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Completed

NCT Number: NCT03495986

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

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.

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Key information

Conditions

Spinal Cord Injuries Behavior Central Nervous System Diseases Dietary Modification Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Motor Activity Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Electrical Stimulation Leg Cycle Ergometry

Device

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.

Diet

Behavioral

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.

Primary outcomes

  1. Percent Body Fat Assessed by DXA at Baseline and 21 Weeks

    Time frame: Baseline, 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.

  2. Fat Free Mass

    Time frame: Baseline, 21 weeks

    Body composition will be assessed using Dual-Energy X-ray Absorptiometry (DXA), which provides precise measurements of both absolute fat mass (FM) and absolute fat-free mass (FFM) in kilograms. FFM represents a distinct component of total body mass and will be used to evaluate lean tissue (i.e.,FFM) over time.

  3. Change in Insulin Sensitivity (Si)

    Time frame: Baseline, 21 weeks

    Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)

  4. Change in Glucose Effectiveness (Sg)

    Time frame: Baseline, 21 weeks

    Glucose Effectiveness will be measured using IVGTT

  5. Change in Basal Metabolic Rate (BMR)

    Time frame: Baseline, 21 weeks

    BMR will be measured by indirect calorimetry

Secondary outcomes

  1. High Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline, 21 weeks

    HDL-C will be measured from blood serum samples

  2. Change in Total Cholesterol : HDL-C Ratio

    Time frame: Baseline, 21 weeks

    Total Cholesterol HDL-C ratio will be calculated from blood serum samples reported as a numeric value, representing the ratio of Total Cholesterol to HDL-C.

  3. C-Reactive Protein (hsCRP)

    Time frame: Baseline, 21 weeks

    hsCRP will be measured from blood serum samples

  4. Lower Extremity Bone Mineral Density (BMD) - Femur

    Time frame: Baseline, 21 weeks

    The changes in Bone Mineral Density will be measured using DXA scan

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

Acronym: SCIENCE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2018
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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