NCT07143539

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism (VTE)
• Exercise Therapy
• Quality of Life (QOL)
• Anxiety Depression
• Humans
• Exercise Tolerance
• Rehabilitation Exercise
• Dyspnea
• Functional Status
• Pulmonary Embolism (Diagnosis)

Interventions

Type	Name	Description
OTHER	Exercise-based rehabilitation program	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.

Timeline

• Start date: 2025-12-19
• Primary completion: 2028-03-01
• Completion: 2028-06-01
• First posted: 2025-08-27
• Last updated: 2026-03-02

Locations

5 sites across 1 country: Switzerland