【文献译读】外周动脉疾病的家庭步行运动

For approximately 30 years, supervised exercise therapy, typically consisting of walking for exercise on a treadmill at a health care facility in the presence of an exercise physiologist or nurse, has been first-line therapy for walking impairment in people disabled by lower extremity peripheral artery disease (PAD). In a metaanalysis of 25 randomized clinical trials (RCTs) that included 1054 participants with PAD, supervised walking exercise therapy was associated with an improvement in maximal treadmill walking distance of 180 m (95% CI, 130 m to 230 m) when compared with a control group that did not exercise.1 Currently, clinical practice guidelines from different countries and medical specialties unequivocally endorse supervised exercise as first-line therapy for PAD.

大约30年来，监督下的运动疗法，通常包括在卫生保健机构由运动生理学家或护士在场的情况下在跑步机上行走运动，一直是治疗下肢周围动脉疾病（PAD）致残者行走障碍的一线疗法。在25项随机临床试验（RCTs）的meta分析中，包括1054名PAD参与者，与不运动的对照组相比，监督下的步行运动疗法与最大跑步机步行距离的改善有关，达到180米（95%CI，130米至230米）。

Based on the benefits of supervised walking exercise for PAD, in 2017 the Centers for Medicare & Medicaid Services (CMS) began providing insurance coverage for supervised exercise therapy for patients with PAD. However, most people with PAD do not participate in supervised exercise.2,3 Among 129 699 people in the CMS Institutional Outpatient File between June 1, 2017, and December 31, 2018, with a diagnosis of symptomatic PAD (intermittent claudication), only 1735 (1.3%) were enrolled in supervised exercise therapy.2 Even among those enrolled in supervised exercise, only 89 (5.1%) completed all 36 sessions.2Reasons for low participation rates include the inconvenience of regular travel to a facility for supervised exercise and a lack of exercise facilities that provide supervised exercise therapy for PAD.3,4 Home-based walking exercise, defined by walking exercise conducted in or near the home without the presence of an exercise physiologist or nurse, circumvents the requirements for a facility and the inconvenience of traveling to a center for exercise and could increase participation in exercise activity by patients with PAD.

基于监督下的步行运动对PAD的益处，2017年，美国医疗保险和医疗补助服务中心（CMS）开始为PAD患者提供监督下的运动疗法的保险覆盖。然而，大多数PAD患者并没有参加监督下的运动。在2017年6月1日至2018年12月31日期间，CMS机构门诊档案中的129,699人，诊断为有症状的PAD（间歇性跛行），只有1,735人（1.3%）参加了监督下的运动治疗。参与率低的原因包括：定期前往设施进行监督运动的不便，以及缺乏为PAD提供监督运动治疗的设施。基于家庭的步行运动，是指在家中或附近进行的步行，没有运动生理学家或护士在场，规避了对设施的要求和前往运动中心的不便，可以增加PAD患者对运动活动的参与。

However, enthusiasm and evidence for home-based walking exercise for patients with PAD has been modest. In the 1990s, several clinical trials with sample sizes of approximately 20 people with PAD showed no benefits of homebased exercise when patients with PAD were simply given advice to go home and walk. Consequently, clinical practice guidelines in 2005 asserted that there was no evidence to advise people with PAD to walk for exercise at home.5 Since 2011, at least 7 RCTs of home-based exercise with sample sizes of more than 100 people with PAD have been published.4 Results of these trials were mixed, with some showing no benefit of home-based exercise on walking impairment in PAD and others demonstrating large gains of as much as a 41- to 53-m improvement in 6-minute walk distance compared with a nonexercise control group.4,6 In comparison, the most effective supervised treadmill exercise programs have typically demonstrated gains of 15 to 33 m in 6-minute walk distance, compared with nonexercise control groups in people with PAD.4 The inconsistency of results from RCTs of home-based walking exercise has contributed to uncertainty regarding the benefits of home-based exercise for PAD.

