ClinicalTrials.gg
RecruitingNCT05015153RAMBOUpdated Jun 16, 2026

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

An interventional study of Pulmonary rehabilitation (PR) in Pulmonary Embolism and Quality of Life and Dyspnea, sponsored by University Hospital, Brest. Recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started May 2022; still recruiting 4 years 6 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 20 studies in Pulmonary Embolism by University Hospital, Brest — 5 open to participants now, 6 under way, none of them phase 3. Pulmonary Embolism · University Hospital, Brest.

Planned enrollment
8th of 11
112 · median 374
Started
2022
the only one that year
No phase
10 of 20
4 open now
Registered
15th of 20
by date

Among the 20 studies in Pulmonary Embolism by University Hospital, Brest, this one is the 8th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2022, is one of 10 with no phase, and was the 15th registered.

Pulmonary Embolism

832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.

Browse Pulmonary Embolism studies →

Open to participants now

5 of the 20 studies in Pulmonary Embolism by University Hospital, Brest are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 129 Pulmonary Embolism studies recruiting now, 109 (84%) set no upper age limit and 5 (4%) stop at 75 or younger; 9 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Pulmonary Embolism
  • Quality of Life and Dyspnea
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • 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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    Intervention group

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

    Other: Pulmonary rehabilitation (PR)

  • No intervention
    Control group

    No Pulmonary rehabilitation

Interventions

  • OtherPulmonary rehabilitation (PR)

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

06

What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. Safety : number and type of adverse reactions

    Number of events

    Time frame: 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

    Time frame: 15 months

  3. Pulmonary Vascular Obstruction index

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

    Time frame: 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)

    Time frame: 3 months and 15 months

  5. Change of 6 Minutes Walk Test

    6 Minutes Walk Test

    Time frame: 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)

    Time frame: 3 months and 15 months

  7. Symptomatic recurrent PE

    Number of events

    Time frame: 15 months

  8. Arterial thromboembolic events

    Number of events

    Time frame: 15 months

  9. Deaths of all causes

    Number of events

    Time frame: 15 months

  10. Hospitalizations and acute medical events

    Number of events

    Time frame: 15 months

07

Study locations

6 of 6 sites recruiting
  • CHU Brest
    Brest, France 29609, France
    Recruiting
    • Cécile TROMEUR, PH · Contact
    • Cécile TROMEUR, PH · Principal investigator
    • Francis COUTURAUD, PU-PH · Sub investigator
    • Aude BARNIER, PH · Sub investigator
    • Christophe GUT-GOBERT, PH · Sub investigator
    • Cécile L'HEVEDER, PH · Sub investigator
    • Christophe LEROYER, PU-PH · Sub investigator
    • Alexandre FAUCHE, PH · Sub investigator
    • Raphael LE MAO, PH · Sub investigator
  • CHU Angers
    Angers, 49100, France
    Recruiting
    • Frédéric GAGNADOUX, PU-PH · Contact
    • Frédéric GAGNADOUX, PU-PH · Principal investigator
  • CHU de Grenoble
    Grenoble, 38048, France
    Recruiting
  • CHBS Lorient
    Lorient, 56100, France
    Recruiting
    • Mikael LE HENAFF, PH · Contact
    • Mikael LE HENAFF, PH · Principal investigator
  • Hegp (Ap-Hp)
    Paris, 75015, France
    Recruiting
    • Benjamin PLANQUETTE, PH · Contact
    • Benjamin PLANQUETTE, PH · Principal investigator
  • CHU Saint-Etienne
    Saint-Etienne, 42055, France
    Recruiting
    • Laurent BERTOLETTI, PU-PH · Contact
    • Laurent BERTOLETTI, PU-PH · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Feb 2027, 57 months after the start.

Of 125 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's planned 57 months is above that.

Counting every sponsor, half of 150 studies reached it within 25 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2021
First posted
Aug 20, 2021
StartActual
May 11, 2022
Primary completionEst.
Feb 25, 2027
CompletionEst.
Feb 11, 2028
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05015153
Responsible party
Sponsor
First posted
Aug 20, 2021
Start date
May 11, 2022
Primary completion
Feb 25, 2027 (estimated)
Completion
Feb 11, 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

Cécile TROMEUR, PH
Contact
cecile.tromeur@chu-brest.fr
+33230337602

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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