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Exercise Programs for Spinal Cord Injury (SCIPE Trial)

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with a SCI resulting in incomplete or complete (C5 and below) paraplegia or tetraplegia

Be older than 18 years old

Must not have

Significant visual impairment that prevents seeing a computer screen to follow a home exercise program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post 8 week intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if two different 8-week exercise programs can help adults with spinal cord injuries. One group will do a movement to music program, one will do a standard exercise program, and one will be the control group.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves exercise programs, potential side effects may include muscle soreness, fatigue, and risk of injury related to physical activity. Specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a spinal cord injury causing paralysis from the chest down.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes from baseline physical activity level at week 8

Secondary study objectives

Changes from baseline ability to participate in social roles and activities at week 8

Changes from baseline fatigue level at week 8

Changes from baseline health-related quality of life at week 8

+4 more

Other study objectives

Baseline outcome expectations

Baseline self-efficacy

Baseline self-regulation

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Attention Control (AC)Active Control1 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 Control1 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 Control1 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.

0 / 2Eligibility criteria met