Early Exercise-Based Rehabilitation in Patients Hospitalized for Acute Pulmonary Embolism
Early Exercise-based Rehabilitation in High-risk Patients Hospitalized for Acute Pulmonary Embolism: a Pragmatic Multicenter Randomized Partially Blinded Superiority Trial
Insel Gruppe AG, University Hospital Bern
160 participants
Dec 19, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria12
- 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
Interventions
Participants in the intervention group will receive a patient-tailored early (i.e., within 4 weeks of PE diagnosis) EBR program, comprising 16-18 sessions of supervised aerobic exercise and resistance/strength training at local outpatient rehabilitation centers, along with 2 PE-related educational sessions at 2 and 6 weeks of rehabilitation. Participants will receive comprehensive information on the purpose of EBR and each of its components, reassurance on its safety, and education on self-monitoring. Furthermore, physiotherapists will tailor the training based on specific capabilities, focusing on areas of weakness.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07143539