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

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ClinicalTrials.gov Identifier: NCT04615130
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Stephan Nopp, Medical University of Vienna

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pulmonary Embolism Other: Rehabilitation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Patients will undergo 6 weeks of outpatient rehabilitation.
 Other: Rehabilitation
Rehabilitation, exercise training
No Intervention: Control
Patients will receive no intervention throughout the 6 weeks period.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 24 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)
  • 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615130


Contacts
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Contact: Stephan Nopp, Dr. +43 40400 44170 stephan.nopp@meduniwien.ac.at

Locations
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Austria
Therme Wien Med Recruiting
Vienna, Austria
Contact: Stephan Nopp, MD         
Sponsors and Collaborators
Medical University of Vienna
  Study Documents (Full-Text)

Documents provided by Stephan Nopp, Medical University of Vienna:
Study Protocol and Statistical Analysis Plan  [PDF] July 28, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stephan Nopp, Principal investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04615130    
Other Study ID Numbers: 1335/2020
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephan Nopp, Medical University of Vienna:
Pulmonary Rehabilitation
Exercise Training
Pulmonary Embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases