Spinal Cord InjuriesSCIPENCT03925077
Spinal Cord Injury Program in Exercise
A study testing Movement-to-Music and Standard Exercise Training in people with Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Movement-to-Music and Standard Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No broadband internet access;
- Significant visual impairment that prevents seeing a computer screen to follow a home exercise program;
- Currently pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Movement-to-Music, Standard Exercise Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement-to-MusicOther
Also called M2M
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.
Standard Exercise TrainingOther
Also called SET
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Movement-to-Music (M2M) | Active comparator | 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. Receives: Other: Movement-to-Music |
| Phase 1: Standard Exercise Training (SET) | Active comparator | All SET 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 SET will receive and read weekly educational articles on health and fitness through the SCIPE website. Receives: Other: Standard Exercise Training |
| Phase 1: Attention Control (AC) | No intervention | 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. |
| Phase 2: Standard Exercise Training (SET) | Active comparator | All SET 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 SET will receive and read weekly educational articles on health and fitness through the SCIPE website. Receives: Other: Standard Exercise Training |
| Phase 2: Attention Control (AC) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level at Week 8
Physical activity was 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 minutes people with spinal cord injury spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days.
Measured: Post 8-week intervention
Secondary outcomes (6)
Pain Intensity Week 8
The pain intensity was 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). The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis. Higher scores indicate higher pain intensity.
Measured: Post 8-week intervention
Pain Interference at Week 8
The influence of pain on performing daily activities was assessed with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference Adult Short Form 8a (v1.0). The form 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 is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.
Measured: Post 8-week intervention
Sleep Quality at Week 8
Sleep quality is assessed using the NIH Patient-Reported Outcomes Measurement Information System (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 is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.
Measured: Post 8 week intervention
Fatigue Level at Week 8
Fatigue was measured using the NIH Patient-Reported Outcomes Measurement Information System (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 converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.
Measured: Post 8-week intervention
Health-related Physical Quality of Life at Week 8
Health-related quality of life was assessed using the NIH Patient-Reported Outcomes Measurement Information System (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. The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.
Measured: Post 8-week intervention
Ability to Participate in Social Roles and Activities at Week 8
Social participation was measured using the NIH Patient-Reported Outcomes Measurement Information System (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 converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.each participant for analysis.
Measured: Post 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Feb 2021
- Primary completion22 Nov 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Ju Young, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925077
- Sponsor's protocol ID
- IRB-300003133
- Other IDs
- 90DPGE0005
- Acronym
- SCIPE
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2019
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young HJ, Mehta T, Kim Y, Padalabalanarayanan S, Chiu CY, Rimmer JH, Thirumalai M. The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury. Trials. 2021 Aug 19;22(1):551. doi: 10.1186/s13063-021-05474-4.
PubMed 34412653
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03925077
- Acronym / sponsor ID
- SCIPE / IRB-300003133
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Movement-to-Music (M2M) | Active comparator | Other: Movement-to-MusicAll 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. |
| Phase 1: Standard Exercise Training (SET) | Active comparator | Other: Standard Exercise TrainingAll SET 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 SET will receive and read weekly educational articles on health and fitness through the SCIPE website. |
| Phase 1: Attention Control (AC) | No intervention | –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. |
| Phase 2: Standard Exercise Training (SET) | Active comparator | Other: Standard Exercise TrainingAll SET 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 SET will receive and read weekly educational articles on health and fitness through the SCIPE website. |
| Phase 2: Attention Control (AC) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- No broadband internet access;
- Significant visual impairment that prevents seeing a computer screen to follow a home exercise program;
- Currently pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement-to-MusicAlso: M2MThe 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 | Phase 1: Movement-to-Music (M2M) |
| Standard Exercise TrainingAlso: SETThe 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 | Phase 1: Standard Exercise Training (SET), Phase 2: Standard Exercise Training (SET) |
Primary outcome
Physical Activity Level at Week 8
Time frame: Post 8-week intervention
Physical activity was 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 minutes people with spinal cord injury spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days.
6 secondary outcomes
Pain Intensity Week 8
Time frame: Post 8-week intervention
Pain Interference at Week 8
Time frame: Post 8-week intervention
Sleep Quality at Week 8
Time frame: Post 8 week intervention
Fatigue Level at Week 8
Time frame: Post 8-week intervention
Health-related Physical Quality of Life at Week 8
Time frame: Post 8-week intervention
Ability to Participate in Social Roles and Activities at Week 8
Time frame: Post 8-week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34412653Young HJ, Mehta T, Kim Y, Padalabalanarayanan S, Chiu CY, Rimmer JH, Thirumalai M. The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury. Trials. 2021 Aug 19;22(1):551. doi: 10.1186/s13063-021-05474-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement-to-Music and Standard Exercise Training in people with Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level at Week 8 (time frame: Post 8-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03925077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.