Polestriding versus Walking for PAD Rehabilitation

描述（由申请人提供）：外周动脉疾病（PAD）是一种使人衰弱的疾病，影响美国800万至1200万人。下肢PAD患者会出现间歇性跛行疼痛。PAD患者报告了步态变化，如步长、步频和步行速度降低。步行锻炼已被规定为PAD患者康复治疗的主要模式。已发现一种增强形式的步行运动，即撑杆跳，可改善PAD患者的康复结果。用杆子走路还可以增加步幅、步频和步行速度，并减少关节上的地面反作用力。步行杆使用后的步行力学变化可能会使腿部肌肉有更多的时间灌注，从而延迟缺血性疼痛的发作并降低其严重程度。因此，我们推测，在PAD患者的康复中，撑杆跳可能上级于步行锻炼。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：主要的具体目的是比较PAD患者24周步行与撑杆跳运动对运动耐力、感知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机制，以解释在撑杆跳和步行组中观察到的预期差异。机制变量包括感觉到的跛行疼痛、步态生物力学、最严重受累腿部的组织氧合和日常体力活动。设计：采用随机、对照的临床试验，比较撑杆跳和步行运动的效果。本研究将入组180例患者，随机分配126例患者（每组n=63）。基线测试将包括跑步机运动、完成功能评估问卷、步态分析和身体活动测量。然后，受试者将被随机分配到24周的步行或撑杆跳计划。受试者每周锻炼三次，每次30-60分钟。运动的持续时间和强度将系统地增加。将在第6、12和24周对受试者进行复检。最后一组测试将在32周时完成，以评估受试者保持健身效果的情况。分析：将使用描述性统计、重复测量ANOVA和线性回归分析分析数据。将监测和分析潜在的协变量，如吸烟和药物使用。

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.