英国两家二级医疗中心针对体位性心动过速综合征患者的运动康复：PULSE可行性随机对照试验
Exercise rehabilitation for people with postural tachycardia syndrome at two secondary care centres in the UK: the PULSE feasibility randomised controlled trial.
作者信息
McGregor Gordon, Evans Becky, Sandhu Harbinder Kaur, Bruce Julie, Devi Gita, Hayat Sajad, Hee Siew Wan, Heine Peter, Holliday Nikki, Joshi Shivam, Kavi Lesley, Boon Lim, Noufaily Angela, Parsons Nicholas, Patel Shilpa, Pearce Gemma, Powell Richard, Schultz Eva, Simmonds Jane, Zhupaj Albiona, Eftekhari Helen, Panikker Sandeep
机构信息
Coventry University, Coventry, UK
University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
出版信息
BMJ Open. 2025 Feb 22;15(2):e090197. doi: 10.1136/bmjopen-2024-090197.
OBJECTIVES
The aim of the study was to assess the feasibility of conducting a definitive multicentre randomised controlled trial (RCT) testing an online exercise rehabilitation and behavioural/motivational support intervention for people with postural tachycardia syndrome (PoTS).
DESIGN
Feasibility RCT.
SETTING
Two secondary care centres.
PARTICIPANTS
Adults aged 18 to 60 years with PoTS. Exclusions were serious mental health/cognitive problem preventing safe participation; currently undertaking physical activity equivalent to the Chief Medical Officer guidelines; pregnancy.
INTERVENTIONS
Participants were randomly assigned (1:1) to best-practice usual care (a single 1:1 session of advice) or the 'postural tachycardia syndrome exercise' (PULSE) intervention: (1) individual online consultation, (2) 12 weeks of supervised online group exercise and behavioural/motivational support, and (3) home exercise programme with recumbent exercise bike.
OUTCOMES
The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate acceptability.
RESULTS
209 patients screened between 5 May 2021 and 1 December 2022, 44 (female 98%; age 29.9 SD, 7.5) were randomised to usual care (n=21) or PULSE (n=23) (71% of target). Follow-up at 4 months was n=12 and n=17 respectively (66% of target). Median live exercise/support session attendance was 15 (IQR 12 to 17) of 18 sessions. Home exercise bike usage was highly variable. There were two serious adverse events in each treatment arm, both unrelated to the trial. Exercise rehabilitation was considered important by participants, and trial procedures, outcomes and interventions were acceptable.
CONCLUSIONS
The PULSE trial procedures and interventions were acceptable, and important design considerations were identified. A definitive RCT testing a remotely supervised exercise rehabilitation and behavioural/motivational support intervention for people with PoTS is feasible in the UK National Health Service.
TRIAL REGISTRATION NUMBER
ISRCTN45323485.
目的
本研究旨在评估开展一项确定性多中心随机对照试验（RCT）的可行性，该试验旨在测试针对体位性心动过速综合征（PoTS）患者的在线运动康复及行为/动机支持干预措施。
设计
可行性随机对照试验。
地点
两个二级医疗中心。
参与者
年龄在18至60岁之间的PoTS成年患者。排除标准为存在严重心理健康/认知问题而无法安全参与；目前所进行的体育活动符合首席医疗官指南；怀孕。
干预措施
参与者被随机分配（1:1）至最佳实践常规护理组（一次一对一的建议咨询）或“体位性心动过速综合征运动”（PULSE）干预组：（1）个人在线咨询，（2）为期12周的在线小组运动及行为/动机支持监督，以及（3）配备卧式健身自行车的家庭锻炼计划。
结果
主要结果为可行性：（1）患者筛查、符合条件、招募、随机分组、退出情况；（2）依从性；（3）生理、临床及患者报告的结果（4个月和7个月时）；以及（4）用于评估可接受性的嵌入式定性研究。
结果
在2021年5月5日至2022年12月1日期间筛查了209名患者，44名（女性占98%；年龄29.9±标准差7.5）被随机分配至常规护理组（n = 21）或PULSE组（n = 23）（达到目标的71%）。4个月时的随访分别为n = 12和n = 17（达到目标的66%）。现场运动/支持课程的出席中位数为18节中的15节（四分位距12至17节）。家庭健身自行车的使用情况差异很大。每个治疗组都有两起严重不良事件，均与试验无关。参与者认为运动康复很重要，试验程序、结果和干预措施均可接受。
结论
PULSE试验的程序和干预措施是可接受的，并确定了重要的设计考量因素。在英国国家医疗服务体系中，开展一项针对PoTS患者的远程监督运动康复及行为/动机支持干预的确定性随机对照试验是可行的。
试验注册号
ISRCTN45323485
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