Exercise to Reduce Obesity in Spinal Cord Injury

Not Applicable

Completed

Conditions: Obesity
Diabetes Mellitus
Paraplegia
Spinal Cord Injury
Quadriplegia

Interventions: Procedure: Arm Crank Ergometry
Procedure: FES Cycle Ergometer

Registration Number: NCT00270855

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Crank Ergometer	Arm Crank Ergometry	Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
FESLCE	FES Cycle Ergometer	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

Primary Outcome Measures

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

Secondary Outcome Measures

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