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Exercise to Reduce Obesity in Spinal Cord Injury

Primary Purpose

Diabetes Mellitus, Obesity, Paraplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm Crank Ergometry
FES Cycle Ergometer
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Body Composition, Exercise, Glucose Tolerance, Insulin Sensitivity, Functional Electric Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm Crank Ergometer

FESLCE

Arm Description

Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks

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

Outcomes

Primary Outcome Measures

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.
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.
Change in Fat-Free Mass
Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
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.
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.
%Body Fat Between Groups
Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
Fat Mass Between Groups
Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
Fat Free Mass Between Groups
Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
Insulin Sensitivity (Si) Between Groups
Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
Glucose Effectiveness (Sg) Between Groups
Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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
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
Triglycerides Between Groups
Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention
High Density Lipoprotein Cholesterol (HDL) Between Groups
Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention
Low Density Lipoprotein Cholesterol (LDL) Between Groups
Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention
Total Cholesterol (TC) Between Groups
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
Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention

Full Information

First Posted
December 23, 2005
Last Updated
October 13, 2017
Sponsor
VA Office of Research and Development
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00270855
Brief Title
Exercise to Reduce Obesity in Spinal Cord Injury
Official Title
Exercise to Reduce Obesity in Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Obesity, Paraplegia, Quadriplegia, Spinal Cord Injury
Keywords
Body Composition, Exercise, Glucose Tolerance, Insulin Sensitivity, Functional Electric Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Crank Ergometer
Arm Type
Other
Arm Description
Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
Arm Title
FESLCE
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Arm Crank Ergometry
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
FES Cycle Ergometer
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in % Body Fat
Description
Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
baseline, 16 weeks
Title
Change in Fat Mass
Description
Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
Baseline, 16 Weeks
Title
Change in Fat-Free Mass
Description
Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
baseline, 16 weeks
Title
Change in Glucose Effectiveness (Sg)
Description
Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
Baseline, 16-weeks
Title
Change in Insulin Sensitivity (Si)
Description
Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
Baseline, 16-weeks
Title
%Body Fat Between Groups
Description
Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
Time Frame
16 weeks
Title
Fat Mass Between Groups
Description
Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
Time Frame
16 weeks
Title
Fat Free Mass Between Groups
Description
Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
Time Frame
16 weeks
Title
Insulin Sensitivity (Si) Between Groups
Description
Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
Time Frame
16 weeks
Title
Glucose Effectiveness (Sg) Between Groups
Description
Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in Lower Limb Bone Mineral Density
Description
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.
Time Frame
baseline, 16 weeks
Title
Change in Lower Limb Bone Mineral Content
Description
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.
Time Frame
baseline, 16 weeks
Title
Change in Triglycerides
Description
Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
baseline, 16 weeks
Title
Change in High Density Lipoprotein Cholesterol (HDL)
Description
Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
baseline, 16 weeks
Title
Change in Low Density Lipoprotein Cholesterol (LDL)
Description
Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
baseline, 16 weeks
Title
Change in Total Cholesterol (TC)
Description
Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
baseline, 16 weeks
Title
Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)
Description
Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
Baseline, 16 weeks
Title
Lower Limb Bone Mineral Density Between Groups
Description
Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks
Title
Lower Limb Bone Mineral Content Between Groups
Description
Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks
Title
Triglycerides Between Groups
Description
Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks
Title
High Density Lipoprotein Cholesterol (HDL) Between Groups
Description
Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks
Title
Low Density Lipoprotein Cholesterol (LDL) Between Groups
Description
Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks
Title
Total Cholesterol (TC) Between Groups
Description
Comparison of TC between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks
Title
Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups
Description
Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Change in Resting Metabolic Rate
Description
Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame
baseline, 16 weeks
Title
Resting Metabolic Rate Between Groups
Description
Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Gater, MD PhD MS
Organizational Affiliation
Hunter Holmes McGuire VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise to Reduce Obesity in Spinal Cord Injury

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