Exercise Programs for Spinal Cord Injury

(SCIPE Trial)

Overseen By Sangeetha Padalabalanarayanan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: No internet, Visual impairment, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different exercise programs for people with spinal cord injuries to determine which might be more beneficial. Participants will join one of three groups: Movement-to-Music, Standard Exercise Training, or a control group receiving only health and fitness information. Individuals with a spinal cord injury affecting movement, who can read and speak English, and have internet access might be a good fit for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance exercise programs for individuals with spinal cord injuries.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these exercise programs are safe for individuals with spinal cord injury?

Research has shown that movement-to-music (M2M) programs are generally safe for people with spinal cord injuries. One study found that participants enjoyed the sessions, and no serious side effects occurred. The exercises improved muscle strength and fitness without causing harm.

For standard exercise training (SET), some minor issues like muscle soreness or tiredness have been reported, but these are common with any exercise program. Overall, the SET program is well-tolerated and considered safe for people with spinal cord injuries. There are no major safety concerns for either program, making them good options for increasing activity safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for spinal cord injury because they offer unique approaches to rehabilitation. The Movement-to-Music (M2M) treatment stands out by incorporating rhythmic exercises choreographed to music, which can make workouts more engaging and may enhance motivation and adherence. This method targets key areas like range of motion, strength, fitness, and balance, all while providing a more enjoyable experience compared to traditional exercises. Meanwhile, the Standard Exercise Training (SET) provides structured, traditional exercise sessions, which are also crucial for improving physical function but are delivered through a convenient online platform, making them more accessible. These innovative approaches could potentially improve rehabilitation outcomes by increasing patient engagement and consistency in exercise routines.

What evidence suggests that this trial's exercise programs could be effective for spinal cord injury?

Research shows that Movement-to-Music (M2M) programs, one of the treatment arms in this trial, can help people with spinal cord injuries become more active. Early results suggest that M2M can improve movement, strengthen muscles, and boost heart and lung health.

For Standard Exercise Training (SET), another treatment arm in this trial, studies have found that it can improve muscle health, prevent muscle loss, and enhance overall fitness. Participants in these studies also noticed better heart and blood vessel health. Both M2M and SET aim to help people with spinal cord injuries improve their physical health and well-being. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with spinal cord injury (SCI) resulting in paraplegia or tetraplegia (C5 and below), who can converse and read English, are ready for physical activity, and have internet access. It's not for those currently pregnant or with significant visual impairments that prevent following an exercise program on a computer screen.

Inclusion Criteria

Converse in and read English

Demonstrate readiness to physical activity by completing the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)

Obtain medical clearance if required by PAR-Q+

Exclusion Criteria

You do not have access to high-speed internet.

Currently pregnant

I cannot see well enough to follow exercises on a computer screen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week exercise intervention, either Movement-to-Music (M2M) or Standard Exercise Training (SET), with sessions delivered remotely via video

8 weeks

3 sessions per week (remote)

Follow-up

Participants are monitored for changes in physical activity, health-related quality of life, and other outcomes post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Movement-to-Music
• Standard Exercise Training

Trial Overview The study compares two 8-week remote exercise programs: Movement-to-Music (M2M) and Standard Exercise Training (SET). Participants will be randomly placed into M2M, SET, or an attention control group to evaluate the effectiveness of these interventions.

How Is the Trial Designed?

Group I: Attention Control (AC) Active Control 1 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.

Group II: Movement to Music (M2M) Active Control 1 Intervention

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.

Group III: Standardised Exercise Training (SET) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34412653/

The Spinal Cord Injury Program in Exercise (SCIPE) study The purpose of this study is to test the effectiveness of two remotely delivered exercise programs for people with SCI. ... Movement-to-Music ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525000709

Interim Analysis of the Spinal Cord Injury Program ... The interim analysis showed high feasibility and moderate usability and acceptability. Preliminary outcomes suggested potential benefits in physical activity ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03925077

NCT03925077 | Spinal Cord Injury Program in Exercise The purpose of this study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05751-2

The movement-to-music (M2M) study - Trials Journal The study is a two-arm randomized controlled efficacy trial examining a 12-week remotely delivered M2M intervention (eM2M) in 108 people with physical ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(25)00724-5/fulltext

Effects of a Teleexercise Movement-to-Music Intervention ... To examine the effects of a 12-week online movement-to-music (eM2M) intervention on health outcomes in people with mobility disabilities.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8574035/

The movement-to-music (M2M) study An E-learning program for increasing physical activity associated behaviors among people with spinal cord injury: usability study. JMIR Form ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004304/

Tele-exercise in individuals with spinal cord injury Tele-exercise interventions are effective and feasible for individuals with spinal cord injury (SCI). These interventions often emphasize muscle strength and ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05474-4

The Spinal Cord Injury Program in Exercise (SCIPE) study The purpose of this study is to test the effectiveness of two remotely delivered exercise programs for people with SCI.

9. archives-pmr.org archives-pmr.org/article/S0003-9993(23)00512-9/fulltext

Effect of Tele-exercise to Promote Empowered Movement ... An 8-week group tele-exercise program for individuals with SCI consisting of biweekly 60-minute classes delivered via live Web-conferencing software.