PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

NCT04615130 | Recruiting DMC

• 1 other identifier: 1335/2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary Rehabilitation; Exercise Training; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walk Test

  change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters

  within the 6-week study period

Secondary Outcomes (12)

• peak oxygen consumption

  within the 6-week study period

• Maximal workload

  within the 6-week study period

• One-repetition maximum for lower extremities

  within the 6-week study period

• One-repetition maximum for upper extremities

  within the 6-week study period

• Maximal inspiratory muscle pressure

  within the 6-week study period

Study Arms (2)

Intervention

EXPERIMENTAL

Patients will undergo 6 weeks of outpatient rehabilitation.

Other: Rehabilitation

Control

NO INTERVENTION

Patients will receive no intervention throughout the 6 weeks period.

Interventions

Rehabilitation OTHER

Rehabilitation, exercise training

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Therme Wien Med

Vienna, Austria

RECRUITING

Related Publications (1)

• Fabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789.

  PMID: 34127618 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Stephan Nopp, Dr.

CONTACT

+43 40400 44170; stephan.nopp@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: As the control group will undergo rehabilitation after the study period as well, it is possible to blind patients and outcome assessors to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

AU (1)