Telemonitored Exercise for Spinal Cord Injury

(TEAM-SCI Trial)

Overseen By Eduard Tiozzo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Anticoagulants

Disqualifiers: Orthopedic limitations, Coronary artery disease, Diabetes, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the health benefits of using functional electrical stimulation, a technique that uses small electrical pulses to help muscles move, for home exercise in people with spinal cord injuries. Participants will exercise at home 3-5 times a week for about 18-20 weeks, with supervision via teleconferencing. The trial suits women who participated in a specific past diet study and are not currently pregnant. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially enhance home exercise options for spinal cord injury patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, you cannot participate in the trial.

What prior data suggests that this method is safe for spinal cord injury exercise?

Research shows that exercising at home through video calls can be safe and feasible for people with spinal cord injuries. In one study, participants exercised at home under video supervision, and the study found this method safely increased their activity levels. Another study found that participants gained strength after performing these exercises.

These studies also examined whether the exercises caused any pain. Results suggest that any pain was manageable and did not prevent participants from continuing the program. Overall, the research supports that this type of exercise is well-tolerated by people with spinal cord injuries when done at home with remote guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to support spinal cord injury recovery through telemonitored exercise. Unlike traditional rehabilitation that often requires in-person visits, this approach allows participants to exercise at home while being supervised remotely via teleconference. This method offers greater flexibility and accessibility, potentially making it easier for individuals to stick to their exercise routines. Additionally, the trial aims to determine if this remote method can effectively support rehabilitation over an extended period of 18-20 weeks, which could revolutionize how therapy is delivered for spinal cord injuries.

What evidence suggests that this telemonitored exercise is effective for spinal cord injury?

Research shows that exercising through online programs, known as tele-exercise, benefits people with spinal cord injuries (SCI). Studies have found that it strengthens muscles and improves physical abilities. Participants in one study reported increased confidence in exercising and noticed better overall health. In this trial, participants in the Spinal Cord Injury Exercise Group will exercise at home 3-5 times per week under supervision via teleconference for 18-20 weeks. Tele-exercise helps people with SCI stay active at home, addressing challenges related to accessing a gym or exercise class. These findings suggest that tele-exercise could effectively help people with SCI stay healthy and move more easily. ^{1 2 3 4 6}

Who Is on the Research Team?

Eduard Tiozzo, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women who can become pregnant but agree not to during the study, were part of a previous diet-only spinal injury study, and are willing to wait 8 weeks after that study. It's not for those with kidney disease, on blood thinners, prisoners, pregnant or nursing women, recent severe spinal reflex issues or deep vein thrombosis, untreated thyroid problems or diabetes, certain heart diseases or pressure injuries.

Inclusion Criteria

Women of child-bearing potential who agree to refrain from getting pregnant during the trial

I was in the SCIENCE study's diet group and can wait 2 months after it ends.

Exclusion Criteria

I have a history of heart artery disease.

I have had issues making decisions due to a mental condition.

Participants who do not meet the inclusion criteria above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants complete a dietary intervention as part of the SCIENCE protocol

Not specified

Treatment

Participants engage in 16 weeks of home-based telemonitored functional electrical stimulation leg cycle ergometry exercise

16 weeks

3-5 sessions per week (teleconference)

Follow-up

Participants are monitored for changes in body composition and metabolic health

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Injury Exercise Group

Trial Overview The trial tests the health benefits of using electrical stimulation for leg exercises at home in individuals with spinal cord injuries. Participants will use this method to see if it helps manage metabolic issues caused by their condition.

How Is the Trial Designed?

Group I: Spinal Cord Injury Exercise Group Experimental Treatment 1 Intervention

Participants will exercise at home 3-5 times per week under supervision via teleconference. Participants will be part of this group for 18-20 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004304/

Tele-exercise in individuals with spinal cord injury Tele-exercise interventions are effective and feasible for individuals with spinal cord injury (SCI). These interventions often emphasize muscle strength and ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2524225

Tele-exercise and spinal cord injury: Effects on physical ... Our study showed that tele-exercise can overcome the accessibility obstacles imposed on people with SCI. The study findings corroborate results ...

3. archives-pmr.org archives-pmr.org/article/S0003-9993(23)00512-9/fulltext

Effect of Tele-exercise to Promote Empowered Movement ... A recent randomized controlled trial found that participants with SCI reported significantly improved physical function, exercise self-efficacy, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999323005129

Effect of Tele-exercise to Promote Empowered Movement ... This study identified the effect of TEEMS participation on critical determinants of PA behavior in individuals with SCI.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06585-2

Telehealth high-intensity interval exercise and ... - Trials The primary purpose of this study is to integrate a 16 week home-based telehealth HIIT arm crank exercise training program in individuals with SCI and assess ...

6. rehab.jmir.org rehab.jmir.org/2016/2/e8/

Teleexercise for Persons With Spinal Cord Injury Conclusion: A teleexercise system can be a safe and feasible option to deliver home-based exercise for persons with SCI. Participants responded ...