McGregor Gordon, Evans Becky, Sandhu Harbinder, Simmonds Jane, Joshi Shivam, Devi Gita, Zhupaj Albiona, Holliday Nikki, Pearce Gemma, Patel Chloe, Hee Siew Wan, Powell Richard, Heine Peter, Patel Shilpa, Kavi Lesley, Bruce Julie, Hayat Sajad, Lim Boon, Eftekhari Helen, Panikker Sandeep
Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, CV1 3LN, UK.
Centre for Sport, Exercise and Life Sciences, Research Institute for Health &Wellbeing, Coventry University, Coventry, UK.
Pilot Feasibility Stud. 2022 May 7;8(1):101. doi: 10.1186/s40814-022-01056-6.
The PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with Postural Tachycardia Syndrome (PoTS). The original trial protocol was published in BMC Pilot & Feasibility Studies (accessible at https://doi.org/10.1186/s40814-020-00702-1 ). The PULSE intervention consists of (1) individual assessment; (2) 12-week, twice-weekly, supervised exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention is best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. Sixty-two people (aged 18-60 years) with a confirmed diagnosis of PoTS will be invited to enrol on a feasibility RCT with an embedded qualitative study. The primary outcome will be feasibility; process-related measures will include eligibility, recruitment, randomisation and withdrawal rates, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes will be assessed. In response to the COVID-19 pandemic, here we describe amendments to the trial protocol.
Restrictions imposed by the COVID-19 pandemic meant it was necessary to change the delivery of the PULSE and control interventions. These changes reflected the need to limit the risk of COVID-19 transmission in a clinical population, some of whom were at increased risk of contracting the virus and suffering serious illness. The major change was that the originally intended centre-based PULSE and control interventions would now be delivered remotely on-line. Subsequently, there were minor changes to the participant eligibility criteria. These decisions followed an on-line co-creation session with people affected by PoTS, and relevant public and professional stakeholders.
We present an update of the original trial protocol in response to the COVID-19 pandemic. No participants were recruited to the original protocol; thus, results will reflect the on-line delivery of the intervention. PULSE will be the first randomised trial to assess the feasibility of conducting a definitive multi-centre RCT testing supervised on-line exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with PoTS.
ISRCTN45323485 registered on 7 April 2020.
PULSE（体位性心动过速综合征运动后）研究是一项随机对照试验，旨在评估针对体位性心动过速综合征（PoTS）患者开展一项多中心随机对照试验的可行性，该试验将在行为和动机支持下的监督运动康复与最佳实践常规护理进行比较。原始试验方案发表于《BMC试点与可行性研究》（可在https://doi.org/10.1186/s40814-020-00702-1获取）。PULSE干预包括：（1）个体评估；（2）为期12周、每周两次的监督运动训练；（3）行为和动机支持；（4）指导性的生活方式体育活动。对照干预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。62名确诊为PoTS的18至60岁患者将被邀请参加一项包含嵌入式定性研究的可行性随机对照试验。主要结局将是可行性；与过程相关的指标将包括合格性、招募、随机化和退出率，以及运动计划依从性和可接受性指标。还将评估次要的生理、临床和健康相关结局。鉴于2019冠状病毒病疫情，在此我们描述试验方案的修订内容。
2019冠状病毒病疫情带来的限制意味着有必要改变PULSE干预和对照干预的实施方式。这些改变反映了在临床人群中限制2019冠状病毒病传播风险的必要性，其中一些人感染该病毒并患重病的风险增加。主要变化是原本计划在中心进行的PULSE干预和对照干预现在将通过在线远程方式实施。随后，对参与者资格标准进行了细微调整。这些决定是在与受PoTS影响的人群以及相关公众和专业利益相关者进行的在线共创会议之后做出的。
我们针对2019冠状病毒病疫情对原始试验方案进行了更新。原始方案尚未招募任何参与者；因此，结果将反映干预措施的在线实施情况。PULSE将是第一项随机试验，用于评估针对PoTS患者开展一项确定性多中心随机对照试验的可行性，该试验将在行为和动机支持下的在线监督运动康复与最佳实践常规护理进行比较。
ISRCTN45323485，于2020年4月7日注册。
