Exercise to Reduce Obesity in Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus; Spinal Cord Injury; Quadriplegia; Paraplegia
• Intervention / Treatment: Procedure: Arm Crank Ergometry; Procedure: FES Cycle Ergometer

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm Crank Ergometer; 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; 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
Other: FESLCE; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Resting Metabolic Rate	Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.	baseline, 16 weeks
Resting Metabolic Rate Between Groups	Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention	16 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: David R Gater, MD PhD MS, Hunter Holmes McGuire VA Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 23, 2005
• First Submitted That Met QC Criteria: December 23, 2005
• First Posted (Estimate): December 28, 2005

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Body Composition; Insulin Sensitivity; Glucose Tolerance; Functional Electric Stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Obesity; Wounds and Injuries; Spinal Cord Injuries; Quadriplegia; Paraplegia
• Other Study ID Numbers: B3918-R; UL1RR031990 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO