Department of Physical Medicine and Rehabilitation, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.
Oslo Centre for Biostatistics and Epidemiology, Institute of Basic Medicine, University of Oslo, Oslo University Hospital, Oslo, Norway.
Trials. 2021 Jan 6;22(1):22. doi: 10.1186/s13063-020-04940-9.
Recently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name "post pulmonary embolism syndrome" (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea, and HRQoL in PPS patients.
A two-center randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1 h) for 8 weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval, and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise. Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12 weeks, and 36 weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the modified Medical Research Council scale, the Shortness of Breath Questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL). Recruitment of 190 patients is currently ongoing.
Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity, and better HRQoL following PE.
Clinical Trials NCT03405480 . Registered prospectively on September 2017. Protocol version 1 (from original protocol September 2017). The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).
最近，大量患有持续性呼吸困难、体力差和生活质量相关下降（HRQoL）的肺栓塞（PE）患者被归类为“肺栓塞后综合征”（PPS）。这些患者似乎是肺康复的合适人选。本研究旨在探讨肺康复方案是否能改善 PPS 患者的体力、呼吸困难和 HRQoL。
该研究在挪威的Østfold 医院和阿克什胡斯大学医院进行了一项两中心随机对照试验（RCT）。将 PPS 患者以 1:1 的比例随机分为干预组和对照组。干预措施包括由经验丰富的物理治疗师提供的每周两次（每次 1 小时）的监督门诊康复方案，共 8 周。干预措施包括根据现有的肺康复方案（放松、间歇和阻力训练）进行个体化的适应性锻炼，以及包括呼吸和循环系统正常解剖和生理学、PE/PPS 信息、呼吸策略和运动/体力活动益处等主题的教育课程。随机分配到对照组的患者将接受常规护理，而不接受特定的运动指导。干预组和对照组的参与者将根据纳入后 12 周和 36 周的增量穿梭步行测试（主要结局）和耐力穿梭步行测试（运动能力）、Sensewear 活动监测器（日常体力活动）、改良的医学研究理事会量表、呼吸急促问卷（呼吸困难）和 EQ-5D-5L 以及肺栓塞生活质量问卷（HRQoL）进行比较。目前正在招募 190 名患者。
本研究的结果可能为一组未经治疗的 PPS 患者提供有效的治疗方法，从而减轻呼吸困难症状、提高运动能力和改善 PE 后的 HRQoL。
临床试验 NCT03405480。于 2017 年 9 月进行前瞻性注册。版本 1（源自 2017 年 9 月原始方案）。研究方案已按照标准方案项目：临床干预试验建议（SPIRIT）指南进行报告（附加文件 1）。
