Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Dietary Modification
- Metabolic Syndrome
- Paraplegia
- Spinal Cord Injuries
- Tetraplegia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03495986
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Principal Investigator: David Gater, MD, PhD, MS University of Miami
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