Outpatient pulmonary rehabilitation for patients after pulmonary embolism

Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study

This study is testing whether a 6-week outpatient rehabilitation program can help people recover better and feel healthier after experiencing a pulmonary embolism.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Medical University of Vienna (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Vienna)
• Trial ID: NCT04615130 on ClinicalTrials.gov

What this trial studies

This multicenter, parallel, randomized waitlist-controlled trial investigates the short-term benefits of outpatient pulmonary rehabilitation (PR) for patients recovering from acute pulmonary embolism. Participants will be randomly assigned to either an intervention group receiving 6 weeks of PR or a control group that will not receive immediate treatment. After the study period, the control group will also have the opportunity to undergo PR. The aim is to assess improvements in functional capacity and quality of life for those affected by post-PE syndrome.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with post-PE syndrome who are between 12 and 36 weeks post-event and do not have chronic thromboembolic disease.

Not a fit: Patients with chronic pulmonary diseases, active cancer, or those who have had a recent myocardial infarction or cardiac surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve recovery and quality of life for patients suffering from post-pulmonary embolism syndrome.

How similar studies have performed: Other studies have shown positive outcomes with pulmonary rehabilitation in similar patient populations, suggesting a promising approach.

Eligibility criteria

Inclusion Criteria:

* Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:

  * Post-PE functional impairment criteria
  * Post-PE Cardiac Impairment criteria
  * Chronic Thromboembolic Disease criteria
* Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE

Exclusion Criteria:

* CTEPH diagnosis
* Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
* Active cancer
* Pregnancy
* Myocardial infarction or cardiac surgery one year prior to inclusion
* Congenital heart disease, congestive heart failure
* History of stroke
* Any previous inpatient or outpatient PR

Additional criteria that are absolute contraindications for pulmonary rehabilitation

* Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders)
* open tuberculosis
* active infectious diseases and acute inflammatory processes
* Stressful and time-consuming therapy that significantly impair the ability to rehabilitate (e.g. chemotherapy or radiation therapy after malignancy)
* Participants who are not sufficiently resilient due to physical or mental impairment and / or cannot be mobilized and therefore cannot actively use the rehabilitation facility
* lack of motivation for therapy
* massive incontinence
* drugs and alcohol addiction

Where this trial is running

Vienna

• Therme Wien Med — Vienna, Austria (RECRUITING)

Study contacts

• Study coordinator: Stephan Nopp, Dr.

Conditions: Pulmonary Embolism, Pulmonary Rehabilitation, Exercise Training