Exercise to Reduce Obesity in Spinal Cord Injury

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00270855
First received: December 23, 2005
Last updated: May 21, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

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 ] [ 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270855

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Investigators
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 October 23, 2014