Exercise to Reduce Obesity in Spinal Cord Injury
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Exercise to Reduce Obesity in Spinal Cord Injury |
- Determine which type of exercise modality will benefit SCI patients in the reduction of Metabolic Syndrome risk factors. [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00270855
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| Principal Investigator: | David R Gater, MD PhD MS | Hunter Holmes McGuire VA Medical Center |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00270855 History of Changes |
| Other Study ID Numbers: | B3918-R, UL1RR031990 |
| Study First Received: | December 23, 2005 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Body Composition Exercise Glucose Tolerance Insulin Sensitivity Functional Electric Stimulation |
Additional relevant MeSH terms:
|
Diabetes Mellitus Obesity Paraplegia Quadriplegia Spinal Cord Injuries Body Weight Central Nervous System Diseases Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
Nervous System Diseases Neurologic Manifestations Nutrition Disorders Overnutrition Overweight Paralysis Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on February 25, 2015