NCT07143539 Early Exercise-Based Rehabilitation in Patients Hospitalized for Acute Pulmonary Embolism
| NCT ID | NCT07143539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Venous Thromboembolism (VTE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-12-17 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age ≥18 years 2. 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 3. Increased risk for post-PE syndrome, defined as simplified Pulmonary Embolism Severity Index (sPESI) ≥1 point at the time of admission 4. Written informed consent Exclusion Criteria: 1. Contraindication to EBR (known unstable cardiac conditions like angina pectoris, severe valvular heart disease, or severe resting pulmonary hypertension) 2. Medical condition that clearly precludes participation in EBR (e.g., inability to walk, unstable joints, severe neurological impairment) 3. Recently completed (i.e., \<6 months), ongoing, or planned in- or outpatient EBR, or planned supervised outpatient physiotherapy for any indication 4. Planned hospitalization during follow-up (e.g., elective surgery or inpatient chemotherapy) 5. Contraindication to anticoagulation 6. Life expectancy \<1 year based on the treating physician's clinical judgement 7. Known pregnancy 8. Inability to speak German or French 9. Participation in another study that prohibits concurrent participation in RehabPE 10. Unable to provide informed consent (e.g., due to dementia) 11. Unwilling to provide informed consent 12. Prior enrollment in this study
Contact & Investigator
Tobias Tritschler, Prof. Dr. med., MSc
PRINCIPAL INVESTIGATOR
Inselspital, Universitätsspital Bern
Frequently Asked Questions
Who can join the NCT07143539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism (VTE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07143539 currently recruiting?
Yes, NCT07143539 is actively recruiting participants. Contact the research team at tobias.tritschler@insel.ch for enrollment information.
Where is the NCT07143539 trial being conducted?
This trial is being conducted at Aarau, Switzerland, Baden, Switzerland, Bern, Switzerland, Geneva, Switzerland and 2 additional locations.
Who is sponsoring the NCT07143539 clinical trial?
NCT07143539 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Tobias Tritschler, Prof. Dr. med., MSc at Inselspital, Universitätsspital Bern. The trial plans to enroll 160 participants.