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评估姿势性直立性心动过速综合征(POTS)患者在进行为期16周的结构化运动计划后的症状改善情况:一项临床门诊环境下随机交叉试验的方案。

Assessing symptom improvement in patients with postural orthostatic tachycardia syndrome (POTS) following a 16-week structured exercise programme: a protocol for a randomised cross-over trial in a clinical outpatient setting.

作者信息

Kharraziha Isabella, Zulj Rafael, Holm Hannes, Fedorowski Artur, Hamrefors Viktor

机构信息

Department of Cardiology, Skåne University Hospital, Malmo, Sweden

Department of Clinical Sciences, Lund University, Malmö, Sweden.

出版信息

BMJ Open. 2025 Jun 30;15(6):e097057. doi: 10.1136/bmjopen-2024-097057.

Abstract

INTRODUCTION

Exercise training is recommended as a complementary treatment in postural orthostatic tachycardia syndrome (POTS) according to international guidelines. However, less is known regarding how exercise training could successfully be implemented in clinical practice in patients with POTS. Thus, in the current study, we aim to assess the effect of a 16-week tailored exercise training programme in POTS.

METHODS AND ANALYSIS

A total of 200 patients diagnosed with POTS will be recruited. The study will be conducted as a randomised cross-over study. POTS symptoms will be evaluated using the Malmö POTS Symptom Score, Orthostatic Hypotension Questionnaire and 36-item Short Form Health Survey. Haemodynamic parameters will be evaluated by orthostatic tests and maximum working capacity evaluated by bicycle exercise test. Symptoms, haemodynamic parameters and exercise capacity will be assessed before and after a 16-week training programme.

ETHICS AND DISSEMINATION

The study was approved by the Swedish ethical review authority (2022-03186-01) and all procedures will be performed in accordance with the Helsinki Declaration. Results will be made available to patients with POTS, healthcare professionals, the funders and other researchers in publicly available (open access) medical journals.

TRIAL REGISTRATION DETAILS

NCT05554107, registered on 26 September 2022.

摘要

引言

根据国际指南,运动训练被推荐作为体位性直立性心动过速综合征(POTS)的辅助治疗方法。然而,关于如何在POTS患者的临床实践中成功实施运动训练,我们所知甚少。因此,在本研究中,我们旨在评估一项为期16周的针对POTS的量身定制运动训练计划的效果。

方法与分析

总共将招募200名被诊断为POTS的患者。该研究将作为一项随机交叉研究进行。POTS症状将使用马尔默POTS症状评分、直立性低血压问卷和36项简短健康调查进行评估。血流动力学参数将通过直立试验进行评估,最大工作能力将通过自行车运动试验进行评估。在为期16周的训练计划前后,将对症状、血流动力学参数和运动能力进行评估。

伦理与传播

该研究已获得瑞典伦理审查机构(2022-03186-01)的批准,所有程序将按照《赫尔辛基宣言》进行。研究结果将提供给POTS患者、医疗保健专业人员、资助者和其他研究人员,并发表在公开可用(开放获取)的医学期刊上。

试验注册详情

NCT05554107,于2022年9月26日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8bbd/12211820/c988955bc661/bmjopen-15-6-g001.jpg

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