Home-based vs. Supervised Exercise for Claudicants

跛行者在家锻炼与监督锻炼

• 批准号: 7279455
• 负责人: Andrew W Gardner
• 金额: $ 29.16万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7279455
• 关键词: Activities of Daily Living; Address; Adherence; Adopted; Affect; Age-Years; Attention; Blood Circulation; Blood Vessels; Blood flow; Buttocks; Clinical Management; Clinical Trials Design; Communities; Control Groups; Controlled Clinical Trials; Daily; Data Reporting; Elderly; Equilibrium; Event; Exercise; Expenditure; Functional disorder; Gait; Goals; High Prevalence; Home environment; Intermittent Claudication; Intervention; Life Style; Light; Lower Extremity; Measures; Mediating; Methods; Monitor; Morbidity - disease rate; Muscle; Numbers; Older Population; Outcome; Pain; Patients; Peripheral; Peripheral arterial disease; Physical Function; Physical activity; Physiological; Protocols documentation; Publishing; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Rehabilitation therapy; Research; Research Design; Research Personnel; Resistance; Resources; Sample Size; Standards of Weights and Measures; Technology; Therapeutic; Thigh structure; Time; Training; Treadmill Tests; Walking; Week; base; claudication; clinically significant; design; disorder control; falls; functional status; health related quality of life; improved; new technology; programs; prospective; sedentary

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.

描述（由申请人提供）：广泛，长期目标。通过确定家庭运动是否可以用于治疗症状，对伴有间歇性跛行的PAD患者的临床管理产生重大影响。基本原理。与有监督的运动计划相比，由于先前试验的研究方法存在严重缺陷，人们对伴有间歇性跛行的PAD患者的家庭运动知之甚少。具体的目标。(1)本试验将比较受间歇性跛行限制的PAD患者在接受基于家庭的运动康复计划、有监督的运动计划和进行轻度阻力训练的注意力控制组后，其运动功能、血管功能和健康相关生活质量的变化。(2)确定步行经济性、小腿肌肉循环、小腿肌肉氧合是家庭运动康复和监督运动康复改善运动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家庭锻炼组（N = 37）、监督锻炼组（N = 37）和注意力控制组（N = 37）。这两个运动项目将在训练过程中根据估计的卡路里消耗进行匹配。为期3个月的监督计划将包括每周3次分级跑步机步行，为期3个月的家庭计划将包括每周3次社区步行。居家组的步行时间会更长，因为步行的强度会比监督组低。将使用新技术（步数活动监测仪）进行运动量匹配，以准确记录长达一个月的基于社区的每分钟走动情况，然后在家庭训练期间根据每个患者的节奏滴定卡路里消耗。注意力控制组的患者将在没有任何步行运动的情况下进行光阻力训练。临床意义。这项随机对照临床试验将支持家庭运动可用于治疗伴有间歇性跛行的PAD患者的观点，并将推广到绝大多数无法获得监督运动计划的患者，但他们可以从家庭步行计划中受益，临床医生的干预最少，资源的使用最少。