CompletedNot Applicable

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

United States26 participantsStarted 2021-06-10

Plain-language summary

Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Adults 18-65 years of age (inclusive) * Sex: male or female * Women of child-bearing potential who agree to refrain from getting pregnant during the trial * C4-T4 motor complete (AIS A\&B) spinal cord injury for duration greater than 12 months * \<5% change in body weight over the past 12 months Exclusion criteria: * \<22% body fat * Unresponsive to neurostimulation * Those who have participated in an FES or ACE exercise program (\>60 minutes/week) within the past 3 months * Known orthopaedic limitations * Coronary artery disease * Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose\>126 or HgbA1c\>7.0) * Uncompensated Hypothyroidism (Stable on medication \>1 year or not on medication) * Renal disease * Uncontrolled autonomic dysreflexia, recent (within 3 months) * Deep vein thrombosis * Pressure ulcers \> Grade II * Decisional impairment * Any potential causes of autonomic dysreflexia at the discretion of the PI * Prisoners * Pregnant or nursing women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Body Fat Assessed by DXA at Baseline and 21 Weeks

Timeframe: Baseline, 21 weeks

Fat Free Mass

Timeframe: Baseline, 21 weeks

Change in Insulin Sensitivity (Si)

Timeframe: Baseline, 21 weeks

Change in Glucose Effectiveness (Sg)

Timeframe: Baseline, 21 weeks

Change in Basal Metabolic Rate (BMR)

Timeframe: Baseline, 21 weeks

Trial details

NCT IDNCT03495986

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-24

Results submitted2025-07-23

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent Body Fat Assessed by DXA at Baseline and 21 Weeks

Timeframe: Baseline, 21 weeks

Fat Free Mass

Timeframe: Baseline, 21 weeks

Change in Insulin Sensitivity (Si)

Timeframe: Baseline, 21 weeks

Change in Glucose Effectiveness (Sg)

Timeframe: Baseline, 21 weeks

Change in Basal Metabolic Rate (BMR)

Timeframe: Baseline, 21 weeks