Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease The LITE Randomized Clinical Trial
Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease The LITE Randomized Clinical Trial
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DOI：
10.1001/jama.2021.2536
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发表时间：
2021-04-06
影响因子：
120.7
通讯作者：
Rejeski, W. Jack
中科院分区：
文献类型：
--
作者：
McDermott, Mary M.;Spring, Bonnie;Rejeski, W. Jack
在下肢外周动脉疾病（PAD）患者中，低强度（不引起缺血性腿部症状）家庭步行运动干预是否比高强度（引起缺血性腿部症状）家庭步行运动干预更能改善6分钟步行距离？低强度干预是否比非运动对照组（仅每周健康教育课程）更能改善6分钟步行距离？在这项包括305名PAD患者的多中心随机临床试验中，低强度运动、高强度运动和非运动控制导致6分钟步行距离的平均12个月变化分别为-6.4米、34.5米和-15.1米。低强度运动显著低于高强度运动，与非运动对照组无显著差异。这些发现不支持对PAD患者使用低强度步行运动。这项随机试验比较了舒适的低强度家庭步行运动与足以引起缺血性症状的高强度运动与非运动控制对外周动脉疾病（PAD）患者6分钟步行距离的影响。有监督的高强度步行运动可诱发缺血性腿部症状，是下肢外周动脉疾病（PAD）患者的一线治疗方法，但依从性差。目的探讨低强度舒适的家庭步行运动是否能显著提高PAD患者的步行能力，与高强度家庭步行运动诱导缺血性腿部症状和非运动对照相比。设计、环境和参与者在美国4个中心进行的多中心随机临床试验，包括305名参与者。入组时间为2015年9月25日至2019年12月11日；最后一次随访是在2020年10月7日。PAD患者被随机分为低强度步行组（n = 116）、高强度步行组（n = 124）和非运动组（n = 65），为期12个月。两个锻炼组都被要求在无人监督的环境中散步锻炼，每周5次，每次不超过50分钟，并佩戴加速度计记录锻炼强度和时间。低强度组以无缺血性腿部症状的速度行走。高强度组以引起中度至重度腿部缺血症状的速度行走。教练可以看到加速度计的数据，他每周给参与者打电话，持续12个月，帮助他们坚持规定的锻炼。不运动的对照组在12个月内每周都会接到教育电话。主要结局和测量主要结局是12个月时6分钟步行距离的平均变化（最小临床重要差异为8-20米）。结果305例随机患者（平均年龄69.3 [SD， 9.5]岁，女性146例[47.9%]，黑人181例[59.3%]），250例（82%）完成了12个月的随访。6分钟步行距离从332.1米从基线值的327.5米,12个月随访低强度运动组(类内变化,-6.4 [95% CI, -21.5 - 8.8 m]; P =点)从338.1米到371.2米高强度运动组(类内变化,34.5 [95% CI, 20.1 - 48.9 m]; P <措施)群体间的比较和均值变化是-40.9米(97.5%可信区间,-61.7 - -20.0米;P <措施)。非运动对照组6分钟步行距离从基线时的328.1 m变为12个月随访时的317.5 m（组内平均变化为-15.1 m [95% CI, -35.8 ~ 5.7 m], P = 0.10），与低强度运动组的变化无显著差异（组间平均变化为8.7 m [97.5% CI, -17.0 ~ 34.4 m], P = 0.44）。在184个严重不良事件中，低强度组的事件发生率为0.64，高强度组为0.65，非运动对照组为0.46。每个运动组中有一个严重不良事件与研究参与有关。在PAD患者中，低强度家庭运动明显低于高强度家庭运动，在改善6分钟步行距离方面与非运动对照组无显著差异。这些结果不支持使用低强度的家庭步行运动来改善PAD患者客观测量的步行表现。
Question Does a low-intensity (does not induce ischemic leg symptoms) home-based walking exercise intervention improve 6-minute walk distance more than a high-intensity (induces ischemic leg symptoms) home-based walking exercise intervention and does the low-intensity intervention improve 6-minute walk distance more than a nonexercise control (weekly health educational sessions only) among patients with lower-extremity peripheral artery disease (PAD)? Findings In this multicenter randomized clinical trial that included 305 participants with PAD, low-intensity exercise, high-intensity exercise, and nonexercise control resulted in a mean 12-month change in 6-minute walk distance of -6.4 m, 34.5 m, and -15.1 m, respectively. Low-intensity exercise was significantly less effective than high-intensity exercise and was not significantly different from the nonexercise control. Meaning These findings do not support the use of low-intensity walking exercise for patients with PAD.This randomized trial compares the effects of comfortable low-intensity home-based walking exercise vs high-intensity exercise sufficient to elicit ischemic symptoms vs nonexercise control on 6-minute walk distance among patients with peripheral arterial disease (PAD).Importance Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. Objective To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. Design, Setting, and Participants Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. Interventions Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. Main Outcomes and Measures The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). Results Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, -6.4 m [95% CI, -21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was -40.9 m (97.5% CI, -61.7 to -20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, -15.1 m [95% CI, -35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, -17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation. Conclusions and Relevance Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD.