Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    60
  • sponsor
    University of Miami
Updated on 4 July 2021
electrical stimulation
spinal cord
spinal cord disorder
home exercise program

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.

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.

Details
Condition Paraplegia, Metabolic disorder, Dietary Modification, Spinal Cord Injury, Myelopathy, Trauma, Quadriplegia, Metabolic syndrome, Limb Spasticity, Spinal Cord Injuries, Wounds, Spinal Cord Disorders, Metabolic Disorders, tetraplegia, metabolic syndrome x, nutritional interventions, dietary intervention, diet modification, nutrition intervention, dietary interventions
Treatment diet, Functional Electrical Stimulation Leg Cycle Ergometry
Clinical Study IdentifierNCT03495986
SponsorUniversity of Miami
Last Modified on4 July 2021

Eligibility

Yes No Not Sure

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
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