Polestriding versus Walking for PAD Rehabilitation

描述(申请人提供)：外周动脉疾病(PAD)是一种使人衰弱的疾病，在美国有800万到1200万人受到影响。患有PAD的患者会出现间歇性跛行疼痛。据报道，患有PAD的患者步态发生变化，如步幅、节奏和行走速度减少。步行锻炼已被指定为PAD患者的主要康复治疗模式。研究发现，一种增强的步行运动形式--骑马--可以改善PAD患者的康复结果。用扁担行走还可以增加步幅、节奏和行走速度，并减少关节上的地面反作用力。在使用电线杆后，改变行走机制可能会有更多的时间对腿部肌肉进行灌流，从而延缓和减轻缺血性疼痛的发生和程度。因此，我们假设，在PAD患者的康复中，骑马可能优于步行锻炼。然而，这两种疗法从未在该人群的随机试验中进行过比较。具体目标：主要的具体目标是比较24周步行和骑马运动对PAD患者运动耐力、感觉到的身体功能和步行能力的影响。第二个目的是探索生物力学和生理学机制，以解释在骑马和步行两组中观察到的预期差异。力学变量包括感觉到的跛行疼痛、步态生物力学、受影响最严重的腿部组织氧合和日常体力活动。设计：一项随机对照临床试验将用于比较骑马和步行锻炼的效果。180名患者将被纳入这项研究，随机选择126名患者(每组63名)。基线测试将包括跑步机运动、完成功能评估问卷、步态分析和体力活动测量。然后，受试者将被随机安排参加为期24周的步行或骑马计划。受试者每周锻炼三次，每次30-60分钟。有计划地增加锻炼的持续时间和强度。受试者将在6周、12周和24周重新测试。最后一组测试将在32周内完成，以评估受试者保持健康增长的情况。分析：数据将使用描述性统计、重复测量方差分析和线性回归分析进行分析。潜在的协变量，如吸烟和药物使用，将被监测和分析。

DESCRIPTION (provided by applicant): Peripheral arterial disease (PAD) is a debilitating condition affecting between 8 and 12 million people in the United States. Patients with PAD of the lower extremities are subject to periods of intermittent claudication pain. Gait changes such as reduced stride length, cadence and walking speed are reported in patients with PAD. Walking exercise has been prescribed as the primary mode of rehabilitative treatment in patients with PAD. An enhanced form of walking exercise, polestriding, has been found to improve rehabilitation outcomes for patients with PAD. Walking with poles also increases stride length, cadence and walking speed and decreases ground reaction forces on the joints. Changes in walking mechanics secondary to walking pole use may allow more time for perfusion of the leg muscles thus delaying the onset of and decreasing the severity of ischemic pain. Thus, we hypothesize that polestriding may be superior to walking exercise in the rehabilitation of persons with PAD. The two therapies however, have never been compared in a randomized trial in this population. Specific Aims: The primary specific aim is to compare the effects of a 24-week walking versus polestriding exercise in patients with PAD on exercise endurance, perceived physical function and walking abilities. The secondary aim is to explore biomechanical and physiologic mechanisms to explain the expected differences observed in the polestriding and walking groups. Mechanistic variables include perceived claudication pain, gait biomechanics, tissue oxygenation in the most severely affected leg and daily physical activity. Design: A randomized, controlled clinical trial will be used to compare the effects of polestriding and walking exercise. 180 patients will be enrolled in the study to randomize 126 (n=63 in each group). Baseline testing will consist of treadmill exercise, completion of functional assessment questionnaires, gait analysis, and physical activity measurement. Subjects will then be randomized to a 24-week walking or polestriding program. Subjects will exercise three times weekly for 30-60 minutes. Duration and intensity of exercise will be systematically increased. Subjects will be re-tested at 6, 12, and 24 weeks. A final testing battery will be completed at 32 weeks to assess how well subjects have maintained fitness gains. Analysis: Data will be analyzed using descriptive statistics, repeated measures ANOVA and linear regression analysis. Potential co-variates such as smoking and medication use will be monitored and analyzed.