Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.
Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
BMC Pulm Med. 2020 May 19;20(1):143. doi: 10.1186/s12890-020-01182-y.
Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.
This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.
The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.
ISRCTN no. 10608766, prospectively registered on 18th March 2019.
对于肺动脉高压（PH）1 组（肺动脉高压）和 4 组（慢性血栓栓塞性疾病）的患者，监督心肺康复可能是安全且有益的，尤其是作为住院患者。但尚未在最常见的 PH 组（2 组[左心疾病]、3 组[肺部疾病]或 5 组[其他疾病]）中进行测试。此外，尚未在英国国家医疗服务体系（NHS）门诊环境中或在长期随访中进行评估。本随机对照试验（RCT）的目的是测试与最佳实践常规护理相比，监督运动康复干预和心理社会支持对社区/门诊环境中 PH 患者的临床和成本效益。
这项多中心、实用、双臂 RCT 具有嵌入式过程评估，旨在招募 352 名临床稳定的 PH 成人（1-5 组和世界卫生组织功能分类 II-IV）。参与者将被随机分配到监督肺动脉高压运动康复（SPHERe）干预组或对照组。SPHERe 干预包括：1）个人评估和熟悉课程；2）8 周，每周两次，监督门诊运动训练；3）心理社会/动机支持和教育；4）指导家庭运动计划。对照组包括最佳实践常规护理，只有一次一对一的从业者预约，并提供有关体育活动的一般建议。研究人员将对治疗分配保持盲法，在基线、4 个月（干预后）和 12 个月时测量结果。主要结局是 4 个月时的增量穿梭步行测试。次要结局包括健康相关生活质量（HRQoL）、临床恶化时间以及健康和社会保健使用情况。将对参与者（n=20 个干预组和 n=20 个对照组）和从业者（n=20）进行目的抽样访谈，以探讨试验体验、结局和干预措施。
SPHERe 研究是第一项在英国 NHS 评估监督运动康复干预与常规护理相比对所有 PH 组患者的临床和成本效益的多中心临床 RCT。结果将为临床医生和决策者提供信息，了解监督运动康复是否有效，是否应常规为 PH 患者提供。
ISRCTN 编号 10608766，于 2019 年 3 月 18 日前瞻性注册。
