PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome (PURE-PE)

Medical University of Vienna

Status: Enrolling

Conditions: Pulmonary Embolism

Treatments: Other: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04615130

1335/2020

Details and patient eligibility

About

This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism.

Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients will undergo 6 weeks of outpatient rehabilitation.

Treatment:

Other: Rehabilitation

Control

No Intervention group

Description:

Patients will receive no intervention throughout the 6 weeks period.