Exercise Training to Reduce Claudication: Arm Ergometry Versus Treadmill Walking

描述(申请人提供)：外周动脉疾病(PAD)导致腿部血流不足，导致虚弱、活动诱发的缺血性疼痛(跛行)。在美国，跛行影响着400多万人，在疼痛开始之前，典型的患者只能行走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腿部骨骼肌适应的结果。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)会减少耐受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。有氧手臂测功术不会引起肢体缺血和相关疼痛，因此可能使患者获得更多的运动训练，从而产生更大的心血管调节潜力。显然需要确定改善跛行男女步行距离的最佳训练方案，并确定不同运动方式对影响改善的选定因素的影响。由于跛行妇女在运动训练研究中的代表性历来偏低；尚不清楚男女对运动训练的反应是否有所不同。本研究的目的是：1)在150名跛行的男性和女性的即刻(12周)和短期随访(24周)时，确定12周的手臂有氧运动训练与跑步机运动训练(对照)相比对无痛步行距离(PFWD)和最大步行距离(MWD)的相对有效性；2)确定手臂测功器与跑步机运动训练对有助于改善步行距离的心肺和血管因素的相对有效性；3)确定手臂测功器或跑步机训练与“常规护理”对健康和功能结果的相对有效性；4)独立评估男性和女性对运动训练的反应。对步行距离、心血管功能、肢体血流以及健康和功能状态的评估将在基线、6周和12周训练后以及12周(24周)随访后进行。假设1)接受上肢或下肢有氧训练的参与者在步行距离、健康和功能结果方面与对照组参与者相比将表现出类似的更好的改善；以及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，为未来的研究确定这一人群的最佳运动干预提供方向。公众关注：外周动脉疾病影响了800多万美国人，并与严重的发病率、死亡率和虚弱有关，包括活动引起的腿部疼痛(跛行)。使用跑步机步行的监督运动训练虽然痛苦，但在减少跛行方面是有效的，使跛行的人能够以较少的疼痛完成包括步行在内的日常活动。这项研究将确定有氧手臂运动对减轻跛行症状和提高步行能力的效果。如果有效，这种类型的运动将为跛行患者提供一种无痛的治疗运动替代方案。

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.