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Trial record 3 of 15 for:    spinal cord injury AND cycling | Recruiting, Not yet recruiting, Available Studies

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

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ClinicalTrials.gov Identifier: NCT03495986
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
David R. Gater, MD, PhD, MS, Milton S. Hershey Medical Center

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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)
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 2022


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. Percent Body fat [ Time Frame: Change from Baseline at 22 weeks ]
  2. Fat Mass and Fat-Free Mass [ Time Frame: Change from Baseline at 22 weeks ]
    measured in kgs

  3. Insulin Sensitivity (Si) [ Time Frame: Change from Baseline at 22 weeks ]
  4. Glucose effectiveness (Sg) [ Time Frame: Change from Baseline at 22 weeks ]
  5. Basal Metabolic Rate [ Time Frame: Change from Baseline at 22 weeks ]

Secondary Outcome Measures :
  1. Lipid Profiles [ Time Frame: Change from Baseline at 22 weeks ]
  2. High sensitivity C-Reactive Protein (hsCRP) level [ Time Frame: Change from Baseline at 22 weeks ]
  3. Lower Extremity Bone Mineral Density [ Time Frame: Change from Baseline at 22 weeks ]


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

Inclusion Criteria:

  • 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
  • Women of child-bearing potential who agree to refrain from getting pregnant during the trial
  • Fluent in written and spoken English

Exclusion Criteria:

  • <22% body fat
  • Unresponsive to surface neurostimulation
  • Those who have participated in an FES or ACE exercise program (>60 minutes/week) within the past 3 months
  • Known orthopedic limitations
  • Coronary artery disease
  • Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose>126 or HgbA1c>7.0)
  • Hypothyroidism, and/or renal disease
  • Uncontrolled autonomic dysreflexia, recent (within 3 months)
  • Deep Vein Thrombosis
  • Pressure ulcers > Grade II
  • Pregnant or nursing woman
  • Decisional impairment
  • Prisoner

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


Locations
United States, Pennsylvania
Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Research Coordinator    717-531-0003 ext 283816    PMR_Research@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: David Gater, MD, PhD, MS Milton S. Hershey Medical Center

Responsible Party: David R. Gater, MD, PhD, MS, Chair, Physical Medicine and Rehabilitation, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03495986     History of Changes
Other Study ID Numbers: 6996
R01HD091278-01 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by David R. Gater, MD, PhD, MS, Milton S. Hershey Medical Center:
Functional Electrical Stimulation
Exercise
Body Composition

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Trauma, Nervous System
Metabolic Syndrome X
Quadriplegia
Paraplegia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms