| City: |
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Richmond |
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State:
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VA |
| Zip Code: |
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23249 |
| Conditions: |
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Diabetes Mellitus - Obesity - Paraplegia - Quadriplegia - Spinal Cord Injury |
| Purpose: |
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The purpose of this proposal is to evaluate and compare the health benefits of using upper
extremity exercise versus functional electrical stimulation for lower extremity exercise.
It is our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES
LCE) exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise will 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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| Study summary: |
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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 are 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 will be 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 will be 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 will be provided similar nutritional assessments and intervention.
Exercise training will consist 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 4-compartment modeling, visceral adiposity, insulin sensitivity, glucose
effectiveness, lipid profiles, and lower extremity bone mineral density (BMD) will be
determined before and after 16-week exercise interventions. |
| Criteria: |
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Inclusion Criteria:
Criteria for participation will include 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 are unresponsive to surface neurostimulation, have 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 will be excluded from the
study. Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within
3 months) deep vein thrombosis, or pressure ulcers > Grade II will be excluded. |
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| Study is available at: |
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Hunter Holmes McGuire VA Medical Center
Richmond, VA 23249
United States
Primary Contact:
Jonathan Daniels, BS
Email: jonathan.daniels@va.gov
Phone: 804-675-6200
Secondary Contact:
Jonathan Daniels, BS
Email: jonathan.daniels@va.gov
Phone: (804) 675-6200 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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