McGregor Gordon, Hee Siew Wan, Eftekhari Helen, Holliday Nikki, Pearce Gemma, Sandhu Harbinder, Simmonds Jane, Joshi Shivam, Kavi Lesley, Bruce Julie, Panikker Sandeep, Lim Boon, Hayat Sajad
Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Watch Close, Coventry, CV1 3LN UK.
Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.
Pilot Feasibility Stud. 2020 Oct 19;6:157. doi: 10.1186/s40814-020-00702-1. eCollection 2020.
Postural orthostatic tachycardia syndrome (POTS) is an autonomic nervous system disorder causing an abnormal cardiovascular response to upright posture. It affects around 0.2% of the population, most commonly women aged 13 to 50 years. POTS can be debilitating; prolonged episodes of pre-syncope and fatigue can severely affect activities of daily living and health-related quality of life (HRQoL). Medical treatment is limited and not supported by randomised controlled trial (RCT) evidence. Lifestyle interventions are first-line treatment, including increased fluid and salt intake, compression tights and isometric counter-pressure manoeuvres to prevent fainting. Observational studies and small RCTs suggest exercise training may improve symptoms and HRQoL in POTS, but evidence quality is low.
Sixty-two people (aged 18-40 years) with a confirmed diagnosis of POTS will be invited to enrol on a feasibility RCT with embedded qualitative study. The primary outcome will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes including sub-maximal recumbent bike exercise test, active stand test and HRQoL will be measured at 4 and 7 months post-randomisation by researchers blinded to treatment allocation. The PostUraL tachycardia Syndrome Exercise (PULSE) intervention consists of (1) individual assessment; (2) 12-week, once to twice-weekly, supervised out-patient exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention will be best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. For the embedded qualitative study, participants ( = 10 intervention, = 10 control) will be interviewed at baseline and 4 months post-randomisation to assess acceptability and the feasibility of progressing to a definitive trial.
There is very little high-quality research investigating exercise rehabilitation for people with POTS. The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with POTS.
ISRCTN45323485 registered on 7 April 2020.
体位性直立性心动过速综合征（POTS）是一种自主神经系统疾病，会导致心血管系统对直立姿势产生异常反应。它影响着约0.2%的人口，最常见于13至50岁的女性。POTS可能使人虚弱；长时间的晕厥前期和疲劳会严重影响日常生活活动及与健康相关的生活质量（HRQoL）。药物治疗有限，且缺乏随机对照试验（RCT）证据的支持。生活方式干预是一线治疗方法，包括增加液体和盐分摄入、穿紧身弹力袜以及进行等长反压动作以预防昏厥。观察性研究和小型RCT表明，运动训练可能改善POTS患者的症状和HRQoL，但证据质量较低。
62名确诊为POTS的患者（年龄在18 - 40岁之间）将被邀请参加一项包含定性研究的可行性RCT。主要结局将是可行性；与过程相关的指标将包括符合条件、招募、随机分组和退出的人数，以及运动计划依从性和可接受性的指标。次要的生理、临床和与健康相关的结局，包括次极量卧位自行车运动试验、主动站立试验和HRQoL，将在随机分组后4个月和7个月时由对治疗分配不知情的研究人员进行测量。PULSE干预包括：（1）个体评估；（2）为期12周、每周一至两次的门诊监督运动训练；（3）行为和动机支持；（4）有指导的生活方式体育活动。对照干预将是最佳实践常规护理，包括一次30分钟的一对一医生预约，以及关于安全有效的体育活动的一般建议。对于嵌入式定性研究，参与者（干预组 = 10名，对照组 = 10名）将在基线和随机分组后4个月接受访谈，以评估可接受性以及进行确定性试验的可行性。
针对POTS患者进行运动康复的高质量研究非常少。PULSE研究将是第一项随机试验，旨在评估与最佳实践常规护理相比，对POTS患者进行一项确定性多中心RCT的可行性，该RCT测试在行为和动机支持下的监督运动康复。
于2020年4月7日注册，ISRCTN45323485 。
