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Completed

NCT Number: NCT00270855

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.

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Key information

Conditions

Diabetes Mellitus Behavior Body Weight Central Nervous System Diseases Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arm Crank Ergometry

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 28, 2005
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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