Improving quality of life with pulmonary rehabilitation after pulmonary embolism
Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study
This study is testing whether a structured pulmonary rehabilitation program can help adults who have had a pulmonary embolism feel better and improve their quality of life, even after taking blood thinners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 9 sites (Brest, France and 8 other locations) |
| Trial ID | NCT05015153 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of pulmonary rehabilitation (PR) on patients who have experienced a pulmonary embolism (PE) and continue to suffer from dyspnea and reduced quality of life despite anticoagulation treatment. The intervention involves a structured PR program aimed at alleviating symptoms and enhancing overall well-being. Patients eligible for the study are those aged 18 and older who have been treated with anticoagulants for a specified duration and meet certain quality of life criteria. The study aims to provide evidence for the inclusion of PR in the therapeutic management of PE.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been treated with anticoagulants for pulmonary embolism and have specific quality of life impairments.
Not a fit: Patients with chronic respiratory conditions, severe cardiac insufficiency, or those unable to participate in rehabilitation due to physical or psychological constraints may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and reduce dyspnea in patients recovering from pulmonary embolism.
How similar studies have performed: While pulmonary rehabilitation is established for chronic respiratory diseases, its application post-pulmonary embolism is less common, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brest, France and 8 other locations
- CHU Brest — Brest, France, France (Recruiting)
- CHU Angers — Angers, France (Not_yet_recruiting)
- CHU de Grenoble — Grenoble, France (Recruiting)
- CHBS Lorient — Lorient, France (Not_yet_recruiting)
- CH Morlaix — Morlaix, France (Not_yet_recruiting)
- Hegp (Ap-Hp) — Paris, France (Not_yet_recruiting)
- Centre de santé de Roscoff — Roscoff, France (Not_yet_recruiting)
- CHU Saint-Etienne — Saint-Etienne, France (Not_yet_recruiting)
- CHU Tours — Tours, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Cécile TROMEUR, PH
- Email: cecile.tromeur@chu-brest.fr
- Phone: +33230337602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.