RecruitingNot ApplicableNCT07143539

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

160 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an early exercise-based rehabilitation program for people hospitalized with a blood clot in the lungs (pulmonary embolism or PE) can help prevent long-term breathing and exercise problems that sometimes develop after a PE event. **You may be eligible if...** - You are 18 or older - You have been hospitalized with a confirmed acute pulmonary embolism within the past 7 days - Your PE puts you at increased risk for long-term complications based on a standardized score - You are able to provide written consent **You may NOT be eligible if...** - You have unstable heart conditions (angina, severe valve disease, severe pulmonary hypertension) that make exercise unsafe - You cannot walk or have conditions preventing safe exercise - You have recently completed or are currently in another rehabilitation program - You have a planned hospitalization or surgery coming up during the follow-up period - You are pregnant - You cannot speak German or French - You have a life expectancy of less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExercise-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.