Exercise Training to Reduce Claudication: Arm Ergometry Versus Treadmill Walking

描述（由申请人提供）：外周动脉疾病（PAD）导致腿部血流不足，导致活动诱导的缺血性疼痛（跛行）。在美国，跛行影响超过400万人，并且在疼痛开始之前将典型患者的行走限制为2个街区，相关的功能能力与严重心力衰竭患者相似。跑步机运动训练已被证明在改善步行距离和功能状态方面非常有效，流行的理论认为训练反应是下肢骨骼肌适应的结果。虽然步行运动可能会刺激局部骨骼肌的变化，但缺血性疼痛（跛行）会减少运动训练的持续时间和强度，从而限制心血管系统的调节。步行运动也可能导致缺血诱导的短期炎症反应。有氧手臂测力计，不会引起下肢缺血和相关疼痛，因此可能使患者实现更大的运动训练量，从而产生更大的心血管调理潜力。有一个明确的需要，以确定最佳的训练方案，以改善男性和女性跛行步行距离，并确定不同的运动方式对选定的因素，影响改善的效果。由于历史上跛行女性在运动训练研究中的代表性不足，因此尚不清楚男性和女性对运动训练的反应是否不同。本研究的目的是：1）确定12周有氧臂与跑步机运动训练的相对疗效，与"常规护理"相比，（对照组），在150名男性和女性跛行患者中，立即进行无疼痛步行距离（PFWD）和最大步行距离（MWD）（12周）和短期随访（24周），调整无监督运动，吸烟和糖尿病状态;（二）确定手臂测力计与跑步机运动训练对心肺和血管因素的相对有效性，这些因素有助于步行距离的改善; 3）确定手臂测力计或跑步机训练与"常规护理"对健康和功能结果的相对功效; 4）独立评估男性和女性对运动训练的反应。将在基线、6周和12周训练后以及12周随访（24周）后评估步行距离、心血管功能、肢体血流以及健康和功能状态。假设1）与对照参与者相比，接受上肢或下肢有氧训练的参与者在步行距离以及健康和功能结局方面将显示出相似的上级改善; 2）生理指标的改善将与步行距离的改善相关。这将提供证据，将运动训练的临床结果与特定的生理因素联系起来，为未来的研究提供方向，以确定该人群的最佳运动干预。公众相关性：外周动脉疾病影响超过800万美国人，并且与显著的发病率、死亡率和虚弱（包括活动引起的腿部疼痛（跛行））相关。使用跑步机行走的监督运动训练虽然疼痛，但可有效减少跛行，使跛行患者能够完成日常活动，包括行走，疼痛减轻。这项研究将确定有氧手臂锻炼对减轻跛行症状和改善步行能力的疗效。如果有效的话，这种类型的运动将为跛行患者提供一种无痛的治疗性运动。

DESCRIPTION (provided by applicant): Peripheral arterial disease (PAD) causes insufficient blood flow to the legs, which results in debilitating, activity-induced, ischemic pain (claudication). Claudication affects over 4 million individuals in the USA and limits the typical patient to walking = to 2 blocks before pain begins, with an associated functional capacity similar to that of patients with severe heart failure. Treadmill exercise training has been shown to be very effective at improving walking distance and functional status, with the prevailing theory that the training response is a result of adaptation in the lower extremity skeletal muscles. Although walking exercise may stimulate local skeletal muscle changes, ischemic pain (claudication) reduces the duration and intensity of exercise training tolerated, thus limiting conditioning of the cardiovascular system. Walking exercise also may result in ischemia-induced, short-term inflammatory responses. Aerobic arm ergometry, does not cause lower limb ischemia and associated pain, and thus may enable patients to achieve a greater amount of exercise training, resulting in a greater potential for cardiovascular conditioning. There is a clear need to determine the optimal training regimen for improving walking distance in men and women with claudication and to determine the effects of different exercise modalities on selected factors that influence improvement. Since women with claudication have historically been underrepresented in exercise training studies; it is not known whether the response to exercise training differs between men and women. The purpose of this study is to 1) Determine the relative efficacy of 12 weeks of aerobic arm versus treadmill exercise training, as compared to "usual care" (controls), on pain free walking distance (PFWD) and maximal walking distance (MWD), in 150 men and women with claudication, at immediate (12 weeks) and short-term follow-up (24 weeks), adjusting for unsupervised exercise, smoking, and diabetes status; 2) Determine the relative effectiveness of arm ergometry versus treadmill exercise training on cardiorespiratory and vascular factors that contribute to improvement in walking distance; 3) Determine the relative efficacy of arm ergometry or treadmill training versus "usual care" on health and functional outcomes; 4) Evaluate the response to exercise training independently for men and women. Assessments of walking distance, cardiovascular function, limb blood flow, and health and functional status will occur at baseline, after 6 and 12 weeks of training, and after 12 weeks of follow-up (24 weeks). It is hypothesized that 1) participants undergoing upper or lower extremity aerobic training will show similar superior improvement in walking distances and health and functional outcomes in comparison to control participants in walking distances as well as health and functional outcomes; and that 2) improvements in physiologic measures will be associated with improvements in walking distance. This will provide evidence to link the clinical outcomes seen with exercise training to specific physiologic factors, providing direction for future studies to determine the optimal exercise intervention in this population. PUBLIC RELEVANCE: Peripheral arterial disease affects more than 8 million Americans and is associated with significant morbidity, mortality, and debilitation, including activity-induced leg pain (claudication). Supervised exercise training using treadmill walking, although painful, is effective at reducing claudication, allowing persons with claudication to complete daily activities, including walking, with less pain. This study will determine the efficacy of aerobic arm exercise to reduce symptoms of claudication and improve walking ability. If effective, this type of exercise would offer a pain free therapeutic exercise alternative for individuals with claudication.