Clinical trial NCT05015153: Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study
Official title: Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Quality of Life and Dyspnea
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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

Primary outcomes:
measure: Quality of life - PEmbQoL score
timeFrame: 3 months
Secondary outcomes:
measure: Safety : number and type of adverse reactions
timeFrame: 3 months
measure: Quality of life - PEmbQoL score
timeFrame: 15 months
measure: Pulmonary Vascular Obstruction index
timeFrame: 3 months
measure: Incidence of dyspnea
timeFrame: 3 months and 15 months
measure: Change of 6 Minutes Walk Test
timeFrame: 3 months and 15 months
measure: Change of Psychological status
timeFrame: 3 months and 15 months
measure: Symptomatic recurrent PE
timeFrame: 15 months
measure: Arterial thromboembolic events
timeFrame: 15 months
measure: Deaths of all causes
timeFrame: 15 months
measure: Hospitalizations and acute medical events
timeFrame: 15 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU Brest
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lorient
country: France
facility: CHBS Lorient
city: Morlaix
country: France
facility: CH Morlaix
city: Paris
country: France
facility: Hegp (Ap-Hp)
city: Roscoff
country: France
facility: Centre de santé de Roscoff
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
city: Tours
country: France
facility: CHU Tours
Study officials:
References: