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Pulmonary EmbolismRAMBONCT05015153

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

A study testing Pulmonary rehabilitation (PR) in people with Pulmonary Embolism and Quality of Life and Dyspnea, run by University Hospital, Brest at 6 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pulmonary rehabilitation (PR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
6 sitesFrance
Study dates
11 May 2022to 11 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cécile TROMEUR, PH contact

+33230337602

cecile.tromeur@chu-brest.fr

6 sites in 1 country

France6 sites, 6 recruiting

  • CHU Angers

    Angers, 49100

    Frédéric GAGNADOUX, PU-PH

    Frédéric GAGNADOUX, PU-PH

    Recruiting

  • CHU Brest

    Brest, France, 29609

    Cécile TROMEUR, PH

    Cécile TROMEUR, PH

    Recruiting

  • CHU de Grenoble

    Grenoble, 38048

    Hélène BOUVAIST, 06 85 42 48 43, hbouvaist@chu-grenoble.fr

    Recruiting

  • CHBS Lorient

    Lorient, 56100

    Mikael LE HENAFF, PH

    Mikael LE HENAFF, PH

    Recruiting

  • Hegp (Ap-Hp)

    Paris, 75015

    Benjamin PLANQUETTE, PH

    Benjamin PLANQUETTE, PH

    Recruiting

  • CHU Saint-Etienne

    Saint-Etienne, 42055

    Laurent BERTOLETTI, PU-PH

    Laurent BERTOLETTI, PU-PH

    Recruiting

Other trials in France

About this study

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.

Being tested
Pulmonary rehabilitation (PR)
Medical subject headings
Pulmonary Embolism, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary rehabilitation (PR)Other

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

Study groups in NCT05015153
Study groupRoleWhat they receive
Intervention groupExperimental20 sessions of Pulmonary rehabilitation will be performed over a period of 3 months
Receives: Other: Pulmonary rehabilitation (PR)
Control groupNo interventionNo Pulmonary rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (10)

  1. Safety : number and type of adverse reactions

    Number of events

    Measured: 3 months

  2. 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

    Measured: 15 months

  3. Pulmonary Vascular Obstruction index

    Pulmonary Vascular Obstruction (Meyer score) assessed with V/Q lung scan

    Measured: 3 months

  4. 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)

    Measured: 3 months and 15 months

  5. Change of 6 Minutes Walk Test

    6 Minutes Walk Test

    Measured: 3 months and 15 months

  6. 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)

    Measured: 3 months and 15 months

  7. Symptomatic recurrent PE

    Number of events

    Measured: 15 months

  8. Arterial thromboembolic events

    Number of events

    Measured: 15 months

  9. Deaths of all causes

    Number of events

    Measured: 15 months

  10. Hospitalizations and acute medical events

    Number of events

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start11 May 2022
  3. Primary completion25 Feb 2027 (estimated)
  4. Study completion11 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015153
Sponsor's protocol ID
29BRC21.0093 (RAMBO)
Acronym
RAMBO
Status last verified
Jun 2026
First submitted
11 Aug 2021
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary rehabilitation (PR) in people with Pulmonary Embolism and Quality of Life and Dyspnea, run by University Hospital, Brest at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cécile TROMEUR, PH (+33230337602, cecile.tromeur@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life - PEmbQoL score (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05015153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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