Home-based vs. Supervised Exercise for Claudicants

描述(由申请者提供)：广泛的、长期的目标。通过确定是否可以使用家庭锻炼来治疗症状，对间歇性跛行的PAD患者的临床治疗产生重大影响。基本原理。与有监督的锻炼计划相比，由于先前试验的研究方法存在严重缺陷，人们对间歇性跛行的PAD患者的家庭锻炼知之甚少。明确的目标。(1)本试验将比较间歇性跛行患者在接受家庭运动康复方案、监督运动方案和进行轻度抵抗训练的注意对照组后的步行功能、血管功能和与健康相关的生活质量的变化，以及(2)确定步行经济、小腿肌肉循环和小腿肌肉氧合的变化是否是家庭运动康复和监督运动康复改善步行功能的主要生理机制。研究设计与方法。一项前瞻性随机对照临床试验将比较在家锻炼组(N=37)、监督运动组(N=37)和注意力控制组(N=37)。这两个运动计划将在训练期间的估计卡路里消耗上相匹配。为期3个月的监督计划将包括每周3次分级跑步机步行，而3个月的居家计划将包括每周3次基于社区的步行。居家组的步行时间会更长，因为步行的强度会低于监管组。运动量的匹配将使用新技术(Step活动监测器)来准确记录长达一个月的每分钟一分钟的社区步行，然后在家庭训练期间根据节奏滴定每个患者的卡路里消耗。注意对照组患者在不进行任何步行训练的情况下进行耐光训练。临床意义。这项随机对照临床试验将支持这样一个概念，即家庭锻炼可以用于治疗间歇性跛行的PAD患者，并将推广到绝大多数无法获得监督锻炼计划的患者，但他们可以在临床医生最少干预和资源使用最少的情况下受益于家庭步行计划。

DESCRIPTION (provided by applicant): Broad, Long-Term Objective. To make a significant impact in the clinical management of PAD patients with intermittent claudication by determining whether home-based exercise can be used to treat symptomatology. Rationale. In contrast to supervised exercise programs, home-based exercise for PAD patients with intermittent claudication is poorly understood due to serious flaws in the research approach of previous trials. Specific Aims. (1) This trial will compare the changes in ambulatory function, vascular function, and health- related quality of life in PAD patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and an attention-control group who perform light resistance training exercise, and (2) to determine whether changes in walking economy, calf muscle circulation, and calf muscle oxygenation are the major physiologic mechanisms by which both home-based and supervised exercise rehabilitation improve ambulatory function. Research Design and Methods. A prospective, randomized controlled clinical trial will compare a home-based exercise group (N = 37), a supervised exercise group (N = 37), and an attention-control group (N = 37). The two exercise programs will be matched on the estimated caloric expenditure during the training sessions. The 3-month supervised program will consist of graded treadmill walking 3 times per week, and the 3-month home-based program will consist of community-based walking 3 times per week. Walking duration will be longer for the home-based group because the intensity of walking will be lower than the supervised group. Matching on volume of exercise will be done using new technology (step activity monitor) to accurately record community-based ambulation on a minute-to-minute basis for up to a month, and then titrating the caloric expenditure against cadence for each patient during the home-based training sessions. Patients in the attention-control group will perform light-resistance training without any walking exercise. Clinical Significance. This randomized controlled clinical trial will support the notion that home-based exercise can be used to treat PAD patients with intermittent claudication, and will be generalizable to the vast majority of patients who do not have access to a supervised exercise program, but who can benefit from a home-based walking program with minimal intervention from clinicians and minimal use of resources.