Clinical trial NCT00270855: Exercise to Reduce Obesity in Spinal Cord Injury
Official title: Exercise to Reduce Obesity in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Paraplegia
Quadriplegia
Spinal Cord Injury
Keywords: Body Composition
Exercise
Glucose Tolerance
Insulin Sensitivity
Functional Electric Stimulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2005-12-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 were 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 was 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 were 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 were provided similar nutritional assessments and intervention. Exercise training consisted 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 DXA, insulin sensitivity, glucose effectiveness, lipid profiles, and lower extremity bone mineral density (BMD) were determined before and after 16-week exercise interventions.

Eligibility criteria: Inclusion Criteria:

Criteria for participation included 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 were unresponsive to surface neurostimulation
* had 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 were excluded from the study.
* Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis, or pressure ulcers \> Grade II were excluded.

Primary outcomes:
measure: Change in % Body Fat
timeFrame: baseline, 16 weeks
measure: Change in Fat Mass
timeFrame: Baseline, 16 Weeks
measure: Change in Fat-Free Mass
timeFrame: baseline, 16 weeks
measure: Change in Glucose Effectiveness (Sg)
timeFrame: Baseline, 16-weeks
measure: Change in Insulin Sensitivity (Si)
timeFrame: Baseline, 16-weeks
measure: %Body Fat Between Groups
timeFrame: 16 weeks
measure: Fat Mass Between Groups
timeFrame: 16 weeks
measure: Fat Free Mass Between Groups
timeFrame: 16 weeks
measure: Insulin Sensitivity (Si) Between Groups
timeFrame: 16 weeks
measure: Glucose Effectiveness (Sg) Between Groups
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Lower Limb Bone Mineral Density
timeFrame: baseline, 16 weeks
measure: Change in Lower Limb Bone Mineral Content
timeFrame: baseline, 16 weeks
measure: Change in Triglycerides
timeFrame: baseline, 16 weeks
measure: Change in High Density Lipoprotein Cholesterol (HDL)
timeFrame: baseline, 16 weeks
measure: Change in Low Density Lipoprotein Cholesterol (LDL)
timeFrame: baseline, 16 weeks
measure: Change in Total Cholesterol (TC)
timeFrame: baseline, 16 weeks
measure: Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)
timeFrame: Baseline, 16 weeks
measure: Lower Limb Bone Mineral Density Between Groups
timeFrame: 16 weeks
measure: Lower Limb Bone Mineral Content Between Groups
timeFrame: 16 weeks
measure: Triglycerides Between Groups
timeFrame: 16 weeks
measure: High Density Lipoprotein Cholesterol (HDL) Between Groups
timeFrame: 16 weeks
measure: Low Density Lipoprotein Cholesterol (LDL) Between Groups
timeFrame: 16 weeks
measure: Total Cholesterol (TC) Between Groups
timeFrame: 16 weeks
measure: Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups
timeFrame: 16 weeks
Other outcomes:
measure: Change in Resting Metabolic Rate
timeFrame: baseline, 16 weeks
measure: Resting Metabolic Rate Between Groups
timeFrame: 16 weeks
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Hunter Holmes McGuire VA Medical Center
name: David R Gater, MD PhD MS
role: PRINCIPAL_INVESTIGATOR
References: