Impact on Quality of Life With Pulmonary RehAbilitation After Pulmonary eMBOlism: RAMBO Study

Pulmonary Embolism Clinical Trial

— RAMBO  

Official title:

Impact on Quality of Life With Pulmonary RehAbilitation After Pulmonary eMBOlism: RAMBO Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015153
• Other study ID #: 29BRC21.0093 (RAMBO)
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: November 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: Cécile TROMEUR, PH
• Phone: +33230337602
• Email: cecile.tromeur[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: November 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Embolism
• Pulmonary Embolism

Intervention

Other:
• Pulmonary rehabilitation (PR)
20 sessions of PR in respiratory rehabilitation centre will be performed over a period of 3 months

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Brest	Brest
France	CHBS Lorient	Lorient
France	CH Morlaix	Morlaix
France	Hegp (Ap-Hp)	Paris
France	Centre de santé de Roscoff	Roscoff
France	CHU Saint-Etienne	Saint-Etienne
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Safety : number and type of adverse reactions	Number of events	3 months
Secondary	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	15 months
Secondary	Pulmonary Vascular Obstruction index	Pulmonary Vascular Obstruction (Meyer score) assessed with V/Q lung scan	3 months
Secondary	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
Secondary	Change of 6 Minutes Walk Test	6 Minutes Walk Test	3 months and 15 months
Secondary	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
Secondary	Symptomatic recurrent PE	Number of events	15 months
Secondary	Arterial thromboembolic events	Number of events	15 months
Secondary	Deaths of all causes	Number of events	15 months
Secondary	Hospitalizations and acute medical events	Number of events	15 months