Early Exercise-based Rehabilitation in High-risk Patients Hospitalized for Acute Pulmonary Embolism: a Pragmatic Multicenter Randomized Partially Blinded Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Change in generic health-related quality of life (Physical Component Summary score; SF-36)
研究概览
简要总结
Up to half of patients with pulmonary embolism (PE) suffer from impaired quality of life, reduced physical capacity, and symptoms like shortness of breath even three months after diagnosis, despite standard treatment with anticoagulation (blood thinners). The randomized RehabPE trial investigates whether an early, structured rehabilitation program with physical training and patient education can prevent such long-term effects.
The study includes hospitalized patients with acute symptomatic PE who are at increased risk of impaired quality of life three months after diagnosis. After informed consent, patients are randomly assigned to one of two groups: one receives an early 6-8-week, center-based rehabilitation program; the other receives standard follow-up care without rehabilitation. The intervention group completes 16-18 outpatient sessions of endurance and strength training, along with two education sessions covering the condition, treatment, and symptom management.
Over 180 days, changes in quality of life, physical exercise capacity, breathlessness, and psychological symptoms, and the time to return to work / usual daily activities will be monitored and compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study staff, blinded to participants' study group allocation, will conduct follow-up visit and assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Hospitalization for objectively confirmed acute symptomatic PE, defined as intraluminal filling defect of a segmental or more proximal pulmonary artery on computed tomography pulmonary angiography (CTPA) or a high-probability ventilation-perfusion scintigraphy, and admission within the past 7 days
- •Increased risk for post-PE syndrome, defined as simplified Pulmonary Embolism Severity Index (sPESI) ≥1 point at the time of admission
- •Written informed consent
排除标准
- •Contraindication to EBR (known unstable cardiac conditions like angina pectoris, severe valvular heart disease, or severe resting pulmonary hypertension)
- •Medical condition that clearly precludes participation in EBR (e.g., inability to walk, unstable joints, severe neurological impairment)
- •Recently completed (i.e., <6 months), ongoing, or planned in- or outpatient EBR, or planned supervised outpatient physiotherapy for any indication
- •Planned hospitalization during follow-up (e.g., elective surgery or inpatient chemotherapy)
- •Contraindication to anticoagulation
- •Life expectancy <1 year based on the treating physician's clinical judgement
- •Known pregnancy
- •Inability to speak German or French
- •Participation in another study that prohibits concurrent participation in RehabPE
- •Unable to provide informed consent (e.g., due to dementia)
- •Unwilling to provide informed consent
- •Prior enrollment in this study
研究组 & 干预措施
usual care (no rehabilitation)
Participants in the control group will receive usual care (i.e., no exercise-based rehabilitation program)
Early exercise-based rehabilitation (EBR)
Early 6- to 8-week, center-based EBR program, and 2 educational sessions
干预措施: Exercise-based rehabilitation program (Other)
结局指标
主要结局
Change in generic health-related quality of life (Physical Component Summary score; SF-36)
时间窗: From baseline to day 90 after randomization
Change from baseline to day 90 after randomization in generic healt-related quality of life (HRQoL) assessed by the PCS score of the self-completed SF-36 questionnaire. The SF-36 consists of 36 questions measuring 8 domains (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health) and assesses generic HRQoL during the previous 30 days. The PCS score is obtained from all 8 domains and ranges from 0 to 100.
次要结局
- Change in generic health-related quality of life (Physical Component Summary score; SF-36)(From baseline to day 180 after randomization)
- Change in generic health-related quality of life (Mental Component Summary score; SF-36)(From baseline to day 90 and to day 180 after randomization)
- Change in PE-specific health-related quality of life (PEmb-QoL)(From baseline to day 90 and to day 180 after randomization)
- Change in physical exercise capacity (6 minute walking test)(From baseline to day 90 and to day 180 after randomization)
- Change in functional status (Post-VTE Functional Status)(From baseline to day 90 and to day 180 after randomization)
- Time to return to work (workers) or usual activities of daily living (non-workers)(For the duration of the study: 180 days)
- Change in symptoms of anxiety (GAD-7)(From baseline to day 90 and to day 180 after randomization)
- Change in symptoms of depression (PHQ-9)(From baseline to day 90 and to day 180 after randomization)
- Change in dyspnea(From baseline to day 90 and to day 180 after randomization)