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    Poster Networking

    Venous Thromboembolism

    Poster Networking Session

    PB0481 - A randomized controlled trial to evaluate the efficacy of an 8-week standardized exercise training program for preventing post-pulmonary embolism syndrome: rationale & design of the PE@HOME study

    Sunday, June 25, 2023
    18:30 – 19:30 ET
    Room: Exhibition

      Presenting Author(s)

    • Dieuwke Luijten, MD, PhD candidate

      Leiden University Medical Center
      Leiden, Zuid-Holland, Netherlands

      • Co-Author(s)

    • AV

      Anton Vonk Noordegraaf

      MD, PhD
      Department of Pulmonology, Amsterdam UMC, VU University Medical Centre
      Amsterdam, Noord-Holland, Netherlands

    • JA

      Jannie J. Abbink

      MD, PhD
      Basalt rehabilitation Center
      Leiden, Zuid-Holland, Netherlands

    • Stefano Barco, MD, PhD, FESC (he/him/his)

      MD, PhD
      Department of Angiology, University Hospital of Zurich
      Zurich, Zurich, Switzerland

    • Jv

      Johanna M.W. van den Berg

      MD
      Department of Pulmonology, Haga Teaching Hospital
      the Hague, Zuid-Holland, Netherlands

    • Jv

      Josien van Es

      MD, PhD
      Department of Pulmonology, Amsterdam UMC, VU University Medical Centre
      Amsterdam, Noord-Holland, Netherlands

    • WG

      Waleed Ghanima

      MD, PhD
      Departments of Oncology, Medicine and Research Ostfold Hospital Trust
      Kalnes, Ostfold, Norway

    • Wv

      Wilbert B. van den Hout

      PhD
      Department of Biomedical Data Sciences - Medical Decision Making, Leiden University Medical Center
      Leiden, Zuid-Holland, Netherlands

    • MH

      Menno V. Huisman

      MD, PhD
      Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands
      Leiden, Zuid-Holland, Netherlands

    • BL

      Bas Langeveld

      MD, PhD
      Department of Pulmonology, Deventer ziekenhuis
      Deventer, Overijssel, Netherlands

    • Iv

      Ivo van der Lee

      MD, PhD
      Department of Pulmonology, Spaarne gasthuis
      Haarlem, Noord-Holland, Netherlands

    • MN

      Maarten K. Ninaber

      MD, PhD
      Department of Pulmonology, Leiden University Medical Center
      Leiden, Zuid-Holland, Netherlands

    • MO

      Marieke Overbeek

      MD, PhD
      Department of Pulmonology, Haaglanden Medisch Centrum
      the Hague, Zuid-Holland, Netherlands

    • MS

      Martijn Spruit

      PhD
      Department of Research & Development, Ciro
      Maastricht, Limburg, Netherlands

    • Erik Klok, MD, PhD, FESC

      Leiden University Medical Center

    Background: Up to half of the acute pulmonary embolism (PE) patients report persistent dyspnea and/or functional limitations despite adequate anticoagulant treatment, qualifying for post-PE syndrome (PPES). Deconditioning due to physical inactivity after acute PE seems to be the most frequent etiology explaining PPES. Depressive disorders and fear for complications or recurrences, may further contribute to this downward spiral. Early exercise training after the acute PE may have positive effects on exercise capacity and quality of life in PE patients.

    Aims: To evaluate the efficacy and safety of exercise training initiated shortly after the acute PE diagnosis on physical performance and the prevention of development of PPES.

    Methods: The PE@HOME study is a randomized controlled, open label clinical trial. Patients with a recent PE diagnosis ( < 4 weeks within start of treatment) who report incomplete functional recovery are eligible to participate. Included patients will perform a cardiopulmonary exercise test (CPET) and constant work rate cycle test (CWRT) at baseline. Patients with a baseline CWRT≤15 minutes will be randomized 1:1 to an 8-week, home-based standardized exercise training program using a cycle ergometer, supervised by a board-certified physiotherapist, or a control group in which patients receive general recommendations on healthy lifestyle and physical activity (Figure 1). After the intervention period, CPET and CWRT will be repeated to assess any improvement over time. Patients are followed for 6 months. The study has been approved by the Institutional Review Board Leiden-Den Haag-Delft.

    Results: The primary objective is to determine the effect of an 8-week exercise training program on physical performance as assessed by CWRT. Secondary objectives include the incidence of PPES as assessed using patient-reported outcome measures, the difference in physical activity and exercise physiology between start and end of the study, cost-effectiveness of the 8-week intervention, and safety of the intervention.

    Conclusion(s): N.A.