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肺动脉高压和家庭(PHAHB)运动干预:一项可行性研究方案。

Pulmonary hypertension and home-based (PHAHB) exercise intervention: protocol for a feasibility study.

机构信息

School of Health and Human Performance, Dublin City University, Dublin, Ireland

Department of Sport & Exercise Science, Waterford Institute of Technology, Waterford, Ireland.

出版信息

BMJ Open. 2021 May 10;11(5):e045460. doi: 10.1136/bmjopen-2020-045460.

Abstract

INTRODUCTION

Novel therapies for pulmonary hypertension (PH) have improved survival and slowed disease progression. However, patients still present with symptoms of exertional dyspnoea and fatigue, which impacts their ability to perform activities of daily living, reduces exercise tolerance and impairs their quality of life (QoL). Exercise training has shown to be safe and effective at enhancing QoL and physical function in PH patients, yet it remains an underused adjunct therapy. Most exercise training for PH patients has been offered through hospital-based programmes. Home-based exercise programmes provide an alternative model that has the potential to increase the availability and accessibility of exercise training as an adjunct therapy in PH. The purpose of this study is to investigate the feasibility, acceptability, utility and safety of a novel remotely supervised home-based PH exercise programme.

METHODS

Single arm intervention with a pre/post comparisons design and a follow-up maintenance phase will be employed. Eligible participants (n=25) will be recruited from the Mater Misericordiae University Hospital PH Unit. Participants will undergo a 10-week home-based exercise programme, with induction training, support materials, telecommunication support and health coaching sessions followed by a 10-week maintenance phase. The primary outcomes are feasibility, acceptability, utility and safety of the intervention. Secondary outcomes will include the impact of the intervention on exercise capacity, physical activity, strength, health-related QoL and exercise self-efficacy.

ETHICS AND DISSEMINATION

Ethics approval has been obtained from the Mater Misericordiae Institutional Review Board REF:1/378/2032 and Dublin City University Research Ethics DCUREC/2018/246. A manuscript of the results will be submitted to a peer-reviewed journal and results will be presented at conferences, community and consumer forums and hospital research conferences.

TRIAL REGISTRATION NUMBER

ISRCTN83783446; Pre-results.

摘要

简介

新型肺动脉高压(PH)治疗方法提高了生存率并减缓了疾病进展。然而,患者仍会出现运动性呼吸困难和疲劳症状,这会影响他们进行日常活动的能力,降低运动耐量并损害他们的生活质量(QoL)。运动训练已被证明可安全有效地提高 PH 患者的 QoL 和身体功能,但它仍然是一种未充分利用的辅助治疗方法。大多数 PH 患者的运动训练都是通过医院为基础的方案提供的。家庭为基础的运动方案提供了一种替代模式,有可能增加运动训练作为 PH 辅助治疗的可用性和可及性。本研究的目的是调查一种新型远程监督家庭 PH 运动方案的可行性、可接受性、实用性和安全性。

方法

采用单臂干预、前后比较设计和随访维持阶段。将从 Mater Misericordiae 大学医院 PH 病房招募符合条件的参与者(n=25)。参与者将接受为期 10 周的家庭运动方案,包括入职培训、支持材料、远程通信支持和健康教练课程,然后进行为期 10 周的维持阶段。主要结果是干预措施的可行性、可接受性、实用性和安全性。次要结果将包括干预对运动能力、身体活动、力量、健康相关 QoL 和运动自我效能的影响。

伦理与传播

Mater Misericordiae 机构审查委员会已批准该研究(REF:1/378/2032),都柏林城市大学研究伦理委员会也已批准(DCUREC/2018/246)。研究结果将提交给同行评议期刊,并在会议、社区和消费者论坛以及医院研究会议上进行报告。

试验注册号

ISRCTN83783446;预结果。

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