Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study

Last updated: December 13, 2024
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Vascular Diseases

Chest Pain

Treatment

Pulmonary rehabilitation (PR)

Clinical Study ID

NCT05015153
29BRC21.0093 (RAMBO)
  • Ages > 18
  • All Genders

Study Summary

Pulmonary Embolism (PE) is a common and serious disease. Indeed, the annual incidence is 1/1000 patients per year and the 3-month mortality is 10%, which is twice that of myocardial infarction. The treatment is based on anticoagulation for at least 3 months. However, after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases. Several mechanisms explain dyspnea and impairment of quality of life after PE, such as residual pulmonary artery obstruction, exercise deconditioning, depressive syndrome or development of a cardio-respiratory pathology. Pulmonary rehabilitation (PR) has been shown to be effective on dyspnea and quality of life and is included in the therapeutic management of chronic respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis. Furthermore, PR is also used after a myocardial infarction. However, PR after PE is still not included in therapeutic management of PE while outpatient management is recommended for the majority of patients after an acute PE episode. Study hypothesis is that PR has the potential to improve quality of life and dyspnea perception in patients who have received anticoagulation for at least 3 months after PE and who present an impairment of quality of life and/or a persistent dyspnea. This study presents several innovative aspects. First, to our knowledge, This study is the first large randomized trial assessing PR at least 3 months after acute symptomatic PE. Only one small randomized trial on 18 patients evaluating the impact of PR after PE has been published; as PR was performed just after the acute phase of PE in this trial, the clinical status improvement observed in this study could not be explained by PR alone, but also by anticoagulation. In this study, the investigators will include 112 patients at least 3 months after PE in order to exclude the bias related to anticoagulation effect. Second, This study is the first large randomized trial. Third, this study is the first that have the potential to demonstrate efficacy and safety of delayed PR after PE in patients with impaired quality of life due to persistent residual dyspnea.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Patient treated with at least 3 months and up to 8 months of anticoagulation forsymptomatic EP diagnosed according the ESC and ACCP guidelines.

  • Patients who have a PembQol score ≥ 10% and whose total scores for the subgroupsQ7+8 (dyspnea) and Q4 (impact of daily life) are ≥ 10%.

Exclusion

Exclusion Criteria:

  • Presence of CTEPH according to international guidelines

  • Patients treated for acute PE with anticoagulants for more than 8 months

  • Active cancer or in remission for less than two years

  • Dyspnea post - COVID due to parenchymal injuries

  • Post-COVID hyperventilation syndrome without pulmonary vascular perfusion sequelae.

  • Physical or psychological inability to undertake PR

  • Isolated or more distal segmental PE

  • Neuro-muscular disease with PR contraindication.

  • Cardiac insufficiency (unstable coronary artery disease)

  • Severe respiratory failure (long-term oxygen therapy, pulmonary hypertension)

  • Chronic dyspnea MMRC ≥ 2 before PE

  • Cardiac or respiratory rehabilitation in the previous year

  • Indication to urgent PR within 6 months at the time of inclusion

  • Life expectancy of less than 12 months

  • Inability to give consent

  • Patient under guardianship or curatorship

  • Patient deprived of liberty by an administrative or judicial decision

  • Patient has not social security affiliation or who don't beneficiary of such socialsecurity

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: Pulmonary rehabilitation (PR)
Phase:
Study Start date:
May 11, 2022
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • CHU Angers

    Angers, 49100
    France

    Site Not Available

  • CHU Brest

    Brest, 29609
    France

    Active - Recruiting

  • CHU de Grenoble

    Grenoble, 38048
    France

    Active - Recruiting

  • CHBS Lorient

    Lorient, 56100
    France

    Site Not Available

  • CH Morlaix

    Morlaix, 29672
    France

    Site Not Available

  • Hegp (Ap-Hp)

    Paris, 75015
    France

    Site Not Available

  • Centre de santé de Roscoff

    Roscoff, 29684
    France

    Site Not Available

  • CHU Saint-Etienne

    Saint-Etienne, 42055
    France

    Site Not Available

  • CHU Tours

    Tours,
    France

    Site Not Available

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