35 Participants Needed

Tele-Exercise for Spinal Cord Injury

MF
LB
EP
Overseen ByEmelia Perry, OT,L
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The objective of this study is to examine the efficacy of an integrated, participant-centered tele-health physical activity program for individuals with SCI on psychological and social factors through a parallel mixed-methods design approach. We will examine changes in psychological (self-efficacy, self-esteem, exercise outcome expectations, depression, positive affect and well-being, quality of life) and social factors (participation and satisfaction with social roles and activities, activity engagement) following participation in an 8-week integrated group tele-exercise health and wellness physical activity program, with retention assessed at 8-weeks following completion (16 weeks from baseline). We will also complete small group interviews with all participants to understand participant experiences of, response to, and recommendations before and following participation in group tele-exercise program. To date, there is extremely limited evidence for the efficacy of psychological and social well-being of remotely delivered community-based exercise to individuals with SCI. A pilot effectiveness trial of a tele-exercise health and wellness program will be conducted using a mixed methods design with a randomized waitlist control group. Quantitative and qualitative data collection is sequential in nature and other data are collected simultaneously. Individuals with SCI (living with injury 12 months or longer) will be recruited based on existing partnerships locally and nationally. To assess limited effectiveness, we aim to enroll 35 individuals with SCI. Recruitment of these participants will stem from the investigator's ongoing community partnership with local and national partners. The tele-exercise health \& wellness program will consist of virtual group class, twice per week, intended to generate physical confidence and strength for individuals living with SCI. Each session will be co-led with by an individual living with SCI.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Tele-Exercise for Spinal Cord Injury?

Research shows that tele-exercise can help people with spinal cord injuries stay active, especially when in-person exercise is difficult. It offers a way to continue exercising safely from home, which is important for maintaining health and well-being.12345

Is tele-exercise safe for people with spinal cord injury?

The studies suggest that tele-exercise programs are feasible and offer a safe way for individuals with spinal cord injury to engage in physical activity, especially during times when in-person sessions are not possible.12356

How is the tele-exercise treatment for spinal cord injury different from other treatments?

Tele-exercise is unique because it allows individuals with spinal cord injury to participate in group exercise sessions remotely, overcoming barriers like transportation and accessibility that often prevent regular exercise. This approach is particularly beneficial during times of social isolation, such as the COVID-19 pandemic, and provides a way to maintain physical activity without needing in-person sessions.12356

Research Team

MF

Margaret Finley, PhD

Principal Investigator

Drexel University

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 75 years old.
Living with injury for at least 12 months
My spinal cord injury is classified as ASIA A, B, C, or D.
See 4 more

Exclusion Criteria

Absolute contraindications as identified by ACSM21
Self-report of preexisting neurological conditions other than SCI
Self-report of uncorrectable vision loss
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Participants complete semi-structured interviews or small focus groups and quantitative measures are obtained

1 week
1 visit (virtual)

Tele-exercise Intervention

Participants engage in a group tele-exercise class twice per week for 8 weeks, focusing on mind-body practices tailored to individuals with SCI

8 weeks
16 sessions (virtual)

Post-Intervention Assessment

Participants complete post-intervention measures including leisure time physical activity and quality of life assessments

1 week
1 visit (virtual)

Follow-up

Participants are monitored for retention of physical activity and quality of life improvements

8 weeks
1 visit (virtual)

Treatment Details

Interventions

  • Group tele-exercise
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials
160
Recruited
48,600+

The Craig H. Neilsen Foundation

Collaborator

Trials
62
Recruited
3,100+

Pennsylvania Department of Health

Collaborator

Trials
42
Recruited
999,000+

Findings from Research

Tele-exercise training for individuals with tetraplegia was found to meet the moderate intensity recommendations of spinal cord injury (SCI) exercise guidelines over a 27-week period, indicating its potential as a viable alternative for remote physical training.
The study reported a 45.1% adherence rate to the tele-exercise program, with men showing higher adherence than women, suggesting that while tele-exercise can be beneficial, strategies may be needed to improve participation among all individuals.
Does tele-exercise training for tetraplegia meet the spinal cord injury-specific physical activity guidelines? A 7-month longitudinal study.Gomes Costa, RR., Dorneles, JR., Veloso, JHCL., et al.[2023]
In a study involving 40 individuals with spinal cord injury, synchronous tele-exercise programs resulted in significantly higher weekly training loads and better adherence compared to asynchronous programs over a 3-week period.
While both types of tele-exercise had similar average daily workloads, the synchronous approach allowed for more effective implementation, leading to greater overall exercise success and engagement.
Synchronous and asynchronous tele-exercise during the coronavirus disease 2019 pandemic: Comparisons of implementation and training load in individuals with spinal cord injury.Costa, RRG., Dorneles, JR., Veloso, JH., et al.[2023]
A preliminary study involving 4 participants with spinal cord injury showed that an online group-based physical activity program, conducted twice weekly for six weeks, was highly accepted and beneficial for their physical and psychosocial wellbeing.
Participants reported improvements in anxiety and satisfaction with social roles and activities, suggesting that online physical activity programs can be a viable alternative during situations like a pandemic, enhancing overall quality of life for individuals with spinal cord injuries.
Feasibility of a virtual service delivery model to support physical activity engagement during the COVID-19 pandemic for those with spinal cord injury.Mehta, S., Ahrens, J., Abu-Jurji, Z., et al.[2022]

References

Does tele-exercise training for tetraplegia meet the spinal cord injury-specific physical activity guidelines? A 7-month longitudinal study. [2023]
Synchronous and asynchronous tele-exercise during the coronavirus disease 2019 pandemic: Comparisons of implementation and training load in individuals with spinal cord injury. [2023]
Feasibility of a virtual service delivery model to support physical activity engagement during the COVID-19 pandemic for those with spinal cord injury. [2022]
Functional and clinical outcomes of telemedicine in patients with spinal cord injury. [2019]
Development and Feasibility of a Group Tele-Exercise Program for Individuals With Spinal Cord Injury. [2023]
Effectiveness of home exercise on pain, function, and strength of manual wheelchair users with spinal cord injury: a high-dose shoulder program with telerehabilitation. [2022]