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

4 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.

Research Team

Eduard Tiozzo, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+