Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Department of Health Research and Policy, Stanford University, Stanford, California.
JAMA. 2021 Apr 6;325(13):1266-1276. doi: 10.1001/jama.2021.2536.
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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02538900.
重要性:监督下的高强度步行运动可引起下肢缺血症状,是下肢外周动脉疾病 (PAD) 患者的一线治疗方法,但依从性较差。 目的:确定低强度的家庭步行运动(舒适的速度)与高强度的家庭步行运动(引起下肢缺血症状)和非运动对照组相比,是否能显著改善 PAD 患者的步行能力。 设计、地点和参与者:在美国 4 个中心进行的多中心随机临床试验,共纳入 305 名参与者。招募于 2015 年 9 月 25 日至 2019 年 12 月 11 日进行;最终随访时间为 2020 年 10 月 7 日。 干预措施:将 PAD 患者随机分为低强度步行运动组(n=116)、高强度步行运动组(n=124)和非运动对照组(n=65),进行 12 个月的治疗。两组运动组均被要求在无人监督的环境下每周进行 5 次、每次 50 分钟的步行运动,同时佩戴加速度计记录运动强度和时间。低强度组以不引起下肢缺血症状的速度行走。高强度组以引起中度至重度下肢缺血症状的速度行走。教练可以查看加速度计数据,每周通过电话与参与者联系 12 个月,帮助他们坚持进行规定的运动。非运动对照组在 12 个月内每周接受教育电话。 主要结果和测量:主要结果是 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:在 305 名随机患者中(平均年龄 69.3[标准差 9.5]岁,146 名[47.9%]女性,181 名[59.3%]黑人患者),250 名(82%)完成了 12 个月的随访。低强度运动组的 6 分钟步行距离从基线时的 332.1 米变化到 12 个月时的 327.5 米(组内平均变化为-6.4 米[95%置信区间:-21.5 至 8.8 米];P=0.34),高强度运动组从 338.1 米变化到 371.2 米(组内平均变化为 34.5 米[95%置信区间:20.1 至 48.9 米];P<0.001),组间比较的平均变化为-40.9 米(97.5%置信区间:-61.7 至-20.0 米;P<0.001)。非运动对照组的 6 分钟步行距离从基线时的 328.1 米变化到 12 个月时的 317.5 米(组内平均变化为-15.1 米[95%置信区间:-35.8 至 5.7 米];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 米[97.5%置信区间:-17.0 至 34.4 米];P=0.44)。在 184 例严重不良事件中,低强度组、高强度组和非运动对照组的每位参与者的发生率分别为 0.64、0.65 和 0.46。运动组各有 1 例严重不良事件与研究参与有关。 结论和相关性:在 PAD 患者中,低强度家庭步行运动的效果明显低于高强度家庭步行运动,与非运动对照组相比,改善 6 分钟步行距离的效果也不显著。这些结果不支持使用低强度家庭步行运动来改善 PAD 患者的客观行走能力。 试验注册:ClinicalTrials.gov 标识符:NCT02538900。
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