然而，对PAD患者进行家庭步行运动的热情和证据都不高。20世纪90年代，几项样本量约为20人的PAD临床试验显示，当PAD患者只是被建议回家步行时，家庭运动并无益处。因此，2005年的临床实践指南断言，没有证据表明可以建议PAD患者在家步行运动。这些试验的结果不一，有些表明在家运动对PAD患者的步行障碍没有好处，有些则表明与不运动的对照组相比，6分钟步行距离有41-53米的大幅提高。相比之下，最有效的有监督的跑步机运动项目通常表明，与不运动的对照组相比，PAD患者6分钟步行距离增加15到33米。

In this issue of JAMA, Bearne et al7 report results of a multicenter RCT evaluating the effects of a home-based walking exercise behavior change intervention delivered by physical therapists, compared with usual care, on 6-minute walk distance at 3-month follow-up in 190 people with PAD. The 12-week intervention consisted of two 60-minute individual in-person sessions in weeks 1 and 2 of the intervention and two 20-minute telephone calls in weeks 6 and 12 of the intervention. These 4 intervention sessions were delivered by physical therapists who used motivational interviewing, guided by behavior-change principles, to help participants set individualized walking exercise goals,monitor their progress, and identify and overcome challenges to walking exercise adherence. At 3-month follow-up, 6-minute walk distance changed from 352.9 m at baseline to 380.6 m in the intervention group and from 369.8m to 372.1m in the usual care group (adjusted mean between-group difference, 16.7 m [95% CI, 4.2 m to 29.2 m]; P = .009). This effect of the intervention was consistent with a statistically significant and modest but clinically meaningful improvement in 6-minute walk distance.7 In contrast with the RCTs that demonstrated larger effects of home-based walking exercise for people with PAD, the trial by Bearne et al7 included fewer in-person visits and did not objectively monitor intensity of walking exercise, which may have lessened the potency of the home-based exercise intervention.6-8

在本期的JAMA上，Bearne等人报告了一项多中心RCT的结果，评估了由理疗师提供的基于家庭的步行运动行为改变干预的效果，与常规护理相比，190名PAD患者在3个月的随访中6分钟步行距离。为期12周的干预措施包括在干预的第1和第2周进行两次60分钟的单独面谈，在干预的第6和第12周进行两次20分钟的电话沟通。这4次干预会议是由理疗师提供的，他们在行为改变原则的指导下，使用激励性访谈，帮助参与者设定个性化的步行运动目标，监测他们的进展，并识别和克服步行运动坚持的挑战。在3个月的随访中，干预组的6分钟步行距离从基线的352.9米变为380.6米，常规护理组从369.8米变为372.1米（调整后的组间平均差异为16.7米[95%CI，4.2米至29.2米]；P=0.009）。干预的这一效果与6分钟步行距离的统计学意义和适度但有临床意义的改善是一致的。与证明基于家庭的步行运动对PAD患者有较大影响的RCTs相比，Bearne等人的试验包括较少的亲自访问，并且没有客观地监测步行运动的强度，这可能降低了基于家庭运动的干预效果。

RCTs of home-based exercise interventions for patients with PAD have been heterogeneous, differing with regard to frequency and type of study coach interactions, extent of incorporation of behavioral-change methods, and the presence and type of devices, such as pedometers or other activity devices, used to monitor walking exercise activity. Home-based exercise interventions that engaged participants in monitoring their own exercise activity and included more frequent coach contact and feedback were more effective.4,6,8 Recently, the LITE (Low-Intensity Exercise Intervention in PAD) multicentered RCT demonstrated that helping patients to walk for exercise at home at a pace that induced maximal leg symptoms was also important for improving walking impairment in people with PAD.6 Of 305 participants with PAD in the LITE Trial randomized to either home-based walking exercise at a pace inducing maximal ischemic leg symptoms, home-based walking exercise at a comfortable pace without ischemic leg symptoms, or a control group that did not exercise, those randomized to home-based walking exercise at a pace inducing maximal ischemic leg symptoms significantly improved 6-minute walk distance, compared with the group randomized to home-based exercise at a comfortable pace without ischemic leg symptoms (49.6 m [95% CI, 24.3 m to 74.9 m]). Those randomized to home-based exercise at a comfortable pace without ischemic leg symptoms did not significantly improve 6-minutewalk distance more than individuals in the control group (8.7 m [95% CI, −17.0 m to 34.4 m]). The highly heterogeneous nature of home-based exercise interventions has likely contributed to the inconsistency of results of RCTs testing home-based exercise interventions for people with PAD.

