NCT03495986

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high SCI. Primary outcome measures will include body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both groups will be routinely monitored via telemedicine while at home.

Conditions

• Spinal Cord Injuries
• Metabolic Syndrome
• Dietary Modification
• Paraplegia
• Tetraplegia

Interventions

Type	Name	Description
DEVICE	Functional Electrical Stimulation Leg Cycle Ergometry	Exercise training will consist of three to five, 40-67 minute sessions (200 minutes at target intensity) each week for a total of 16 weeks at 70% maximal heart rate; 10-minute warm-up and cool-down sessions will accompany each exercise session.
BEHAVIORAL	Diet	An individualized, detailed dietary plan consistent with My Healthy Plate Dietary Guidelines of America will be followed under supervision of Registered Dietitian with weekly telemedicine conferences and monitored dietary intake via MyFitnessPal.

Timeline

• Start date: 2021-06-10
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2018-04-12
• Last updated: 2025-12-22
• Results posted: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study