Home-based vs. Supervised Exercise for Claudicants

描述（由申请人提供）：广泛的，长期的目标。通过确定家庭运动是否可用于治疗间歇性跛行的PAD患者的临床管理产生重大影响。理由。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，对间歇性跛行PAD患者的家庭锻炼了解甚少。具体目标。(1)本试验将比较间歇性跛行受限的PAD患者在接受家庭运动康复计划、监督运动计划和进行轻度阻力训练运动的注意力控制组后的步行功能、血管功能和健康相关生活质量的变化，以及（2）确定步行经济性、小腿肌肉循环、和小腿肌肉氧合是主要的生理机制，通过这些机制，基于家庭的和监督的运动康复都改善了步行功能。研究设计和方法。一项前瞻性随机对照临床试验将比较家庭锻炼组（N = 37）、监督锻炼组（N = 37）和注意力控制组（N = 37）。在训练期间，两个运动计划将根据估计的热量消耗进行匹配。3个月的监督计划将包括每周3次的分级跑步机行走，3个月的家庭计划将包括每周3次的社区行走。在家组的步行时间将更长，因为步行的强度将低于监督组。运动量的匹配将使用新技术（步进活动监测器）来精确记录长达一个月的社区运动量，然后在家庭训练课程期间根据每个患者的节奏滴定热量消耗。注意力控制组患者将进行光阻训练，不进行任何步行运动。临床意义这项随机对照临床试验将支持这样一种观点，即家庭锻炼可用于治疗间歇性跛行的PAD患者，并且将推广到绝大多数无法获得监督锻炼计划的患者，但他们可以从家庭步行计划中受益，临床医生的干预最少，资源使用最少。

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.