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一项用于促进间歇性跛行患者行走的团体教育计划的开发及初步随机对照试验

The development and pilot randomised controlled trial of a group education programme for promoting walking in people with intermittent claudication.

作者信息

Tew Garry A, Humphreys Liam, Crank Helen, Hewitt Catherine, Nawaz Shah, Al-Jundi Wissam, Trender Hazel, Michaels Jonathan, Gorely Trish

机构信息

York Trials Unit, Department of Health Sciences, University of York, UK

Centre for Sport and Exercise Science, Sheffield Hallam University, UK.

出版信息

Vasc Med. 2015 Aug;20(4):348-57. doi: 10.1177/1358863X15577857. Epub 2015 Apr 9.

Abstract

UNLABELLED

The aim of this study was to develop and pilot a group education programme for promoting walking in people with intermittent claudication. Patient focus groups (n=24) and literature reviews were conducted to inform the development of the education programme, which involves a three-hour group-based education workshop and follow-up telephone support. A pilot study was subsequently conducted in which 23 new patients (Rutherford category 1-3) were randomly assigned to usual care (control) or usual care plus the education programme. Outcomes were assessed at baseline and six weeks including daily steps (tri-axial accelerometer), walking capacity (six-minute walk test and Gardner treadmill test), and quality of life (Intermittent Claudication Questionnaire [ICQ]). Exit interviews were conducted to assess the acceptability and usefulness of the programme. Compared with controls, the intervention group had superior walking capacity and quality of life at six weeks. Mean differences in six-minute walk distance, treadmill maximum walking distance and ICQ score were 44.9 m (95% confidence interval [CI], 6.9 to 82.9), 173 m (95% CI, 23 to 322), and -10.6 (95% CI, -18.9 to -2.3), respectively. The daily step count did not differ between groups. The exit interviews indicated that participants valued attending the programme, that it gave them a greater understanding of their condition, and that they had been walking more for exercise since attending. The results suggest that the education programme is feasible, acceptable, and potentially useful for improving walking capacity and quality of life. A fully-powered trial exploring clinical and cost effectiveness is needed.

TRIAL REGISTRATION NUMBER

ISRCTN06733130 (http://www.controlled-trials.com).

摘要

未标注

本研究旨在开发并试行一项团体教育计划,以促进间歇性跛行患者的步行。开展了患者焦点小组(n = 24)及文献综述,为教育计划的制定提供信息,该计划包括一个三小时的团体教育工作坊及后续电话支持。随后进行了一项试点研究,将23名新患者(卢瑟福分类1 - 3级)随机分配至常规护理组(对照组)或常规护理加教育计划组。在基线和六周时评估结果,包括每日步数(三轴加速度计)、步行能力(六分钟步行试验和加德纳跑步机试验)以及生活质量(间歇性跛行问卷[ICQ])。进行了退出访谈,以评估该计划的可接受性和实用性。与对照组相比,干预组在六周时具有更好的步行能力和生活质量。六分钟步行距离、跑步机最大步行距离和ICQ评分的平均差异分别为44.9米(95%置信区间[CI],6.9至82.9)、173米(95%CI,23至322)和 - 10.6(95%CI, - 18.9至 - 2.3)。两组间每日步数无差异。退出访谈表明,参与者重视参加该计划,该计划使他们对自身病情有了更深入的了解,并且自参加以来他们为锻炼而步行得更多。结果表明,该教育计划对于改善步行能力和生活质量是可行的、可接受的且可能有用的。需要进行一项充分有力的试验来探索临床和成本效益。

试验注册号

ISRCTN06733130(http://www.controlled-trials.com)

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