DyspneaRECOVER_FUNCT05890560
Two-year Efficacy of Three Exercise Rehabilitation Strategies on Dyspnea in Patients Who Presented With Secondary Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia
An observational study of Dyspnea and COVID-19, run by Fondation Hôpital Saint-Joseph at 4 sites in France.
Trial summary
Dyspnea is defined by a subjective sensation of respiratory discomfort, the intensity of which varies according to the terrain, the anamnesis and the cause. Resuscitation is associated with many causes of dyspnea, including initial distress, mechanical ventilation, or after-effects following the pathology and its… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Aug 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patient who was under invasive mechanical ventilation during a stay in intensive care in the center of Versailles for more than 48 consecutive hours following infection by SARS-Cov-2 between 01/03/2020 and 26/01/2022, more than 2 years from their release from intensive care
Who may be able to join
- Patients in the RECOVER study (NCTT04569266):
- Patient ≥ 18 years old
- Patient meeting the inclusion criteria for this study (see appendix 1)
- Patient more than 2 years from their release from intensive care
- French-speaking patient
- Patient not objecting to their participation in this research
Show all 13Show fewer
- Usual care patients
- Patient ≥ 18 years old
- Patient having presented a respiratory infection by SARS-Cov-2 confirmed biologically in the laboratory by PCR or any other commercial or public health test or diagnosed by CT scan
- Patient who was under invasive mechanical ventilation during a stay in intensive care in the center of Versailles for more than 48 consecutive hours following infection by SARS-Cov-2 between 01/03/2020 and 26/01/2022
- Patient more than 2 years from their release from intensive care
- French-speaking patient
- Patient not objecting to their participation in this research
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Not yet recruiting
Centre Hospitalier Victor Dupouy
Argenteuil
Gaetan PLANTEFEVE, MD
- Recruiting
Fondation Hôpital Saint-Joseph
Paris, 75014
Christophe Romanet
- Not yet recruiting
Hôpital Cochin
Paris, 75014
Frédéric PENE, MD
- Not yet recruiting
Centre Hospitalier André Mignot
Versailles, 78150
Alexis FERRE, MD
About this study
Official title: Comparison of the Two-year Efficacy of Three Exercise Rehabilitation Strategies on Dyspnea in Patients Who Presented With Secondary Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia
Dyspnea is defined by a subjective sensation of respiratory discomfort, the intensity of which varies according to the terrain, the anamnesis and the cause. Resuscitation is associated with many causes of dyspnea, including initial distress, mechanical ventilation, or after-effects following the pathology and its management.
Respiratory distress is the most severe form of impaired lung function. It is the first cause of hospitalization in intensive care. This distress, indicative of the failure of the respiratory system, is always severe and potentially fatal. It therefore constitutes an absolute therapeutic emergency. Dyspnea is often the revealing symptom of the condition and the urgency surrounding its management is an additional factor of concern for the patient. As a result, dyspnea is a pejorative element associated with severity or even death.
Read more
In patients surviving the initial condition, dyspnea persists and can be found months or even years later, despite the initial rehabilitation. It is strongly associated with anxiety or even the fear of dying and contributes to the occurrence of post-traumatic stress syndromes. This persistent sensation of respiratory discomfort, limiting the patient's autonomy in his activities of daily living, seems to be able to reduce his quality of life. In addition, the perpetuation of this dyspnea could favor a spiral of deconditioning causing a progressive deterioration of the cardio-respiratory system justifying new hospitalizations.
In patients with chronic respiratory failure, exercise rehabilitation supervised by hysiotherapists allows, in addition to improving autonomy, a significant reduction in dyspnoea, thus increasing the quality of life of these patients.
The main objective of this study is to evaluate the effect at 2 years of 3 modes of management of dyspnea: exercise rehabilitation, standard physiotherapy and "usual care" on post-resuscitation dyspnea in patients with presented with severe COVID-19.
