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Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

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ClinicalTrials.gov Identifier: NCT03495986
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : May 25, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
David Gater, University of Miami

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date May 25, 2022
Actual Study Start Date  ICMJE June 10, 2021
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2021)
  • Change in percent Body fat [ Time Frame: Baseline, 21 weeks ]
    Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA)
  • Change in Fat Mass [ Time Frame: Baseline, 21 weeks ]
    Absolute Fat mass (FM) and Absolute Fat free mass (FFM) will be assessed in kilograms using DXA
  • Change in Insulin Sensitivity (Si) [ Time Frame: Baseline, 21 weeks ]
    Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
  • Change in Glucose effectiveness (Sg) [ Time Frame: Baseline, 21 weeks ]
    Glucose Effectiveness will be measured using IVGTT
  • Change in Basal Metabolic Rate (BMR) [ Time Frame: Baseline, 21 weeks ]
    BMR will be measured by indirect calorimetry
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Percent Body fat [ Time Frame: Change from Baseline at 22 weeks ]
  • Fat Mass and Fat-Free Mass [ Time Frame: Change from Baseline at 22 weeks ]
    measured in kgs
  • Insulin Sensitivity (Si) [ Time Frame: Change from Baseline at 22 weeks ]
  • Glucose effectiveness (Sg) [ Time Frame: Change from Baseline at 22 weeks ]
  • Basal Metabolic Rate [ Time Frame: Change from Baseline at 22 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2021)
  • Change in High Density Lipoprotein cholesterol (HDL-C) level [ Time Frame: Baseline, 21 weeks ]
    HDL-C will be measured from blood serum samples
  • Change in total cholesterol : HDL-C ratio [ Time Frame: Baseline, 21 weeks ]
    Total Cholesterol HDL-C ratio will be measured from blood serum samples
  • Change in High sensitivity C-Reactive Protein (hsCRP) level [ Time Frame: Baseline, 21 weeks ]
    hsCRP will be measured from blood serum samples
  • Change in Lower Extremity Bone Mineral Density (BMD) [ Time Frame: Baseline, 21 weeks ]
    BMD will be measured using DXA
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Lipid Profiles [ Time Frame: Change from Baseline at 22 weeks ]
  • High sensitivity C-Reactive Protein (hsCRP) level [ Time Frame: Change from Baseline at 22 weeks ]
  • Lower Extremity Bone Mineral Density [ Time Frame: Change from Baseline at 22 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
Official Title  ICMJE Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Metabolic Syndrome
  • Dietary Modification
  • Paraplegia
  • Tetraplegia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Home-Based Exercise & Diet Group
    16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
    Interventions:
    • Device: Functional Electrical Stimulation Leg Cycle Ergometry
    • Behavioral: Diet
  • Placebo Comparator: Home-Based Diet Alone Group
    Diet intervention
    Intervention: Behavioral: Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
40
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Gater, D, PhD, MS 305-243-9516 dgater@miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495986
Other Study ID Numbers  ICMJE 20190659
R01HD091278-01 ( U.S. NIH Grant/Contract )
6996 ( Other Identifier: Pennsylvania State University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party David Gater, University of Miami
Original Responsible Party David R. Gater, MD, PhD, MS, Milton S. Hershey Medical Center, Chair, Physical Medicine and Rehabilitation
Current Study Sponsor  ICMJE University of Miami
Original Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: David Gater, MD, PhD, MS University of Miami
PRS Account University of Miami
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP