Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Vita stråket 13, Gothenburg SE-413 45, Sweden.
Department of Molecular and Clinical Medicine, Sahlgrenska Academy, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.
Eur J Cardiovasc Nurs. 2023 May 25;22(4):400-411. doi: 10.1093/eurjcn/zvac070.
Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise programmes (SEPs) are underutilized, while home-based structured exercise programmes (HSEPs) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. The aim of the study was to compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC.
This three-armed, multicentre randomized clinical trial enrolled patients with IC; all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs. HSEP regarding the 6-min walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the walking impairment questionnaire. Outcomes were assessed at baseline, 3, 6, and 12 months by a blinded evaluator. Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP and SEP, 24 and 26% patients, respectively, were fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0 to 12 months was -11.6 m, 95% confidence interval: -36.4 to 13.0 m (i.e. within the pre-specified non-inferiority margin).
The HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at 1 year.
ClinicialTrials.gov: NCT02341716.
在间歇性跛行（IC）中，监督下的运动是一种被指南推荐的治疗方法。基于医院的监督运动方案（SEPs）的利用率较低，而基于家庭的结构化运动方案（HSEPs）则引起了关注。HSEP 在 IC 中的结果不一致，可能不会带来益处，并且可能不如 SEP 有效。本研究的目的是比较最佳药物治疗（包括单独使用北欧杖步行咨询（WA），或 WA+SEP 或 WA+HSEP）对 IC 患者的疗效。
这项三臂、多中心随机临床试验纳入了 IC 患者；所有患者均接受了最佳药物治疗，包括步行杖和定期北欧杖步行（WA）的建议。对于 HSEP 和 SEP，提供了额外的运动方案。主要研究假设是 SEP 与 HSEP 在 6 分钟步行测试（6MWT）最大距离方面的非劣效性分析，设定了 50m 的非劣效性边界。支持性结果包括肌肉耐力测试和步行障碍问卷。由盲法评估员在基线、3、6 和 12 个月时进行评估。共纳入 166 名患者（平均年龄 72 岁，59%为男性）进行随机分组。在 HSEP 和 SEP 中，分别有 24%和 26%的患者完全坚持运动。所有三组在随访期间均改善了无痛步行距离，但组间无显著差异。从 0 到 12 个月，SEP 和 HSEP 组间的 6MWT 差值为-11.6m，95%置信区间为-36.4 至 13.0m（即在预设的非劣效性边界内）。
HSEP 在 IC 患者中与 SEP 相比非劣效。在 1 年时，三组之间没有观察到显著差异。
ClinicalTrials.gov：NCT02341716。
