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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

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+