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Tele-Exercise for Spinal Cord Injury

N/A

Recruiting

Led By Margaret Finley, PhD

Research Sponsored by Drexel University

Eligibility Criteria Checklist

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

Must have

Self-reported age between 18-75 years

Report a complete or incomplete SCI of ASIA grade A, B, C, or D

Must not have

Self-report of recent osteoporotic fracture

Self-report of active pressure ulcer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to pre-program

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine the efficacy of an integrated, participant-centered tele-health physical activity program for individuals with SCI on psychological and social factors.

Who is the study for?

This trial is for adults aged 18-75 with spinal cord injury (SCI) who've lived with the injury for at least a year. They must be able to participate in virtual classes, have some shoulder mobility, and not be in structured rehabilitation. Excluded are those with recent fractures or hospitalization, active pressure ulcers, severe vision loss, or other neurological conditions.

What is being tested?

The study tests an 8-week group tele-exercise program designed to improve physical confidence and strength through virtual classes twice a week. It aims to assess psychological and social benefits using both surveys and interviews before and after the program.

What are the potential side effects?

Since this is an exercise-based intervention rather than medication, typical drug side effects aren't expected. However, participants may experience muscle soreness or fatigue related to increased physical activity.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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My spinal cord injury is classified as ASIA A, B, C, or D.

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I am not currently in a structured rehabilitation program.

Exclusion Criteria

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

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I have recently had a fracture due to osteoporosis.

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I have an active pressure ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-program (0 weeks) and post-program (8 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-program (0 weeks) and post-program (8 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-program (0 weeks) and post-program (8 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form at Week 8

Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 8

Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 8

+11 more

Secondary study objectives

Accelerometry

Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form from baseline to pre-program (Waitlist control group only)

Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 16

+15 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist ControlExperimental Treatment1 Intervention

The waitlist control group will complete all quantitative measures as a baseline (baseline-control) and will be instructed to continue their activities as usual, with measures obtained again at 8-weeks (post-control/pre-program). Following the initial 8-week baseline, each waitlist group will participate in pre-intervention semi-structured interview or small focus group with the post-control measures as pre-intervention assessment. They will join the tele-exercise intervention with all measures at 8-weeks (post-intervention) and with leisure time physical activity and quality of life assessed at 16-weeks following initiation of the program.

Group II: Group Tele-exercise ClassExperimental Treatment1 Intervention

Volunteers will be asked to participate in the group online exercise class 2 times per week for 8 weeks. Each activity session will last about 60 minutes and will focus on mind-body practices, tailored to physical and emotional needs of individuals with SCI. Class will be taught by a physical therapist who is an experienced community exercise instructor. Class will be co-led by a person who is living with SCI (one of our community partners). Classes will take place over a secure virtual platform (Zoom). Before beginning and after completion of the program, participants will be asked to participate in small group interviews to share expectations and experiences of the study

0 / 5Eligibility criteria met