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，在美国影响着800万至1200万人。下肢PAD患者会出现间歇性跛行疼痛。据报道，PAD患者的步态改变，如步幅、节奏和步行速度减少。步行运动已被规定为PAD患者康复治疗的主要模式。一种增强形式的步行运动，骑杆子，已经被发现可以改善PAD患者的康复结果。拄着拐杖走路还可以增加步幅、节奏和行走速度，减少关节上的地面反作用力。使用步行杆后继发的行走力学变化可能允许更多时间灌注腿部肌肉，从而延迟缺血性疼痛的发作并降低其严重程度。因此，我们假设在PAD患者的康复中，骑杆子可能优于步行运动。然而，这两种疗法从未在该人群的随机试验中进行过比较。具体目的：主要的具体目的是比较PAD患者进行24周步行和跨极运动对运动耐力、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，以解释在骑极组和步行组中观察到的预期差异。机制变量包括感知的跛行疼痛、步态生物力学、受影响最严重的腿的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杆子和步行锻炼的效果。180例患者将被纳入研究，随机分配126例（每组63例）。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一个为期24周的步行或骑杖项目中。受试者将每周锻炼三次，每次30-60分钟。系统地增加运动的时间和强度。受试者将在第6周、第12周和第24周重新接受测试。最后一组测试将在32周时完成，以评估受试者保持健康的程度。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.