Exercise to Reduce Obesity in Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise to Reduce Obesity in Spinal Cord Injury

Conditions
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Diabetes Mellitus, Obesity, Paraplegia, Quadriplegia, Spinal Cord Injury

Intervention / Treatment
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* Procedure: Arm Crank Ergometry
* Procedure: FES Cycle Ergometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm Crank Ergometer<br>Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks | Procedure: Arm Crank Ergometry<br>* Use of an upper body cycle to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks<br>|
| Other: FESLCE<br>Functional Electrical Stimulation Leg Cycle Ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks | Procedure: FES Cycle Ergometer<br>* Use of an FES cycle ergometer to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in % Body Fat | Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in Fat Mass | Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16 Weeks | 
| Change in Fat-Free Mass | Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in Glucose Effectiveness (Sg) | Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16-weeks | 
| Change in Insulin Sensitivity (Si) | Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16-weeks | 
| %Body Fat Between Groups | Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks | 
| Fat Mass Between Groups | Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks | 
| Fat Free Mass Between Groups | Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks | 
| Insulin Sensitivity (Si) Between Groups | Comparison of Si between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks | 
| Glucose Effectiveness (Sg) Between Groups | Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lower Limb Bone Mineral Density | Change in lower limb bone mineral density after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in Lower Limb Bone Mineral Content | Change in lower limb bone mineral content after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in Triglycerides | Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in High Density Lipoprotein Cholesterol (HDL) | Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in Low Density Lipoprotein Cholesterol (LDL) | Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in Total Cholesterol (TC) | Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks | 
| Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) | Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16 weeks | 
| Lower Limb Bone Mineral Density Between Groups | Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention | 16 weeks | 
| Lower Limb Bone Mineral Content Between Groups | Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention | 16 weeks | 
| Triglycerides Between Groups | Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention | 16 weeks | 
| High Density Lipoprotein Cholesterol (HDL) Between Groups | Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention | 16 weeks | 
| Low Density Lipoprotein Cholesterol (LDL) Between Groups | Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention | 16 weeks | 
| Total Cholesterol (TC) Between Groups | Comparison of TC between the ACE and FESLCE groups following the 16 week intervention | 16 weeks | 
| Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups | Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Composition, Exercise, Glucose Tolerance, Insulin Sensitivity, Functional Electric Stimulation