Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

University of Miami26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries Metabolic Syndrome Dietary Modification Paraplegia Tetraplegia

Interventions

Functional Electrical Stimulation Leg Cycle ErgometryDEVICE

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.

DietBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Percent Body Fat Assessed by DXA at Baseline and 21 Weeks

Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA). Assessments will be conducted at baseline and at 21 weeks to evaluate changes in body composition over time.