Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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

Study details
    Pulmonary Embolism
    Quality of Life and Dyspnea

NCT05015153

University Hospital, Brest

28 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.