week post-assessment (T2) 
and $25 for D2 of the 12-week post assessment. They will also be paid $50 for D1 of the 
follow-up assessment (T3).  Participants in the CBEI will receive a free 12-week gym 
membership to the PQHWC ($165 value). Participants in the EEG will be receive a free 
8-week gym membership to the PQHWC to be used after the intial 12 weeks. 
Participants will only be paid for sessions completed. 
J5  Study Timetable 
Project 
Activities 
Sept 
2018 
 
Oct-
Dec 
2018 
 
Jan-
Mar 
2019 
 
Apr-
Jun 
2019 
 
Jul-
Sept 
2019 
 
Oct-
Dec 
2019 
 
Jan-
Mar 
2020 
 
Apr-
Jun 
2020 
 
Jul-
Sept 
2020 
IRB approval 
x 
X 
 
 
 
 
 
Recruit and 
screen 
 
X 
X 
X 
X 
X 
X 
 
 
Initial testing 
 
X 
X 
X 
X 
X 
X 
 
 
Intervention 
 
X 
X 
X 
X 
X 
X 
X 
X 
Follow-up 
testing 
 
X 
X 
X 
X 
X 
X 
 
X 
 
 
X 
Data analysis 
 
 
 
 
 
 
 
X 
X 
Prepare 
manuscripts 
 
 
 
 
 
 
 
X 
X 
Present at 
conferences 
 
 
X 
 
X 
 
 
 
X 
 
X 
 
 
 
 
K Publication Plan  
 
Manuscript(s) will be written by Dr. Morgan and other research staff involved in the study 
and submitted for publication following the completion of the T1–T3 assessments, as 
well as following intervention completion. 
 
L  Attachments  
 
L1  Tables  
Not applicable 

 
 
 
 
 
 
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22
L2  Patient education brochures 
Not applicable 
L3  Special procedures protocols  
Not applicable 
L4  Questionnaires or surveys 
Characteristics of Respondents (CORE) survey, PROMIS measures, Leisure Time 
Physical Activity Questionnaire for People with SCI (LTPAQ-SCI);  The SCI Exercise 
Self-Efficacy Scale (ESES): Community Participation Index (CPI); RM 4-FM: Motivation 
for Physical Activity and Exercise/Working Out; 6-minute Push Test (6MPT); and 
qualitative questions. Attachments of these are included in the IRB application. 
 
M References 
 
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