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Telemonitored Exercise for Spinal Cord Injury (TEAM-SCI Trial)

N/A
Recruiting
Led By Eduard Tiozzo, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 20 weeks (post intervention)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if electrical stimulation exercise can improve health at home.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, similar interventions may cause skin irritation where electrodes are placed and muscle fatigue due to exercise. There could also be an increased risk of autonomic dysreflexia—a potentially serious complication common in people with spinal injuries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 20 weeks (post intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 20 weeks (post intervention) 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 percent body fat
Change in percent of fat free mass
Change in percent of lean body mass
+1 more
Secondary study objectives
Body Weight Changes
Change in Insulin levels
Body Weight Changes
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Spinal Cord Injury Exercise GroupExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
949 Previous Clinical Trials
428,437 Total Patients Enrolled
Eduard Tiozzo, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Spinal Cord Injury Exercise Group (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05597176 — N/A
Spinal Injury Research Study Groups: Spinal Cord Injury Exercise Group
Spinal Injury Clinical Trial 2023: Spinal Cord Injury Exercise Group Highlights & Side Effects. Trial Name: NCT05597176 — N/A
Spinal Cord Injury Exercise Group (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597176 — N/A
~1 spots leftby Dec 2024
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