针对PAD患者的家庭运动干预的RCT是不同的，在研究中教练互动的频率和类型、行为改变方法的结合程度、以及用于监测步行运动的设备（如计步器或其他活动设备）的存在和类型等方面都有所不同。最近，LITE（PAD中的低强度运动干预）多中心RCT证明，帮助患者在家中以引起最大腿部症状的速度行走运动，对改善PAD患者的行走障碍也很重要。在LITE试验中，305名PAD患者被随机分配到以诱发最大缺血性腿部症状的速度进行家庭步行运动、以无缺血性腿部症状的舒适速度进行家庭步行运动或不运动的对照组中，与随机分配到以无缺血性腿部症状的舒适速度进行家庭步行运动的组相比，随机分配到以诱发最大缺血性腿部症状的速度进行家庭步行运动的组明显改善6分钟步行距离（49.6米[95%CI，24.3米至74.9米]）。在没有缺血性腿部症状的情况下，那些被随机分配到以舒适步伐进行家庭运动的人并没有比对照组的人更明显地改善6分钟步行距离（8.7米[95%CI，-17.0米至34.4米]）。基于家庭的运动干预具有高度的异质性，这可能是导致对PAD患者进行家庭运动干预的RCT结果不一致的原因。

In contrast, supervised treadmill exercise interventions for PAD have been consistent, typically composed of treadmill walking exercise conducted at a facility 3 days per week, in the presence of an exercise physiologist or nurse, lasting at least 12 weeks, and building to 30 to 50 minutes of exercise per session by the end of the intervention. The homogeneity of the typical supervised treadmill exercise intervention has likely contributed to the consistency of observed benefits of supervised treadmill exercise for PAD.1,4 The use of maximal treadmill walking distance as the primary outcome for most RCTs of supervised exercise has also likely accentuated the benefits of supervised treadmill exercise for PAD, due to a “training to the outcome measure” effect.9

相比之下，针对PAD的有监督的跑步机运动干预是一致的，通常由每周3天的跑步机行走运动组成，有运动生理学家或护士在场，持续至少12周，并在干预结束时达到每次30至50分钟的运动。典型的指导下的跑步机运动干预的同质性可能有助于观察到指导下的跑步机运动对PAD的益处的一致性。在大多数指导下的运动的RCT中，使用最大的跑步机行走距离作为主要结果，这也可能突出了指导下的跑步机运动对PAD的益处，这是由于“训练结果测量”效应。

Over the past 10 years, results from RCTs have identified components of home-based exercise interventions that were associated with higher potency of the intervention for people with PAD. However, no definitive multicenter RCTs have directly compared supervised treadmill exercise to a potent home-based exercise intervention that includes behavioralchange principles, monitoring to help patients adhere to exercise at a pace inducing ischemic leg symptoms, and other characteristics of highly effective home-based exercise interventions for PAD. A highly effective home-based exercise program has the potential to help millions of people with PAD, including those in rural areas without access to supervised exercise therapy and those unable to travel regularly to the facility to participate. By avoiding the need for an exercise facility or a coach during each exercise session, home-based exercise programs are likely to be less costly than supervised exercise. Given the absence of alternative highly effective noninvasive therapies for PAD, developing home-based exercise into first-line therapy for PAD is an imperative.

在过去的10年中，RCTs的结果已经确定了基于家庭的运动干预的组成部分，这些组成部分与PAD患者的干预效力较高有关。然而，还没有明确的多中心RCT研究直接比较有监督的跑步机运动和有效的家庭运动干预，包括行为改变原则、监测以帮助患者坚持以诱发腿部缺血症状的速度运动，以及其他高效的家庭运动干预PAD的特点。一个高效的基于家庭的运动项目有可能帮助数百万PAD患者，包括那些在农村地区无法获得监督下的运动治疗和那些无法定期前往设施参与的患者。由于避免了每次运动时对运动设施或教练的需求，基于家庭的运动项目可能比监督下的运动成本更低。鉴于缺乏替代性的高效非侵入性疗法，将家庭运动发展为PAD的一线疗法势在必行。

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