Exercise Training to Reduce Claudication: Arm Ergometry Versus Treadmill Walking

减少跛行的运动训练：手臂测力与跑步机步行

• 批准号: 7817011
• 负责人: DIANE J TREATJACOBSON
• 金额: $ 70.49万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7817011
• 关键词: Activities of Daily Living; Aerobic; Aerobic Exercise; Affect; American; Biological Availability; Blood Pressure; Blood flow; Cardiac Output; Cardiovascular Physiology; Cardiovascular system; Clinical; Clinical Trials; Communities; Data; Development; Diabetes Mellitus; Disease; Effectiveness; Elderly; Ergometry; Evaluation; Exercise; Functional disorder; Future; Generations; Goals; Health; Health Status; Heart failure; Human Resources; Individual; Inflammation; Inflammatory Response; Intervention; Intervention Studies; Ischemia; Laboratories; Leg; Limb structure; Link; Lower Extremity; Measures; Metabolic; Methods; Minority; Modality; Moods; Morbidity - disease rate; Nitric Oxide; Outcome; Oxygen Consumption; Pain; Pain in lower limb; Pain-Free; Participant; Patients; Peripheral arterial disease; Persons; Physical Function; Physiological; Pilot Projects; Plethysmography; Population; Positioning Attribute; Protocols documentation; Publishing; Quality of life; Recommendation; Recruitment Activity; Regimen; Relative (related person); Research; Rest; Risk; Sampling; Skeletal Muscle; Smoking; Symptoms; Testing; Therapeutic; Time; Training; Training Programs; Translating; Upper Extremity; Vasodilation; Venous; Walking; Weight-Bearing state; Woman; Work; arm; base; claudication; conditioning; design; experience; follow-up; functional outcomes; functional status; improved; improved functioning; innovation; men; mortality; multidisciplinary; novel strategies; novel therapeutics; population based; programs; response; success; theories; treatment as usual; vascular factor

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.

描述（由申请人提供）：外周动脉疾病（PAD）导致腿部血流不足，从而导致衰弱、活动诱发的缺血性疼痛（跛行）。在美国，跛行影响着超过 400 万人，典型患者在疼痛开始前只能行走 2 个街区，相关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对于改善步行距离和功能状态非常有效，普遍的理论认为训练反应是下肢骨骼肌适应的结果。尽管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）会降低可耐受的运动训练的持续时间和强度，从而限制心血管系统的调节。步行运动还可能导致缺血引起的短期炎症反应。有氧手臂测功，不会引起下肢缺血和相关疼痛，因而可以使患者实现更大量的运动训练，从而产生更大的心血管调理潜力。显然需要确定改善跛行男性和女性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。由于历史上患有跛行的女性在运动训练研究中的代表性不足；目前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 150 名患有跛行的男性和女性在立即随访（12 周）和短期随访（24 周）中，与“常规护理”（对照）相比，12 周有氧手臂运动训练与跑步机运动训练对无痛步行距离 (PFWD) 和最大步行距离 (MWD) 的相对功效，并根据无监督运动、吸烟和糖尿病状况进行调整； 2) 确定手臂测力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) 确定手臂测力或跑步机训练与“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。步行距离、心血管功能、肢体血流量以及健康和功能状态的评估将在基线、训练 6 周和 12 周后以及 12 周随访（24 周）后进行。假设 1) 与对照组参与者相比，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果方面将表现出类似的卓越改善； 2）生理指标的改善将与步行距离的改善相关。这将为将运动训练的临床结果与特定的生理因素联系起来提供证据，为未来的研究确定该人群的最佳运动干预提供方向。公众相关性：外周动脉疾病影响着超过 800 万美国人，并与显着的发病率、死亡率和虚弱有关，包括活动引起的腿部疼痛（跛行）。使用跑步机行走进行监督运动训练虽然很痛苦，但可以有效减少跛行，使跛行患者能够在较少疼痛的情况下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行走能力的功效。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替代方案。