Exercise to Reduce Obesity in Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT00270855 |
Recruitment Status :
Completed
First Posted : December 28, 2005
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Obesity Paraplegia Quadriplegia Spinal Cord Injury | Procedure: Arm Crank Ergometry Procedure: FES Cycle Ergometer | Not Applicable |
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 |

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
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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
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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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- %Body Fat Between Groups [ Time Frame: 16 weeks ]Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
- Fat Mass Between Groups [ Time Frame: 16 weeks ]Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
- 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.
- Insulin Sensitivity (Si) Between Groups [ Time Frame: 16 weeks ]Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
- Glucose Effectiveness (Sg) Between Groups [ Time Frame: 16 weeks ]Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- Triglycerides Between Groups [ Time Frame: 16 weeks ]Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention
- 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
- 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
- Total Cholesterol (TC) Between Groups [ Time Frame: 16 weeks ]Comparison of TC between the ACE and FESLCE groups following the 16 week intervention
- 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
- 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.
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270855
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | |
Richmond, Virginia, United States, 23249 |
Principal Investigator: | David R Gater, MD PhD MS | Hunter Holmes McGuire VA Medical Center |
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 Key Record Dates |
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 |
Body Composition Exercise Glucose Tolerance Insulin Sensitivity Functional Electric Stimulation |
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 |