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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post 8 week intervention
Awards & highlights

SCIPE Trial 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.Check my eligibility
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.See study design
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.

SCIPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a spinal cord injury causing paralysis from the chest down.

SCIPE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline physical activity level at week 8
Secondary outcome measures
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 outcome measures
Baseline outcome expectations
Baseline self-efficacy
Baseline self-regulation
+2 more

SCIPE 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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,282,768 Total Patients Enrolled

Media Library

Movement-to-Music Clinical Trial Eligibility Overview. Trial Name: NCT03925077 — N/A
Spinal Cord Injury Research Study Groups: Attention Control (AC), Movement to Music (M2M), Standardised Exercise Training (SET)
Spinal Cord Injury Clinical Trial 2023: Movement-to-Music Highlights & Side Effects. Trial Name: NCT03925077 — N/A
Movement-to-Music 2023 Treatment Timeline for Medical Study. Trial Name: NCT03925077 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have registered for this clinical research?

"Affirmative, the information accessible on clinicaltrials.gov suggests that this research is presently accepting participants. This trial was initially published on February 1st 2021 and recently updated on January 19th 2022. The study seeks to enroll 327 patients from a single medical centre."

Answered by AI

Is this medical trial open to participants that are over the age of 20?

"This clinical trial is limited to those aged 18–65. Meanwhile, there are 138 trials for minors and 732 studies targeting patients who have exceeded the age of 65."

Answered by AI

Who is qualified to take part in this clinical experiment?

"Candidates with spinal cord injuries and aged between 18 to 65 years old are eligible for enrollment in this clinical trial. As of now, approximately 327 participants have been recruited."

Answered by AI

Are participants being sought for this clinical trial?

"As per the information provided by clinicaltrials.gov, this trial is currently recruiting suitable candidates for participation. The study was introduced on February 1st 2021 and has been updated most recently on January 19th 2022."

Answered by AI
~30 spots leftby Sep 2024