Exercise to Reduce Obesity in Spinal Cord Injury

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00270855

First Posted: December 28, 2005

Last Update Posted: October 16, 2017

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. Read our disclaimer for details.

Collaborator:

National Center for Research Resources (NCRR)

Information provided by (Responsible Party):

VA Office of Research and Development

Purpose

The purpose of this proposal is to evaluate and compare the health benefits of using upper extremity exercise versus functional electrical stimulation for lower extremity exercise. It is our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES LCE) exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise will increase whole body energy expenditure, thereby increasing muscle mass, insulin sensitivity, glucose effectiveness and improving lipid profiles in adults with paraplegia.

Condition	Intervention
Diabetes Mellitus Obesity Paraplegia Quadriplegia Spinal Cord Injury	Procedure: Arm Crank Ergometry Procedure: FES Cycle Ergometer


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Exercise to Reduce Obesity in Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Spinal Cord Injuries

Genetic and Rare Diseases Information Center resources: Paraplegia

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

Determine which type of exercise modality will benefit SCI patients in the reduction of Metabolic Syndrome risk factors. [ Time Frame: baseline, 16 weeks ]


Estimated Enrollment:	24
Study Start Date:	May 2008
Study Completion Date:	December 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1 Upper body Cycle ergometer	Procedure: Arm Crank Ergometry Use of an upper body cycle to perform exercise.
Arm 2 Functional Electrical Stimulation Cycle Ergometer for Lower body	Procedure: FES Cycle Ergometer Use of an FES cycle ergometer to perform exercise

Detailed Description:

Objective: Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes, coronary artery disease, and upper extremity overuse syndrome as body weight increases. The specific objectives for the current proposal are to compare the impact of FES (functional electrical stimulation) lower extremity exercise versus upper extremity arm crank ergometry on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles, in adults with complete paraplegia. Research Plan: A randomized, baseline-controlled, prospective, 16-week interventional trial will be employed to assess the impact of FES LCE versus volitional arm crank ergometry exercise on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles in adults with complete paraplegia. Methods: Twenty-four 18-65 y.o. individuals with motor complete T4-L2 SCI will be assigned to either FES lower extremity exercise or upper extremity arm crank ergometry to compare impact on energy expenditure, obesity, and insulin sensitivity. Both groups will be provided similar nutritional assessments and intervention. Exercise training will consist of five, 40-minute sessions at 70% maximal heart rate (HRmax) each week for a total of 16 weeks. Resting metabolic rate, exercise energy expenditure, body composition by 4-compartment modeling, visceral adiposity, insulin sensitivity, glucose effectiveness, lipid profiles, and lower extremity bone mineral density (BMD) will be determined before and after 16-week exercise interventions.

Eligibility

Information from the National Library of Medicine

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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:

Criteria for participation will include men and women within the age range of 18-65 years old with BMI>25 kg/m2 who have had T4-L2 Motor-Complete (ASIA A&B) SCI for duration of greater than 12 months to ensure a homogenous sample.

Exclusion Criteria:

Persons who are unresponsive to surface neurostimulation, have participated in an FES or ACE exercise (> 60 minutes/week) program within the past 3 months, and those with known orthopedic limitations, CAD, diabetes mellitus (fasting glucose>126 or HgbA1c>7.0) or known family history, hypothyroidism, and/or renal disease will be excluded from the study. Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis, or pressure ulcers > Grade II will be excluded.

Contacts and Locations

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): NCT00270855

Locations


United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249

Sponsors and Collaborators

VA Office of Research and Development

National Center for Research Resources (NCRR)

Investigators


Principal Investigator:	David R Gater, MD PhD MS	Hunter Holmes McGuire VA Medical Center

More Information


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00270855 History of Changes
Other Study ID Numbers:	B3918-R UL1RR031990 ( U.S. NIH Grant/Contract )
First Submitted:	December 23, 2005
First Posted:	December 28, 2005
Last Update Posted:	October 16, 2017
Last Verified:	May 2012

Keywords provided by VA Office of Research and Development:


Body Composition Exercise Glucose Tolerance Insulin Sensitivity Functional Electric Stimulation

Additional relevant MeSH terms:


Diabetes Mellitus Wounds and Injuries Obesity Spinal Cord Injuries Paraplegia Quadriplegia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition	Nutrition Disorders Overweight Body Weight Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Paralysis Neurologic Manifestations

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