- Medical subject headings
- Dyspnea, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of exercise rehabilitation on post-ICU dyspnea
This outcome corresponds to the comparison of Multidimensional Dyspnea Profile (MDP) scale assessment of dyspnea between year 2 and Day 1. The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses in laboratory and clinical settings. The MDP consist of 11 descriptors of breathlessness rated using numerical rating scales (NRS) ranging from 0 to 10. A total score can be summarised as well as an immediate perception subdomain (6 items), and an emotional response subdomain (5 items).
Measured: Year 2
Secondary outcomes (2)
Evaluate the effect of exercise rehabilitation on functional dyspnea
This outcome corresponds to the comparison of dyspnea on the Modified Medical Research Council (mMRC) scale between year 2 and day1. The mMRC (Modified Medical Research Council) Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea. It is useful in characterising baseline dyspnoea in patients.
Measured: Year2
Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation
This outcome corresponds to the comparison of Short-Form Quality of Life Assessment (SF-36) at the end of exercise rehabilitation (Year2 by comparison day 1).
Measured: Year2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start14 Aug 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe ROMANET, Study director, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890560
- Sponsor's protocol ID
- RECOVER_FollowUp
- Acronym
- RECOVER_FU
- Status last verified
- Aug 2023
- First submitted
- 5 Jun 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romanet C, Wormser J, Fels A, Lucas P, Prudat C, Sacco E, Bruel C, Plantefeve G, Pene F, Chatellier G, Philippart F. Effectiveness of exercise training on the dyspnoea of individuals with long COVID: A randomised controlled multicentre trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101765. doi: 10.1016/j.rehab.2023.101765. Epub 2023 Jun 2.
PubMed 37271020Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
PubMed 22336677Schmidt M, Banzett RB, Raux M, Morelot-Panzini C, Dangers L, Similowski T, Demoule A. Unrecognized suffering in the ICU: addressing dyspnea in mechanically ventilated patients. Intensive Care Med. 2014 Jan;40(1):1-10. doi: 10.1007/s00134-013-3117-3. Epub 2013 Oct 17.
PubMed 24132382Rose L, Nonoyama M, Rezaie S, Fraser I. Psychological wellbeing, health related quality of life and memories of intensive care and a specialised weaning centre reported by survivors of prolonged mechanical ventilation. Intensive Crit Care Nurs. 2014 Jun;30(3):145-51. doi: 10.1016/j.iccn.2013.11.002. Epub 2013 Dec 3.
PubMed 24308899Hough CL, Steinberg KP, Taylor Thompson B, Rubenfeld GD, Hudson LD. Intensive care unit-acquired neuromyopathy and corticosteroids in survivors of persistent ARDS. Intensive Care Med. 2009 Jan;35(1):63-8. doi: 10.1007/s00134-008-1304-4. Epub 2008 Oct 23.
PubMed 18946661Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008.
PubMed 28962810
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Two-year Efficacy of Three Exercise Rehabilitation Strategies on Dyspnea in Patients Who Presented With Secondary Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05890560
- Acronym / sponsor ID
- RECOVER_FU / RECOVER_FollowUp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dyspnea is defined by a subjective sensation of respiratory discomfort, the intensity of which varies according to the terrain, the anamnesis and the cause. Resuscitation is associated with many causes of dyspnea, including initial distress, mechanical ventilation, or after-effects following the pathology and its management.
Respiratory distress is the most severe form of impaired lung function. It is the first cause of hospitalization in intensive care. This distress, indicative of the failure of the respiratory system, is always severe and potentially fatal. It therefore constitutes an absolute therapeutic emergency. Dyspnea is often the revealing symptom of the condition and the urgency surrounding its management is an additional factor of concern for the patient. As a result, dyspnea is a pejorative element associated with severity or even death.
In patients surviving the initial condition, dyspnea persists and can be found months or even years later, despite the initial rehabilitation. It is strongly associated with anxiety or even the fear of dying and contributes to the occurrence of post-traumatic stress syndromes. This persistent sensation of respiratory discomfort, limiting the patient's autonomy in his activities of daily living, seems to be able to reduce his quality of life. In addition, the perpetuation of this dyspnea could favor a spiral of deconditioning causing a progressive deterioration of the cardio-respiratory system justifying new hospitalizations.
In patients with chronic respiratory failure, exercise rehabilitation supervised by hysiotherapists allows, in addition to improving autonomy, a significant reduction in dyspnoea, thus increasing the quality of life of these patients.
The main objective of this study is to evaluate the effect at 2 years of 3 modes of management of dyspnea: exercise rehabilitation, standard physiotherapy and "usual care" on post-resuscitation dyspnea in patients with presented with severe COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who was under invasive mechanical ventilation during a stay in intensive care in the center of Versailles for more than 48 consecutive hours following infection by SARS-Cov-2 between 01/03/2020 and 26/01/2022, more than 2 years from their release from intensive care
Key inclusion criteria (13 listed)
- Patient ≥ 18 years old
- Patient meeting the inclusion criteria for this study (see appendix 1)
- Patient more than 2 years from their release from intensive care
- French-speaking patient
- Patient not objecting to their participation in this research
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the effect of exercise rehabilitation on post-ICU dyspnea
Time frame: Year 2
This outcome corresponds to the comparison of Multidimensional Dyspnea Profile (MDP) scale assessment of dyspnea between year 2 and Day 1. The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses in laboratory and clinical settings. The MDP consist of 11 descriptors of breathlessness rated using numerical rating scales (NRS) ranging from 0 to 10. A total score can be summarised as well as an immediate perception subdomain (6 items), and an emotional response subdomain (5 items).
2 secondary outcomes
Evaluate the effect of exercise rehabilitation on functional dyspnea
Time frame: Year2
Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation
Time frame: Year2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 37271020Romanet C, Wormser J, Fels A, Lucas P, Prudat C, Sacco E, Bruel C, Plantefeve G, Pene F, Chatellier G, Philippart F. Effectiveness of exercise training on the dyspnoea of individuals with long COVID: A randomised controlled multicentre trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101765. doi: 10.1016/j.rehab.2023.101765. Epub 2023 Jun 2.
- Background: PubMed 22336677Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
- Background: PubMed 24132382Schmidt M, Banzett RB, Raux M, Morelot-Panzini C, Dangers L, Similowski T, Demoule A. Unrecognized suffering in the ICU: addressing dyspnea in mechanically ventilated patients. Intensive Care Med. 2014 Jan;40(1):1-10. doi: 10.1007/s00134-013-3117-3. Epub 2013 Oct 17.
- Background: PubMed 24308899Rose L, Nonoyama M, Rezaie S, Fraser I. Psychological wellbeing, health related quality of life and memories of intensive care and a specialised weaning centre reported by survivors of prolonged mechanical ventilation. Intensive Crit Care Nurs. 2014 Jun;30(3):145-51. doi: 10.1016/j.iccn.2013.11.002. Epub 2013 Dec 3.
- Background: PubMed 18946661Hough CL, Steinberg KP, Taylor Thompson B, Rubenfeld GD, Hudson LD. Intensive care unit-acquired neuromyopathy and corticosteroids in survivors of persistent ARDS. Intensive Care Med. 2009 Jan;35(1):63-8. doi: 10.1007/s00134-008-1304-4. Epub 2008 Oct 23.
- Background: PubMed 28962810Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe ROMANET study director
Fondation Hôpital Saint-Joseph
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and COVID-19, run by Fondation Hôpital Saint-Joseph at 4 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 13 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe ROMANET (144123085 ext. +33, cromanet@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of exercise rehabilitation on post-ICU dyspnea (time frame: Year 2). 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 NCT05890560, which also lists 6 linked publications.
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 1 Sep 2023.