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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 20 sessions of Pulmonary rehabilitation will be performed over a period of 3 months |
|
| Control group | No Intervention | No Pulmonary rehabilitation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation (PR) | Other | 20 sessions of PR in respiratory rehabilitation centre will be performed over a period of 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life - PEmbQoL score | Pulmonary embolism Quality of life score. This score includes 6 items regarding the frequency of lung complaints, their intensity, their physical, personal, social and professional impact. For each item, an average score is collected | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety : number and type of adverse reactions | Number of events | 3 months |
| Quality of life - PEmbQoL score | Pulmonary embolism Quality of life score. This score includes 6 items regarding the frequency of lung complaints, their intensity, their physical, personal, social and professional impact. For each item, an average score is collected |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile TROMEUR, PH | Contact | +33230337602 | cecile.tromeur@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Recruiting | Brest | France | 29609 | France |
All collected data that underlie results in a publication
Data will be available beginning five years and ending fifteen years following the final study report completion
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| 15 months |
| Pulmonary Vascular Obstruction index | Pulmonary Vascular Obstruction (Meyer score) assessed with V/Q lung scan | 3 months |
| Incidence of dyspnea | Multidimensional dyspnea Profile (MDP) at the cycloergometer, Borg scale at the cycloergometer and at the 6 minute-walk-test, and Modified Medical Research Council scale (MMRC) | 3 months and 15 months |
| Change of 6 Minutes Walk Test | 6 Minutes Walk Test | 3 months and 15 months |
| Change of Psychological status | Score of Hospital Anxiety and Depression scale. 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score for each score = 21) | 3 months and 15 months |
| Symptomatic recurrent PE | Number of events | 15 months |
| Arterial thromboembolic events | Number of events | 15 months |
| Deaths of all causes | Number of events | 15 months |
| Hospitalizations and acute medical events | Number of events | 15 months |
| CHU Angers | Recruiting | Angers | 49100 | France |
|
| CHU de Grenoble | Recruiting | Grenoble | 38048 | France |
|
| CHBS Lorient | Recruiting | Lorient | 56100 | France |
|
| Hegp (Ap-Hp) | Recruiting | Paris | 75015 | France |
|
| CHU Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |