Early Exercise-Based Rehabilitation in Patients Hospitalized for Acute Pulmonary Embolism
Recruiting · NCT07143539 · Interventional (participants receive a specific treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
6 locations listed.
- Cantonal Hospital Aarau - Aarau, Switzerland
- Cantonal Hospital Baden - Baden, Switzerland
- Inselspital, Bern University Hospital - Bern, Switzerland
- Geneva University Hospitals - Geneva, Switzerland
- Lausanne University Hospital - Lausanne, Switzerland
- University Hospital Zürich - Zurich, Switzerland