Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

Conditions
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Spinal Cord Injuries, Metabolic Syndrome, Dietary Modification, Paraplegia, Tetraplegia

Intervention / Treatment
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* Device: Functional Electrical Stimulation Leg Cycle Ergometry
* Behavioral: Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-Based Exercise & Diet Group<br>16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention | Device: Functional Electrical Stimulation Leg Cycle Ergometry<br>* 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.<br>Behavioral: Diet<br>* 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.<br>|
| Placebo Comparator: Home-Based Diet Alone Group<br>Diet intervention | Behavioral: Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Electrical Stimulation, Exercise, Body Composition