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腹主动脉瘤患者参加监督性运动训练随机试验的招募情况及体验

Patient recruitment and experiences in a randomised trial of supervised exercise training for individuals with abdominal aortic aneurysm.

作者信息

Gunasekera Roshan C, Moss James, Crank Helen, Mitchell Pauline A, Nawaz Shah, Tew Garry A

机构信息

Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, United Kingdom.

Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom.

出版信息

J Vasc Nurs. 2014 Mar;32(1):4-9. doi: 10.1016/j.jvn.2013.05.002.

Abstract

We sought to describe patient recruitment and experiences in a randomised controlled trial of a 12-week (thrice weekly) supervised exercise program for patients with small abdominal aortic aneurysm (AAA). Potential patients were identified via AAA surveillance lists and vascular clinics and invited to participate in the study. Upon completion of baseline assessments, patients were randomly allocated 1:1 to exercise or usual care. Patients completing the exercise arm were invited to attend a focus group session to explore experiences of diagnosis, management of condition, trial recruitment, and expectations and experiences of the exercise program. Between January 2010 and September 2011, 545 patients were identified. The response rate to postal invitation was 81.7% (445/545), with 108 patients responding as "interested." Only 28 of these patients were eligible and recruited (46.7% of recruitment target), yielding an overall recruitment rate of 5.1%. However, the estimated recruitment rate among eligible patients was 23.7%. Twenty-five patients (89.3%) completed the study, and compliance to the exercise program was 94%. Participants attending the focus group session indicated that the exercise program was manageable, beneficial, and enjoyable. The feasibility of supervised exercise training in individuals with small AAA remains unclear. Our study revealed a poorer than expected recruitment rate, but good compliance to, and feedback for, the exercise intervention. We present potential explanations for these findings and suggestions for future trials involving similar populations.

摘要

我们试图描述一项针对小腹主动脉瘤(AAA)患者的为期12周(每周三次)的监督运动计划的随机对照试验中的患者招募情况及体验。通过AAA监测名单和血管诊所识别潜在患者,并邀请他们参与研究。在完成基线评估后,患者按1:1随机分配至运动组或常规护理组。邀请完成运动组的患者参加焦点小组会议,以探讨诊断体验、病情管理、试验招募以及对运动计划的期望和体验。在2010年1月至2011年9月期间,共识别出545名患者。邮寄邀请的回复率为81.7%(445/545),其中108名患者回复“感兴趣”。这些患者中只有28名符合条件并被招募(占招募目标的46.7%),总体招募率为5.1%。然而,符合条件患者的估计招募率为23.7%。25名患者(89.3%)完成了研究,运动计划的依从率为94%。参加焦点小组会议的参与者表示,运动计划是可行的、有益的且令人愉快的。小AAA患者进行监督运动训练的可行性仍不明确。我们的研究显示招募率低于预期,但运动干预的依从性良好且得到了积极反馈。我们对这些发现提出了潜在解释,并为未来涉及类似人群的试验提供了建议。

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