Early Exercise-Based Rehabilitation in Patients Hospitalized for Acute Pulmonary Embolism (RehabPE)

Insel Gruppe AG, University Hospital Bern

Status: Not yet enrolling

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

Treatments: Other: Exercise-based rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT07143539

2025-01502

Details and patient eligibility

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Early exercise-based rehabilitation (EBR)

Active Comparator group

Description:

Early 6- to 8-week, center-based EBR program, and 2 educational sessions

Treatment:

Other: Exercise-based rehabilitation program

usual care (no rehabilitation)

No Intervention group

Description:

Participants in the control group will receive usual care (i.e., no exercise-based rehabilitation program)