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Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495986
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
David Gater, 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Metabolic Syndrome Dietary Modification Paraplegia Tetraplegia Device: Functional Electrical Stimulation Leg Cycle Ergometry Behavioral: Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-Based Exercise & Diet Group
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Device: Functional Electrical Stimulation Leg Cycle Ergometry
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.

Behavioral: Diet
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.

Placebo Comparator: Home-Based Diet Alone Group
Diet intervention
Behavioral: Diet
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 Outcome Measures :
  1. Change in percent Body fat [ Time Frame: Baseline, 22 weeks ]
    Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA)

  2. Change in Fat Mass [ Time Frame: Baseline, 22 weeks ]
    Absolute Fat mass (FM) and Absolute Fat free mass (FFM) will be assessed in kilograms using DXA

  3. Change in Insulin Sensitivity (Si) [ Time Frame: Baseline, 22 weeks ]
    Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)

  4. Change in Glucose effectiveness (Sg) [ Time Frame: Baseline, 22 weeks ]
    Glucose Effectiveness will be measured using IVGTT

  5. Change in Basal Metabolic Rate (BMR) [ Time Frame: Baseline, 22 weeks ]
    BMR will be measured by indirect calorimetry


Secondary Outcome Measures :
  1. Change in High Density Lipoprotein cholesterol (HDL-C) level [ Time Frame: Baseline, 22 weeks ]
    HDL-C will be measured from blood serum samples

  2. Change in total cholesterol : HDL-C ratio [ Time Frame: Baseline, 22 weeks ]
    Total Cholesterol HDL-C ratio will be measured from blood serum samples

  3. Change in High sensitivity C-Reactive Protein (hsCRP) level [ Time Frame: Baseline, 22 weeks ]
    hsCRP will be measured from blood serum samples

  4. Change in Lower Extremity Bone Mineral Density (BMD) [ Time Frame: Baseline, 22 weeks ]
    BMD will be measured using DXA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495986


Contacts
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Contact: David Gater, D, PhD, MS 305-243-9516 dgater@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Dinorah Rodriguez, RN, BSN    305-243-2797    dinorah@med.miami.edu   
Principal Investigator: David Gater, MD         
United States, Pennsylvania
Milton S. Hershey Medical Center Completed
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
University of Miami
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: David Gater, MD, PhD, MS University of Miami
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Responsible Party: David Gater, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03495986    
Other Study ID Numbers: 20190659
R01HD091278-01 ( U.S. NIH Grant/Contract )
6996 ( Other Identifier: Pennsylvania State University )
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by David Gater, University of Miami:
Functional Electrical Stimulation
Exercise
Body Composition
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Paraplegia
Metabolic Syndrome
Wounds and Injuries
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations