Safety and effectiveness of the Walk 'n Watch structured, progressive exercise protocol delivered by physical therapists for inpatient stroke rehabilitation in Canada: a phase 3, multisite, pragmatic, stepped-wedge, cluster-randomised controlled trial.

We undertook an implementation trial to enable entire stroke units to use the Walk 'n Watch structured, progressive exercise protocol.

我们进行了一项实施试验，以使整个中风单元能够使用 Walk 'n Watch 结构化、渐进式的运动方案。

Our objective was to evaluate the effectiveness of the Walk 'n Watch implementation package on patient outcomes after 4 weeks in an inpatient stroke rehabilitation setting.

我们的目标是评估Walk 'n Watch实施包在住院卒中康复环境中4周后对患者结果的有效性。

Methods

This pragmatic phase 3, stepped-wedge, cluster-randomised controlled trialtook place in 12 sites (inpatient stroke rehabilitation units) across seven Canadian provinces.

这项实用的第三阶段、分步楔形、群组随机对照试验在加拿大的七个省份的12个地点（住院卒中康复单位）进行。

Each site was randomly allocated (1:1:1:1) to one of four transition sequences with three sites in each sequence.

每个地点被随机分配（1:1:1:1）到四个过渡序列中的一个，每个序列中有三个地点。

Sites changed practice from usual care to Walk 'n Watch at different times according to their allocation.

根据分配，各站点在不同时间从常规护理转变为步行观察。

All front-line physical therapists were trained to deliver the Walk 'n Watch protocol.

所有前线物理治疗师都接受了 Walk 'n Watch 协议的培训。

Walk 'n Watch required completion of a minimum of 30 min of walking-related activities per session, which progressively increased in intensity based on heart rate and step count monitors.

Walk 'n Watch 要求每次会话至少完成30分钟的与行走相关的活动，根据心率和步数监测器的读数，活动强度逐渐增加。

Progressions were prescribed on the basis of a screening 6-minute walk test (6MWT) done by the front-line physical therapist as part of the protocol.

进展是基于前线物理治疗师作为协议一部分进行的筛查6分钟步行测试（6MWT）来规定的。

The primary endpoint was walking endurance (6MWT) at 4 weeks after randomisation.

主要终点是在随机分配后4周的行走耐力（6MWT）。

Masked assessors completed evaluations at baseline and 4 weeks later.

评估者在基线时和4周后完成了评估。

The primary analysis used a linear mixed-effects model adjusted for unit size, stratum, calendar time, age, sex, and baseline 6MWT.

主要分析使用了线性混合效应模型，对单位大小、层次、日历时间、年龄、性别和基线6分钟步行试验（6MWT）进行了调整。

This trial is registered with ClinicalTrials.gov, NCT04238260, and is complete.

该试验已在ClinicalTrials.gov注册，注册号为NCT04238260，并已完成。

Results

Between June 4, 2021, and March 1, 2024, we enrolled 12 sites with 314 participants, of whom eight were deemed ineligible after enrolment and 306 were included in the primary analysis (162 in the usual care group, 144 in the Walk 'n Watch group).

在2021年6月4日至2024年3月1日期间，我们在12个地点招募了314名参与者，其中8人在招募后被认为不符合条件，306人被纳入主要分析（常规护理组162人，步行观察组144人）。

Participants had a mean age of 68 years (SD 13), a mean time since stroke of 29 days (17), and a baseline 6MWT of 152 m (106). 188 (61%) were male and 118 (39%) were female.

参与者平均年龄为68岁（标准差13），中风后平均时间为29天（17天），基线6分钟步行测试（6MWT）为152米（106米）。188人（61%）为男性，118人（39%）为女性。

The mean 6MWT in the usual care group was 137·1 m (100·9) at baseline and 223·6 m (130·4) after 4 weeks.

在常规护理组中，基线时的平均6分钟步行测试（6MWT）为137.1米（100.9米），4周后为223.6米（130.4米）。

The mean 6MWT in the Walk 'n Watch group was 163·6 m (112·7) at baseline and 297·2 m (133·2) after 4 weeks.

Walk 'n Watch组在基线时的平均6分钟步行测试（6MWT）为163.6米（标准差112.7），4周后为297.2米（标准差133.2）。

The 6MWT improvement was 43·6 m (95% CI 12·7-76·1) greater in the Walk 'n Watch group than in the usual care group.

Walk 'n Watch组的6分钟步行测试（6MWT）改善量比常规护理组高出43.6米（95%置信区间12.7-76.1）。

No serious adverse events occurred during a Walk 'n Watch session.

在Walk 'n Watch活动期间没有发生严重不良事件。

Nine serious adverse events were reported and required admission to acute care (four were recorded in the usual care group and five in the Walk 'n Watch group).

报告了九起严重不良事件，需要接受急性护理住院治疗（其中四起记录在常规护理组，五起记录在Walk 'n Watch组）。

interpretation

The Walk 'n Watch protocol resulted in a clinically meaningful improvement in walking endurance in patients with subacute stroke in a real-world setting.

Walk 'n Watch 协议在现实环境中对亚急性期中风患者的步行耐力产生了临床上有意义的改善。

The protocol can be readily implemented into practice with minimal additional resources.

该协议可以轻松地在实践中实施，且仅需最少的额外资源。

Further research is needed to identify characteristics of patients who might benefit the most from Walk 'n Watch.

需要进一步研究以确定哪些患者最有可能从Walk 'n Watch中受益。

funding

Canadian Institutes of Health Research, Canada Brain Research Fund, Michael Smith Health Research BC, Fonds de recherche du Québec-Santé, Canada Research Program, and Heart and Stroke Foundation of Canada.

加拿大卫生研究院、加拿大脑研究基金、迈克尔·史密斯健康研究BC、魁北克健康研究基金会、加拿大研究计划以及加拿大心脏和中风基金会。