Exercise to Reduce Obesity in Spinal Cord Injury

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Brief Title

Exercise to Reduce Obesity in Spinal Cord Injury

Official Title

Exercise to Reduce Obesity in Spinal Cord Injury

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.
    


Study Type

Interventional


Primary Outcome

Change in % Body Fat

Secondary Outcome

 Change in Lower Limb Bone Mineral Density

Condition

Diabetes Mellitus

Intervention

Arm Crank Ergometry

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

29

Start Date

May 2008

Completion Date

December 2011

Primary Completion Date

June 2011

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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

David R Gater, MD PhD MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00270855

Organization ID

B3918-R

Secondary IDs

UL1RR031990

Responsible Party

Sponsor

Study Sponsor

VA Office of Research and Development

Collaborators

 National Center for Research Resources (NCRR)

Study Sponsor

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


Verification Date

October 2017