Exercise to Reduce Obesity in Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT00270855
• Recruitment Status: Completed
• First Posted: December 28, 2005
• Results First Posted: November 17, 2017
• Last Update Posted: November 17, 2017
• Sponsor: VA Office of Research and Development
• Collaborator: National Center for Research Resources (NCRR)
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Obesity; Paraplegia; Quadriplegia; Spinal Cord Injury	Procedure: Arm Crank Ergometry; Procedure: FES Cycle Ergometer	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exercise to Reduce Obesity in Spinal Cord Injury
• Study Start Date: May 2008
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. Change in % Body Fat [ Time Frame: 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.
2. Change in Fat Mass [ Time Frame: 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.
3. Change in Fat-Free Mass [ Time Frame: baseline, 16 weeks ]
   Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
4. Change in Glucose Effectiveness (Sg) [ Time Frame: Baseline, 16-weeks ]
   Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
5. Change in Insulin Sensitivity (Si) [ Time Frame: Baseline, 16-weeks ]
   Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
6. %Body Fat Between Groups [ Time Frame: 16 weeks ]
   Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
7. Fat Mass Between Groups [ Time Frame: 16 weeks ]
   Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
8. Fat Free Mass Between Groups [ Time Frame: 16 weeks ]
   Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
9. Insulin Sensitivity (Si) Between Groups [ Time Frame: 16 weeks ]
   Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
10. Glucose Effectiveness (Sg) Between Groups [ Time Frame: 16 weeks ]
    Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.

Secondary Outcome Measures :

1. Change in Lower Limb Bone Mineral Density [ Time Frame: 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.
2. Change in Lower Limb Bone Mineral Content [ Time Frame: 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.
3. Change in Triglycerides [ Time Frame: 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.
4. Change in High Density Lipoprotein Cholesterol (HDL) [ Time Frame: 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.
5. Change in Low Density Lipoprotein Cholesterol (LDL) [ Time Frame: 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.
6. Change in Total Cholesterol (TC) [ Time Frame: 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.
7. Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) [ Time Frame: 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.
8. Lower Limb Bone Mineral Density Between Groups [ Time Frame: 16 weeks ]
   Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention
9. Lower Limb Bone Mineral Content Between Groups [ Time Frame: 16 weeks ]
   Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention
10. Triglycerides Between Groups [ Time Frame: 16 weeks ]
    Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention
11. High Density Lipoprotein Cholesterol (HDL) Between Groups [ Time Frame: 16 weeks ]
    Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention
12. Low Density Lipoprotein Cholesterol (LDL) Between Groups [ Time Frame: 16 weeks ]
    Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention
13. Total Cholesterol (TC) Between Groups [ Time Frame: 16 weeks ]
    Comparison of TC between the ACE and FESLCE groups following the 16 week intervention
14. Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups [ Time Frame: 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

Other Outcome Measures:

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Virginia

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States, 23249

Sponsors and Collaborators

VA Office of Research and Development

National Center for Research Resources (NCRR)

Investigators

• Principal Investigator: David R Gater, MD PhD MS; Hunter Holmes McGuire VA Medical Center

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00270855
• Other Study ID Numbers: B3918-R; UL1RR031990 ( U.S. NIH Grant/Contract )
• First Posted: December 28, 2005
• Results First Posted: November 17, 2017
• Last Update Posted: November 17, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:

Body Composition; Exercise; Glucose Tolerance; Insulin Sensitivity; Functional Electric Stimulation

Additional relevant MeSH terms:

Spinal Cord Injuries; Paraplegia; Quadriplegia; Obesity; Wounds and Injuries; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Paralysis; Neurologic Manifestations