- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925077
Spinal Cord Injury Program in Exercise (SCIPE)
August 28, 2023 updated by: Hui-Ju Young, PhD, University of Alabama at Birmingham
RERC on Technologies to Promote Exercise and Health Among People With Disabilities (A Scale Up Study Evaluating a Movement-to-Music Teleexercise Platform for Reaching a National Cohort of People With Spinal Cord Injury)
The purpose of this study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with spinal cord injury.
Enrolled participants will be randomized into one of three groups: a) M2M, b) SET, and c) attention control (AC).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of the Spinal Cord Injury Program in Exercise (SCIPE) study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with SCI.
The primary aim is to examine change in physical activity level after the 8-week M2M and SET interventions.
We hypothesize that participants in M2M and SET will have significant increase in physical activity compared to an Attention Control (AC) group after the 8-week intervention.
The secondary aim is to examine effects of the M2M and SET interventions on health and quality of life outcomes.
We hypothesize that participants in M2M and SET will have significant increases in sleep quality and quality of life and decreases in pain and fatigue compared to AC after the 8-week intervention.
Exercise enjoyment in M2M and SET participants will also be explored.
The tertiary aim is to evaluate the demographic (age, race, sex), clinical (level of injury, type of injury), and psychosocial (social support, outcome expectations, self-efficacy, self-regulation) variables of two participant groups: 1) compliant participants who completed ≥ 50% of the intervention, and 2) noncompliant participants who completed post-testing but < 50% of the intervention or who did not complete post-testing.
Study Type
Interventional
Enrollment (Estimated)
327
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sangeetha Padalabalanarayanan, MS
- Phone Number: 2059750550
- Email: sangee@uab.edu
Study Contact Backup
- Name: Hui-Ju (Zoe) Young, PhD
- Phone Number: 2054035521
- Email: hjyoung@uab.edu
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35209
- Recruiting
- RecTech Center
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Contact:
- Sangeetha Padalabalanarayanan, MS
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosed with a SCI resulting in incomplete or complete (C5 and below) paraplegia or tetraplegia;
- Demonstrate readiness to physical activity by completing the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
- Obtain medical clearance if required by PAR-Q+;
- Converse in and read English.
Exclusion Criteria:
- No broadband internet access;
- Significant visual impairment that prevents seeing a computer screen to follow a home exercise program;
- Currently pregnant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Movement to Music (M2M)
All M2M sessions are delivered using videos uploaded to a secure study website (the SCIPE website).
Participants in M2M will have access to the website and attend three 60-minute M2M sessions per week for a total of 8 weeks.
Each session provides rhythmic-based exercises that are choreographed to music to target range of motion, muscular strength, cardiorespiratory fitness, and balance.
In addition, participants in M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.
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The M2M program has been developed for onsite instruction and will be repurposed into an eHealth version.
The program is based on the positive effects of exercise and music on both physiological and psychosocial outcomes in people with disabilities.
Investigators aim to advance our current M2M program by enabling more robust personalization features, allowing people with SCI to individualize their M2M program.
Movement and tempo-based adaptations will also be available.
A typical M2M session will consist of tailored movement routines starting with a warmup using range of motion exercises, followed by muscle strengthening, cardiorespiratory, and/or balance routines, and ending with a cool down emphasizing breathing and mindfulness.
Other Names:
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Active Comparator: Standardised Exercise Training (SET)
All M2M sessions are delivered using videos uploaded to the SCIPE website.
Participants in SET will have access to the website and attend three 60-minute SET sessions per week for a total of 8 weeks.
Each session provides traditional exercises that target range of motion, muscular strength, cardiorespiratory fitness, and balance.
In addition, participants in M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.
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The SET program is based on the NCHPAD 14-Weeks to a Healthier You program launched in 2008.
Exercise videos including range of motion, muscle strengthening, cardio and balance routines performed both seated and standing have been developed and will be restructured for use in this study.
The SET program will be delivered through the same platform as M2M.
Other Names:
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No Intervention: Attention Control (AC)
Participants in AC will not have access to any exercise videos.
They will have access to the weekly educational articles on health and fitness, same as the ones received by the M2M and SET groups, through the SCIPE website.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline physical activity level at week 8
Time Frame: Baseline and post 8 week intervention
|
Physical activity is assessed using the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI).
The LTPAQ-SCI is a 3-item, self-report questionnaire that measures the number of days and minutes people with SCI spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days.
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Baseline and post 8 week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline pain intensity week 8
Time Frame: Baseline and post 8 week intervention
|
The intensity of pain is assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Adult Short Form 3a (v1.0).
The instrument is a 3-item measure with the response scores ranging from 1 (Had no pain) to 5 (Very severe).
Higher scores indicate higher pain intensity.
The total raw score will be translated into a T-score for each participant for analysis.
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Baseline and post 8 week intervention
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Changes from baseline pain interference at week 8
Time Frame: Baseline and post 8 week intervention
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The influence of pain on performing daily activities is assessed with the NIH PROMIS Pain Interference Adult Short Form 8a (v1.0), which contains 8 items with 5 response options ranging from 1 (Not at all) to 5 (Very much).
The form has raw scores range from 8 to 40, with higher scores indicating more pain interference.
The total raw score will be translated into a T-score for each participant for analysis.
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Baseline and post 8 week intervention
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Changes from baseline sleep quality at week 8
Time Frame: Baseline and post 8 week intervention
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Sleep quality is assessed using the NIH PROMIS Sleep Disturbance Adult Short Form 8a, which contains 8 items on a 5-point Likert scale, ranging from 1 (Very much) to 5 (Not at all).
The form has raw scores range from 8 to 40, with higher scores indicating worst sleep quality.
The total raw score will be translated into a T-score for each participant for analysis.
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Baseline and post 8 week intervention
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Changes from baseline fatigue level at week 8
Time Frame: Baseline and post 8 week intervention
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Fatigue is measured using the NIH PROMIS Fatigue Adult Short Form.
The instrument is a 8 items on a 5-point Likert scale, ranging from 1 (Not at all/Never) to 5 (Very much/Always).
Higher scores indicate higher fatigue.
The total raw score is translated into a T-score for each participant for analysis.
|
Baseline and post 8 week intervention
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Changes from baseline health-related quality of life at week 8
Time Frame: Baseline and post 8 week intervention
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Health-related quality of life is assessed using the NIH PROMIS 10 Global Health Items.
The Global-10 Health form is a 10-item measure with the response scores ranging from 1 (Poor/Not at all/Always/Very severe) to 5 (Excellent/Completely/Never/None).
One question item, "how would you rate your pain on average?", is on a 11-point Likert scale that ranges from 0 (No pain) to 10 (Worst pain imaginable).
Higher scores indicate better health-related quality of life.
Two summary scores, a Global Physical Health score and a Global Mental Health score, can be derived from this instrument.
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Baseline and post 8 week intervention
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Changes from baseline ability to participate in social roles and activities at week 8
Time Frame: Baseline and post 8 week intervention
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Social participation is measured using the NIH PROMIS Ability to Participate in Social Roles and Activities Short Form 8a.
The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never).
The lowest possible total raw score is 8 and the highest possible score is 40.
Higher scores indicate better ability to participate in social roles and activities.
The total raw score is translated into a T-score for each participant for analysis.
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Baseline and post 8 week intervention
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Exercise enjoyment at week 8
Time Frame: Post 8 week intervention
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Exercise enjoyment is assessed using Physical Activity Enjoyment Scale.
The Physical Activity Enjoyment Scale contains 8 items, with higher score indicates greater exercise enjoyment.
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Post 8 week intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline self-efficacy
Time Frame: Baseline
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Self-efficacy is measured using the Exercise Self-Efficacy Scale, which contains 8 items with response options of each item ranging from 0% (Not at all confident) to 100% (Highly confident).
Higher scores indicate higher levels of exercise self-efficacy.
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Baseline
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Baseline self-regulation
Time Frame: Baseline
|
Self-regulation is measured using the Exercise Goal-Setting Scale, which contains 10 items on a 5-point Likert scale that ranges from 1 (Does not describe) to 5 (Describes completely).
A higher mean score indicate better goal-setting and self-monitoring for exercise.
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Baseline
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Baseline social support
Time Frame: Baseline
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Social support is measured using the Social Provisions Scale, which contains 24 items with response options ranging from 1 (Strongly disagree) to 4 (Strongly agree).
A higher score indicates a greater degree of perceived support.
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Baseline
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Baseline outcome expectations
Time Frame: Baseline
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Outcome expectations is measured using the Multidimensional Outcome Expectations for Exercise Scale, which contains 15 items on a 5-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly agree).
Three domains of outcome expectations, including the physical outcome expectations, the social outcome expectations, and the self-evaluative outcome expectations, will be derived from this scale.
Each domain is scored individually and a higher score indicates higher level of outcome expectations for exercise.
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Baseline
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Participant adherence throughout the 8-week intervention period
Time Frame: During the 8-week intervention
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Participant dherence will be assessed using the percentage of the number of exercise session each participant attend over the 8-week intervention period.
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During the 8-week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 27, 2019
First Submitted That Met QC Criteria
April 20, 2019
First Posted (Actual)
April 23, 2019
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300003133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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