Exercise to Reduce Obesity in Spinal Cord Injury

Obesity Clinical Trial

Official title:

Exercise to Reduce Obesity in Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270855
• Other study ID #: B3918-R
• Secondary ID: UL1RR031990
• Status: Completed
• Phase: N/A
• First received: December 23, 2005
• Last updated: October 13, 2017
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: October 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Resting Metabolic Rate Between Groups	Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention	16 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	%Body Fat Between Groups	Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.	16 weeks
Primary	Fat Mass Between Groups	Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.	16 weeks
Primary	Fat Free Mass Between Groups	Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.	16 weeks
Primary	Insulin Sensitivity (Si) Between Groups	Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.	16 weeks
Primary	Glucose Effectiveness (Sg) Between Groups	Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.	16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Triglycerides Between Groups	Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention	16 weeks
Secondary	High Density Lipoprotein Cholesterol (HDL) Between Groups	Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention	16 weeks
Secondary	Low Density Lipoprotein Cholesterol (LDL) Between Groups	Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention	16 weeks
Secondary	Total Cholesterol (TC) Between Groups	Comparison of TC between the ACE and FESLCE groups following the 16 week intervention	16 weeks
Secondary	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