An interventional study of Movement-to-Music and Standard Exercise Training in Spinal Cord Injuries, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
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).
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.
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Exclusion Criteria:
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.
Other: Movement-to-Music
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.
Other: Standard Exercise Training
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.
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.
Other: Standard Exercise Training
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.
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.
Also known as: M2M
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.
Also known as: SET
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.
Time frame: Post 8-week intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post 8-week intervention
Participants were recruited through social media platforms (e.g., Instagram, Facebook) and word of mouth. Recruitment for the Feasibility Phase took place between February 2021 and March 2022. Recruitment for the Effectiveness Phase occurred between August 2023 and September 2024. Recruitment and enrollment for both study phases were performed separately.
| Milestone | Phase 1: Movement-to-Music (M2M) | Phase 1: Standard Exercise Training (SET) | Phase 1: Attention Control (AC) | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|---|---|---|
| Started | 12 | 12 | 12 | 0 | 0 |
| 8-week assessment | 8 | 10 | 10 | 0 | 0 |
| 12-week assessment | 5 | 8 | 9 | 0 | 0 |
| 16-week assessment | 5 | 8 | 8 | 0 | 0 |
| Completed | 5 | 8 | 8 | 0 | 0 |
| Not completed | 7 | 4 | 4 | 0 | 0 |
| Withdrew: Lost to follow-up | 7 | 4 | 4 | 0 | 0 |
| Milestone | Phase 1: Movement-to-Music (M2M) | Phase 1: Standard Exercise Training (SET) | Phase 1: Attention Control (AC) | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 30 | 30 |
| 8-week assessment | 0 | 0 | 0 | 19 | 23 |
| 12-week assessment | 0 | 0 | 0 | 22 | 22 |
| 16-week assessment | 0 | 0 | 0 | 21 | 22 |
| Completed | 0 | 0 | 0 | 21 | 22 |
| Not completed | 0 | 0 | 0 | 9 | 8 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 9 | 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.
| Minutes per week | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|
| Physical Activity Level at Week 8 | 383 ± 347 | 297 ± 227 |
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.
| T-score | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|
| Pain Intensity Week 8 | 53.5 ± 10.6 | 56.3 ± 9.9 |
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.
| T-score | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|
| Pain Interference at Week 8 | 53.6 ± 8.5 | 55.5 ± 8.9 |
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.
| T-score | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|
| Sleep Quality at Week 8 | 51.7 ± 5.6 | 52.7 ± 5.6 |
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.
| T-score | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|
| Fatigue Level at Week 8 | 50.1 ± 10.5 | 55.1 ± 9.7 |
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.
| T-score | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|
| Health-related Physical Quality of Life at Week 8 | 43.6 ± 8.5 | 41.3 ± 6.8 |
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.
| T-score | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) |
|---|---|---|
| Ability to Participate in Social Roles and Activities at Week 8 | 50.3 ± 9.0 | 45.4 ± 9.4 |
Collected over From enrollment until end of week-16 follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1: Movement-to-Music (M2M) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Phase 1: Standard Exercise Training (SET) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Phase 1: Attention Control (AC) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Phase 2: Standard Exercise Training (SET) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Phase 2: Attention Control (AC) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
We report baseline characteristics of participants in the Effectiveness phase here. Approval was received from the program officer to remove the M2M arm from the Effectiveness phase, after completing the Feasibility phase with the 3 study arms (M2M, SET, and AC).
| Age, Continuous(Years) | Phase 1: Movement-to-Music (M2M) | Phase 1: Standard Exercise Training (SET) | Phase 1: Attention Control (AC) | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) | Total |
|---|---|---|---|---|---|---|
| Mean | 42.0 ± 11.6 | 47.7 ± 11.8 | 46.4 ± 12.0 | 49.5 ± 10.8 | 47.3 ± 12.3 | 47.3 ± 11.6 |
| Sex: Female, Male(Participants) | Phase 1: Movement-to-Music (M2M) | Phase 1: Standard Exercise Training (SET) | Phase 1: Attention Control (AC) | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) | Total |
|---|---|---|---|---|---|---|
| Female | 6 | 5 | 8 | 20 | 17 | 56 |
| Male | 6 | 7 | 4 | 10 | 13 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1: Movement-to-Music (M2M) | Phase 1: Standard Exercise Training (SET) | Phase 1: Attention Control (AC) | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 | 4 | 2 | 10 |
| Not Hispanic or Latino | 11 | 11 | 9 | 26 | 28 | 85 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Phase 1: Movement-to-Music (M2M) | Phase 1: Standard Exercise Training (SET) | Phase 1: Attention Control (AC) | Phase 2: Standard Exercise Training (SET) | Phase 2: Attention Control (AC) | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 2 | 0 | 0 | 2 |
| Asian | 1 | 0 | 0 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 2 | 7 | 6 | 18 |
| White | 10 | 10 | 6 | 20 | 22 | 68 |
| More than one race | 0 | 0 | 0 | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 2 | 0 | 1 | 3 |
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University of Alabama at Birmingham