Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
Cardiovascular Rehabilitation, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
BMJ Open. 2023 Aug 3;13(8):e066053. doi: 10.1136/bmjopen-2022-066053.
People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for people with PH.
Development was completed in three phases: (1) systematic review, (2) stakeholder engagement with consensus from patients and experts and (3) prepilot intervention acceptability testing. We completed systematic reviews to identify international cardiopulmonary rehabilitation guidance and trials of exercise-based interventions for people with PH. Evidence from systematic reviews and stakeholder consensus shaped the SPHERe intervention, including addition of individual behavioural support sessions to promote exercise adherence. The draft SPHERe intervention was ratified through discussions with multidisciplinary professionals and people living with PH. We acceptability tested the centre-based intervention with eight participants in a prepilot development phase which identified a number of condition-specific issues relating to safety and fear avoidance of activity. Comprehensive intervention practitioner training manuals were produced to ensure standardised delivery. Participant workbooks were developed and piloted. Trial recruitment began in January 2020 but was subsequently suspended in March 2020 further to COVID-19 pandemic 'lockdowns'. In response to the pandemic, we undertook further development work to redesign the intervention to be suitable for exclusively home-based online delivery. Recruitment to the revised protocol began in June 2021.
The final SPHERe intervention incorporated weekly home-based online group exercise and behavioural support 'coaching' sessions supervised by trained practitioners, with a personalised home exercise plan and the optional loan of a stationary exercise bike. The intervention was fully manualised with clear pathways for assessment and individualised exercise prescription. The clinical and cost-effectiveness of the SPHERe online rehabilitation intervention is currently being tested in a UK multicentre randomised controlled trial.
ISCRTN10608766.
尽管运动康复有可能减轻呼吸困难和提高生活质量，但患有肺动脉高压（PH）的患者通常并未被转介接受运动康复。我们描述了一种针对 PH 患者的监督肺动脉高压运动康复（SPHERe）计划的开发过程。
开发分为三个阶段完成：（1）系统评价，（2）患者和专家的利益相关者参与并达成共识，（3）预试验干预的可接受性测试。我们完成了系统评价，以确定国际心肺康复指南和针对 PH 患者的基于运动的干预试验。系统评价和利益相关者共识的证据塑造了 SPHERe 干预措施，包括增加单独的行为支持课程以促进锻炼依从性。通过与多学科专业人员和 PH 患者的讨论，对草案 SPHERe 干预措施进行了批准。我们在预试验开发阶段对中心为基础的干预措施进行了可接受性测试，其中确定了与安全性和活动恐惧回避相关的一些特定于疾病的问题。制定了全面的干预措施从业者培训手册，以确保标准化交付。开发并试用了参与者工作手册。试验于 2020 年 1 月开始招募，但随后由于 COVID-19 大流行“封锁”而暂停。为应对大流行，我们进行了进一步的开发工作，以重新设计干预措施，使其适用于完全基于家庭的在线交付。修订后的方案于 2021 年 6 月开始招募。
最终的 SPHERe 干预措施包括每周在家进行在线团体运动和行为支持“辅导”课程，由经过培训的从业者进行监督，提供个性化的家庭运动计划，并可选借用固定自行车。干预措施完全手册化，具有明确的评估和个体化运动处方途径。SPHERe 在线康复干预的临床和成本效益正在英国多中心随机对照试验中进行测试。
ISCRTN10608766。
