Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07143539

Early Exercise-Based Rehabilitation in High-Risk Patients Hospitalized for Acute Pulmonary Embolism: A Pragmatic Multicenter Randomized Trial

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-27

160

Participants Needed

6

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Many patients hospitalized with acute pulmonary embolism (PE) experience lasting symptoms such as shortness of breath, reduced physical ability, and impaired quality of life even three months after diagnosis despite standard treatment with blood thinners. This trial investigates whether an early, structured rehabilitation program involving physical training and patient education can help prevent these long-term effects in patients at high risk of ongoing issues after PE. Participants are randomly assigned to one of two groups. One group receives a center-based exercise-based rehabilitation (EBR) program starting within four weeks of PE diagnosis, consisting of 16 to 18 supervised endurance and strength training sessions over 6 to 8 weeks, plus two educational sessions about PE and symptom management. The control group receives usual care without rehabilitation. The intervention is tailored by physiotherapists to each participant’s abilities. Participants are monitored over 180 days for changes in quality of life, physical exercise capacity using a 6-minute walk test, breathlessness, anxiety and depression symptoms, functional status, and the time it takes to return to work or usual daily activities. Assessments occur at baseline, 90 days, and 180 days after randomization, with safety and adherence being closely observed throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Hospitalized for acute symptomatic pulmonary embolism confirmed by CT pulmonary angiography or ventilation-perfusion scan
  • Admission to hospital within the past 7 days
  • Increased risk for post-pulmonary embolism syndrome (sPESI score of 1 or higher at admission)
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unstable cardiac conditions such as angina, severe valvular heart disease, or severe resting pulmonary hypertension
  • Medical conditions preventing participation in exercise rehabilitation (e.g., inability to walk, unstable joints, severe neurological impairment)
  • Recent (within 6 months), ongoing, or planned exercise-based rehabilitation or supervised physiotherapy
  • Planned hospitalization during follow-up (elective surgery or chemotherapy)
  • Contraindication to anticoagulation treatment
  • Life expectancy less than 1 year
  • Pregnancy
  • Inability to speak German or French
  • Participation in another study that prohibits concurrent enrollment
  • Unable or unwilling to provide informed consent
  • Previous enrollment in this study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 to 8 weeks

Participants in the intervention group participate in a patient-tailored early exercise-based rehabilitation program comprising 16-18 supervised aerobic and resistance training sessions over 6 to 8 weeks, along with 2 educational sessions. Participants in the control group receive usual care without rehabilitation.

16 to 18 supervised exercise sessions and 2 educational sessions at outpatient centers

Follow-up

Duration - Up to 180 days after randomization

Participants are monitored for changes in health-related quality of life, physical exercise capacity, functional status, symptoms, and return to usual activities for up to 180 days after randomization.

Follow-up assessments at approximately 90 and 180 days after randomization

Trial Site Locations

Total: 6 locations

1

Cantonal Hospital Aarau

Aarau, Switzerland

Actively Recruiting

2

Cantonal Hospital Baden

Baden, Switzerland

Actively Recruiting

3

Inselspital, Bern University Hospital

Bern, Switzerland, 3010

Actively Recruiting

4

Geneva University Hospitals

Geneva, Switzerland

Actively Recruiting

5

Lausanne University Hospital

Lausanne, Switzerland

Actively Recruiting

6

University Hospital Zürich

Zurich, Switzerland

Actively Recruiting

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Research Team

T

Tobias Tritschler, Prof. Dr. med., MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Effects of pulmonary rehabilitation on cardiac magnetic resonance parameters in patients with persistent dyspnea following pulmonary embolism.

J Gleditsch, Ø Jervan, S Haukeland-Parker...

https://pubmed.ncbi.nlm.nih.gov/35345773

Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial.

Nanna Rolving, Barbara C Brocki, Jannie R Bloch-Nielsen...

https://pubmed.ncbi.nlm.nih.gov/32108888