Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Tetraplegia; Dietary Modification; Spinal Cord Injuries; Paraplegia
• Interventions: Device: Functional Electrical Stimulation Leg Cycle Ergometry; Behavioral: Diet

• Registration Number: NCT03495986
• Lead Sponsor: University of Miami

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-12
• Study Start: 2021-06-10
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-Based Exercise & Diet Group	Functional Electrical Stimulation Leg Cycle Ergometry	16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Home-Based Exercise & Diet Group	Diet	16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Home-Based Diet Alone Group	Diet	Diet intervention

Primary Outcome Measures

Name	Time	Method
Change in percent Body fat	Baseline, 21 weeks	Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA)
Change in Insulin Sensitivity (Si)	Baseline, 21 weeks	Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Change in Fat Mass	Baseline, 21 weeks	Absolute Fat mass (FM) and Absolute Fat free mass (FFM) will be assessed in kilograms using DXA
Change in Glucose effectiveness (Sg)	Baseline, 21 weeks	Glucose Effectiveness will be measured using IVGTT
Change in Basal Metabolic Rate (BMR)	Baseline, 21 weeks	BMR will be measured by indirect calorimetry

Secondary Outcome Measures

Name	Time	Method
Change in High Density Lipoprotein cholesterol (HDL-C) level	Baseline, 21 weeks	HDL-C will be measured from blood serum samples
Change in High sensitivity C-Reactive Protein (hsCRP) level	Baseline, 21 weeks	hsCRP will be measured from blood serum samples
Change in Lower Extremity Bone Mineral Density (BMD)	Baseline, 21 weeks	BMD will be measured using DXA
Change in total cholesterol : HDL-C ratio	Baseline, 21 weeks	Total Cholesterol HDL-C ratio will be measured from blood serum samples

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States