Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

项目摘要： 问题：据估计，美国有120万人患有脊髓损伤（SCI）或 功能障碍和最近的文献暗示超过2/3的人根据BMI标准超重或肥胖， 超过50%的人是葡萄糖不耐症，五分之一的人是糖尿病患者。这个特殊 人群已经具有显著的功能缺陷，包括活动性降低、心肌萎缩、神经源性 肺功能障碍，肠和膀胱功能障碍，以及皮肤破裂的高风险。额外的赤字 视力损害、胃轻瘫、肾脏疾病、周围多发性神经病和伤口愈合受损 与肥胖和糖尿病相关的脊髓损伤在更大程度上影响了独立性 (SCI)比健全的人多。具体目标：本提案的具体目标是 评估基于家庭的功能性电刺激腿周期运动HBFES LCE +饮食的影响 与单独饮食相比，（主要变量）身体成分（%体脂、脂肪质量和无脂肪质量）、胰岛素 敏感性（SI）、葡萄糖有效性（SG）和基础代谢率（BMR）以及（次要变量） 运动完全性SCI成人下肢骨密度（BMD）、血脂和hsCRP 在C4-T4之间。方法：40例18-65岁。患有C4-T4运动完全（AIS A&B）脊髓的个体 将在48个月内招募损伤患者参加一项随机、基线对照、前瞻性 一项干预性试验，评估16周远程监测运动和/或饮食干预对 选择适合的参数与SCI的成年人。主要结果指标将包括身体成分 评估、胰岛素敏感性、血糖有效性和BMR，而次要结局将包括BMD， 在16周干预前后测定血脂谱和hsCRP。受试者将被随机 在RT 300测力计（Restorative Therapeutics，Inc.，巴尔的摩， MD）或由随机数发生器确定的单独饮食干预。影响：潜力 逆转和预防肥胖，糖尿病和心脏病在这一人群中有巨大的影响， 生活质量和降低医疗费用。此外，与运动和饮食有关的“副作用” 干预，包括改善心血管健康，改善胆固醇状况，改善功能 灵活性，减少身体脂肪，改善胃动力和减少痉挛也将积极影响SCI 一个人保持更大程度的独立性和为劳动力做出更长贡献的能力， 社会以家庭为基础的远程监测运动和饮食，以减少肥胖有巨大的潜力，因此， 改善健康和生活质量，同时降低高位截瘫患者的保健费用， 四肢瘫痪

Project Summary: 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.