Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study

NCT05015153 | Recruiting

• 1 other identifier: 29BRC21.0093 (RAMBO)
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 9

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.

Conditions

Pulmonary Embolism; Quality of Life and Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Safety : number and type of adverse reactions

  3 months

• Quality of life - PEmbQoL score

  15 months

• Pulmonary Vascular Obstruction index

  3 months

• Incidence of dyspnea

  3 months and 15 months

• Change of 6 Minutes Walk Test

  3 months and 15 months

Study Arms (2)

Intervention group

EXPERIMENTAL

20 sessions of Pulmonary rehabilitation will be performed over a period of 3 months

Other: Pulmonary rehabilitation (PR)

Control group

NO INTERVENTION

No Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation (PR) OTHER

20 sessions of PR in respiratory rehabilitation centre will be performed over a period of 3 months

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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
• Life expectancy of less than 12 months
• Inability to give consent
• Patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (9)

CHU Brest

Brest, France, 29609, France

RECRUITING

CHU Angers

Angers, 49100, France

NOT YET RECRUITING

CHU de Grenoble

Grenoble, 38048, France

RECRUITING

CHBS Lorient

Lorient, 56100, France

NOT YET RECRUITING

CH Morlaix

Morlaix, 29672, France

NOT YET RECRUITING

Hegp (Ap-Hp)

Paris, 75015, France

NOT YET RECRUITING

Centre de santé de Roscoff

Roscoff, 29684, France

NOT YET RECRUITING

CHU Saint-Etienne

Saint-Etienne, 42055, France

NOT YET RECRUITING

CHU Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cécile TROMEUR, PH

CONTACT

+33230337602; cecile.tromeur@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 20, 2021
• Study Start: May 11, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• Access Criteria: 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.

Locations

FR (9)