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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2028-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Embolism Quality of Life and Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

20 sessions of Pulmonary rehabilitation will be performed over a period of 3 months

Group Type EXPERIMENTAL

Pulmonary rehabilitation (PR)

Intervention Type OTHER

20 sessions of PR in respiratory rehabilitation centre will be performed over a period of 3 months

Control group

No Pulmonary rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pulmonary rehabilitation (PR)

20 sessions of PR in respiratory rehabilitation centre will be performed over a period of 3 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patient treated with at least 3 months and up to 8 months of anticoagulation for symptomatic EP diagnosed according the ESC and ACCP guidelines.
* Patients who have a PembQol score ≥ 10% and whose total scores for the subgroups Q7+8 (dyspnea) and Q4 (impact of daily life) are ≥ 10%.

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 social security

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Intervention group

Pulmonary rehabilitation (PR)

Control group

Interventions

Pulmonary rehabilitation (PR)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University Hospital, Brest

Responsible Party

Locations

CHU Brest

CHU Angers

CHU de Grenoble

CHBS Lorient

CH Morlaix

Hegp (Ap-Hp)

Centre de santé de Roscoff

CHU Saint-Etienne

CHU Tours

Countries

Central Contacts

Cécile TROMEUR, PH

Facility Contacts

Cécile TROMEUR, PH

Francis COUTURAUD, PU-PH

Aude BARNIER, PH

Christophe GUT-GOBERT, PH

Cécile L'HEVEDER, PH

Christophe LEROYER, PU-PH

Alexandre FAUCHE, PH

Raphael LE MAO, PH

Frédéric GAGNADOUX, PU-PH

Hélène BOUVAIST

Mikael LE HENAFF, PH

Catherine LE BER, PH

Benjamin PLANQUETTE, PH

Sophie RAMEL, PH

Laurent BERTOLETTI, PU-PH

Denis ANGOULVANT, PH

Denis ANGOULVANT, PU-PH

Other Identifiers

29BRC21.0093 (RAMBO)