Actively Recruiting
Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study
Led by University Hospital, Brest · Updated on 2024-12-16
112
Participants Needed
9
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Treated with anticoagulation for symptomatic pulmonary embolism for at least 3 months and up to 8 months
- PembQol score of 10% or higher, with sub-scores for dyspnea (Q7+8) and impact on daily life (Q4) of 10% or higher
You will not qualify if you...
- Presence of chronic thromboembolic pulmonary hypertension (CTEPH) according to guidelines
- Anticoagulation treatment for acute PE longer than 8 months
- Active cancer or cancer remission less than two years
- Dyspnea due to post-COVID parenchymal lung injury
- Post-COVID hyperventilation syndrome without lung vascular sequelae
- Physical or psychological inability to undergo pulmonary rehabilitation
- Isolated or distal segmental pulmonary embolism
- Neuromuscular disease contraindicating pulmonary rehabilitation
- Unstable coronary artery disease or cardiac insufficiency
- Severe respiratory failure (requiring long-term oxygen or pulmonary hypertension)
- Chronic dyspnea with MMRC score 2 or higher before PE
- Cardiac or respiratory rehabilitation in the previous year
- Urgent indication for pulmonary rehabilitation within 6 months
- Life expectancy less than 12 months
- Inability to give informed consent
- Under guardianship or curatorship
- Deprived of liberty by legal decision
- No social security affiliation or beneficiary status
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Trial Site Locations
Total: 9 locations
1
CHU Brest
Brest, France, France, 29609
Actively Recruiting
2
CHU Angers
Angers, France, 49100
Not Yet Recruiting
3
CHU de Grenoble
Grenoble, France, 38048
Actively Recruiting
4
CHBS Lorient
Lorient, France, 56100
Not Yet Recruiting
5
CH Morlaix
Morlaix, France, 29672
Not Yet Recruiting
6
Hegp (Ap-Hp)
Paris, France, 75015
Not Yet Recruiting
7
Centre de santé de Roscoff
Roscoff, France, 29684
Not Yet Recruiting
8
CHU Saint-Etienne
Saint-Etienne, France, 42055
Not Yet Recruiting
9
CHU Tours
Tours, France
Not Yet Recruiting
Research Team
C
Cécile TROMEUR, PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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