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NCT Number: NCT04615130

PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Therme Wien Med

Vienna, Austria

Location status: Recruiting

Location contact

Stephan Nopp, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

Rehabilitation, exercise training

Primary outcomes

  1. 6-Minute Walk Test

    Time frame: within the 6-week study period

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

Secondary outcomes

  1. peak oxygen consumption

    Time frame: within the 6-week study period

    change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry

  2. Maximal workload

    Time frame: within the 6-week study period

    change of maximal workload in cycle ergometer tests measured in Watt

  3. One-repetition maximum for lower extremities

    Time frame: within the 6-week study period

    change of one-repetition maximum for lower extremities measured in kg

  4. One-repetition maximum for upper extremities

    Time frame: within the 6-week study period

    change of one-repetition maximum for upper extremities measured in kg

  5. Maximal inspiratory muscle pressure

    Time frame: within the 6-week study period

    change in maximum inspiratory muscle pressure measured in mbar

  6. Inspiratory muscle endurance

    Time frame: within the 6-week study period

    change in inspiratory muscle endurance measured in seconds

  7. Level of dyspnea

    Time frame: within the 6-week study period

    change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale

  8. Health related quality of life

    Time frame: within the 6-week study period

    change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L)

  9. Disease related quality of life

    Time frame: within the 6-week study period

    change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL)

  10. Functional limitations

    Time frame: within the 6-week study period

    change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form

  11. Functional status

    Time frame: within the 6-week study period

    change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status)

  12. Anxiety and depression

    Time frame: within the 6-week study period

    change in anxiety and depression measured with the hospital anxiety and depression scale (HADS)

Study contacts

Contact information is provided by the study sponsor or research team.

Stephan Nopp, Dr.

CONTACT

[email protected]

+43 40400 44170

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: PURE-PE

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Nov 4, 2020
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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