Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

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Brief Title

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

Official Title

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

Interventional


Primary Outcome

Change in percent Body fat

Secondary Outcome

 Change in High Density Lipoprotein cholesterol (HDL-C) level

Condition

Spinal Cord Injuries

Intervention

Functional Electrical Stimulation Leg Cycle Ergometry

Study Arms / Comparison Groups

 Home-Based Exercise & Diet Group
Description:  16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

60

Start Date

June 10, 2021

Completion Date

May 31, 2023

Primary Completion Date

May 31, 2023

Eligibility 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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

David Gater, MD, PhD, MS, 305-243-9516, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03495986

Organization ID

20190659

Secondary IDs

R01HD091278-01

Responsible Party

Principal Investigator

Study Sponsor

University of Miami

Collaborators

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

Study Sponsor

David Gater, MD, PhD, MS, Principal Investigator, University of Miami


Verification Date

June 2021