Problem: There are an estimated 1.2 million persons in the United States with spinal cord injury (SCI) or dysfunction and recent literature would imply that more than 2/3 are overweight or obese by BMI standards, and more than 50% of them are glucose intolerant, with one out of five is frankly diabetic. This special population already has significant functional deficits including reduced mobility, myocardial atrophy, neurogenic lung dysfunction, bowel and bladder dysfunction, and a high risk for skin breakdown. The additional deficits of visual impairment, gastroparesis, renal disease, peripheral polyneuropathy, and impaired wound healing associated with obesity and diabetes impacts independence to a much greater extent in spinal cord injured (SCI) than in the able-bodied population.
Specific Aims : The specific objectives for the current proposal are to assess the impact of Home-based functional electrical stimulation leg-cycle exercise HBFES LCE + Diet versus Diet Alone on (Primary Variables) body composition (%Body Fat, Fat Mass and Fat-Free Mass), insulin sensitivity(SI), glucose effectiveness (SG), and Basal Metabolic Rate (BMR), as well as (Secondary Variables) lower extremity bone mineral density (BMD), lipid profiles, and hsCRP in adults with motor complete SCI between C4-T4. Methods: Forty 18-65 y.o. individuals with C4-T4 motor complete (AIS A&B) spinal cord injury will be recruited over 48 months to participate in a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week telemonitored exercise and/or diet intervention on selected fitness parameters in adults with SCI. Primary outcome measures will include body composition assessment, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include BMD, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE plus Diet on an RT300 ergometer (Restorative Therapeutics, Inc., Baltimore, MD) or Diet Alone intervention as determined by a random number generator. Impact: The potential to reverse and prevent obesity, diabetes and heart disease in this population has tremendous implications on quality of life and reduced health care costs. Further, the ?side-effects? associated with exercise and diet intervention, including improved cardiovascular fitness, improved cholesterol profiles, improved functional mobility, reduced body fat, improved gastric motility, and reduced spasticity will also positively impact the SCI person's ability to maintain a greater degree of independence and contribute longer to the work force and society. Home-based telemonitored Exercise and Diet to reduce obesity has tremendous potential, therefore, to improve health and quality of life, while reducing health care costs for persons with high paraplegia and tetraplegia.
?Neurogenic obesity? results from the obligatory sarcopenia, blunted anabolism, blunted sympathetic nervous system responses and the positive energy balance associated with spinal cord injury (SCI). The majority of persons with SCI are dangerously obese and subsequently at high risk for the metabolic syndrome of obesity, hypertension, dyslipidemia, diabetes and vascular inflammation. Functional electrical stimulation (FES) exercise of the lower extremities in addition to diet has the capacity to increase lower extremity muscle mass and metabolic activity such that energy expenditure can be increased and body fat reduced. The capacity to provide home-based, tele-monitored, diet and FES exercise in the person's own home without leaving his/her wheelchair will allow those with SCI to overcome the usual barriers to exercise and dietary compliance (travel, inaccessible equipment, time and environmental constraints), opening the door to one of the most exciting, game-changing and important metabolic interventions available to this vulnerable population in decades.
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