Early exercise-based rehabilitation for adults hospitalized with acute pulmonary embolism

Early Exercise-based Rehabilitation in High-risk Patients Hospitalized for Acute Pulmonary Embolism: a Pragmatic Multicenter Randomized Partially Blinded Superiority Trial

This trial tries an early, supervised exercise and education program for adults hospitalized with acute pulmonary embolism to see if it prevents long-term breathlessness and improves quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (other)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Aarau and 4 other locations)
• Trial ID: NCT07143539 on ClinicalTrials.gov

What this trial studies

The randomized RehabPE trial enrolls adults hospitalized with objectively confirmed acute symptomatic pulmonary embolism who are at increased risk of post‑PE problems (sPESI ≥1) and randomizes them to early center‑based rehabilitation or standard follow‑up. The intervention is a 6–8 week outpatient program with 16–18 sessions of endurance and strength training plus two education sessions on the condition, treatment, and symptom management. The control arm receives usual follow‑up without structured rehabilitation. Outcomes include patient‑reported quality of life, physical capacity, and symptom burden measured over 180 days.

Who should consider this trial

Good fit: Adults (≥18 years) hospitalized with objectively confirmed acute symptomatic PE within the past 7 days who have sPESI ≥1, can walk and participate in outpatient exercise, and can give informed consent are ideal candidates.

Not a fit: Patients with contraindications to exercise‑based rehabilitation (for example unstable cardiac disease, severe resting pulmonary hypertension, or inability to walk), those already in recent or planned supervised rehabilitation, or those at low risk for post‑PE syndrome are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could reduce long‑term breathlessness and fatigue and improve physical capacity and health‑related quality of life after pulmonary embolism.

How similar studies have performed: Exercise‑based rehabilitation has improved symptoms and quality of life in other cardiorespiratory conditions, but randomized evidence specifically for early rehabilitation after acute PE is limited.

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

Where this trial is running

Aarau and 4 other locations

• Cantonal Hospital Aarau — Aarau, Switzerland (RECRUITING)
• Cantonal Hospital Baden — Baden, Switzerland (RECRUITING)
• Inselspital, Bern University Hospital — Bern, Switzerland (RECRUITING)
• Geneva University Hospitals — Geneva, Switzerland (RECRUITING)
• University Hospital Zürich — Zurich, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Tobias Tritschler, MD, MSc — Inselspital, Universitätsspital Bern
• Study coordinator: Tobias Tritschler, MD, MSc

Conditions: Venous Thromboembolism, Exercise Therapy, Quality of Life, Anxiety Depression, Humans, Exercise Tolerance, Rehabilitation Exercise, Dyspnea