DyspneaRECOVERNCT04569266
Effectiveness of an Exercise Re-training Program on Dyspnea in Patients After Acute Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia in Post-ICU
A study testing Specific exercise rehabilitation treatment and No specific exercise rehabilitation treatment in people with Dyspnea, run by Fondation Hôpital Saint-Joseph at 3 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
- Conditions the study is for
- Dyspnea
- What is being tested?
- Specific exercise rehabilitation treatment and No specific exercise rehabilitation treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesFrance
- Study dates
- 7 Aug 2020to 30 Apr 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patient whose age ≥ 18 years old
- Patient who has been hospitalized in an intensive care unit and discharged for at least 3 months.
- Patient who has had a laboratory confirmed respiratory infection with SARS-Cov-2 biologically confirmed by PCR or any other commercial or public health test or diagnosed by CT scan.
- Patient who has been undergoing invasive mechanical ventilation or high-flow nasal oxygen therapy during the resuscitation stay for more than 48 consecutive hours
- Francophone Patient
- Patient affiliated to social security or, failing that, to another health insurance system
- Patient capable of giving free, informed and express consent.
Who cannot join
- Lack of possibility of carrying out rehabilitation sessions :
- Presence of contraindications to rehabilitation :
- Severe neurological disease (Parkinson's disease, dementia, amyotrophic lateral sclerosis, aphasia, constituted ischemic stroke with significant sequelae)
- Osteoarticular pathology reducing mobility
- Geographic distance (>5km from the rehabilitation center's reference practice)
- Patient with a mMRC≤1
Show all 9Show fewer
- Patient deprived of liberty
- Patient under guardianship or curatorship
- Patient under the protection of justice
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Victor Dupouy
Argenteuil, 95107
Hôpital Cochin
Paris, 75014
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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 the detailed description
During these episodes of respiratory insufficiency, the management is based on ventilatory replacement by generally invasive mechanical ventilation. This allows correction of hematosis disorders but can lead to complications either directly (respiratory infections) or indirectly (neuromuscular complications and/or complications related to prolonged bed rest requiring prolonged re-education). Although mechanical ventilation makes it possible to improve the objective parameters and contributes considerably to improving the prognosis of these patients, it is nevertheless, despite the progress made, often associated with patient breathlessness due to respiratory pathology and difficulties in optimizing the interaction between the individual and the machine.
Resuscitation will also be associated with amyotrophy due to bed rest, inflammation, reduced metabolic possibilities, especially anabolic ones, and the use of certain treatments (corticosteroids, curares). This muscle loss rapidly affects the diaphragm, then secondarily the peripheral muscles in the context of resuscitation neuromyopathy. On the other hand, complications affecting the entire musculoskeletal system will quickly cause the resuscitation patient to suffer from cardiorespiratory desadaptation, reducing the capacity for exertion on discharge and ultimately resulting in dyspnea on exertion.
In patients surviving the initial condition, dyspnea persists and may be reoccurring months or even years later, despite initial rehabilitation. It is strongly associated with anxiety and even fear of death and contributes to the development of post-traumatic stress disorder. This persistent feeling of respiratory discomfort, which limits the patient's autonomy in his or her daily activities, seems to be able to reduce quality of life. Moreover, the perpetuation of this dyspnea could promote a spiral of deconditioning leading to a progressive deterioration of the cardio-respiratory system, justifying new hospitalizations.
In patients with chronic respiratory insufficiency, exercise rehabilitation supervised by physiotherapists allows, in addition to improving autonomy, a significant reduction in dyspnea, thus increasing the quality of life of these patients.
The study's objective is to evaluate the effect of post-resuscitation respiratory rehabilitation for SARS-Cov-2 in improving dyspnea. Secondly, investigators will seek to evaluate the correlation between quality of life and post-resuscitation dyspnea.
- Conditions
- Dyspnea
- Being tested
- Specific exercise rehabilitation treatment, No specific exercise rehabilitation treatment
- Keywords
- SARS-COV2, Pneumonia, ICU, effort re-training
- Medical subject headings
- Dyspnea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific exercise rehabilitation treatmentOther
Patients meeting the eligibility criteria will be selected consecutively. They will be contacted by telephone after at least 3 months post-resuscitation. The mMRC score is then evaluated. In case of mMRC>1, the study will then be proposed by the physiotherapist or the referring investigating physician of each participating center during this call. The patient is then offered an appointment on the reference rehabilitation platform of each center. The CDM measurement as well as the quality of life by the SF-12 scale are also carried out.
Randomization will be stratified on the type of management during the resuscitation stay (invasive mechanical ventilation/high-flow nasal oxygen therapy) to ensure a good distribution between the 2 study arms ("control" or "treatment").
No specific exercise rehabilitation treatmentOther
Patients meeting the eligibility criteria will be selected consecutively. They will be contacted by telephone after at least 3 months post-resuscitation. The mMRC score is then evaluated. In case of mMRC>1, the study will then be proposed by the physiotherapist or the referring investigating physician of each participating center during this call. The patient is then offered an appointment on the reference rehabilitation platform of each center. The CDM measurement as well as the quality of life by the SF-12 scale are also carried out.
Randomization will be stratified on the type of management during the resuscitation stay (invasive mechanical ventilation/high-flow nasal oxygen therapy) to ensure a good distribution between the 2 study arms ("control" or "treatment").
| Study group | Role | What they receive |
|---|---|---|
| No specific exercise rehabilitation treatment | Other | After randomization, patients will not benefit from any specific exercise rehabilitation treatment until 6 months post-ICU. They will then be proposed to follow the "treatment" protocol if efficacy is demonstrated, once their follow-up in the study is completed. Receives: Other: No specific exercise rehabilitation treatment |
| specific exercise rehabilitation treatment | Experimental | Patients will receive a prescription for exercise rehabilitation, at the rate of 2 sessions of approximately 1 hour each per week for 10 weeks.
Continuous endurance training will start at 60-70% of the patient's maximum power. For patients who are unable to maintain continuous re-training, "interval training" sequences (30 seconds of effort followed by 30 seconds of rest) may be offered.
Initially, the effort will be 15 minutes, then gradually increase to reach an exercise duration of 40 minutes or 45-60 minutes for endurance or interval training respectively.
The power can be adjusted as the patient progresses to reach the target heart rate and dyspnea at 4-6 on the BORG scale.
All patients will be offered lower limb and upper limb strengthening exercises. Each exercise will consist of 3-4 sets of 6-12 repetitions. Receives: Other: Specific exercise rehabilitation treatment |
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 month 3 and Day 1.
Measured: Month 3
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 month 3 and day1.
Measured: Month 3
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-12) at the end of exercise rehabilitation (Month 3 by comparison day 1).
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start7 Aug 2020
- Primary completion3 Nov 2021
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROMANET Christophe, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569266
- Sponsor's protocol ID
- RECOVER
- Acronym
- RECOVER
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parshall 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 22336677Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res. 2004 Jul;14(6):760-78. doi: 10.1177/1049732304265973.
PubMed 15200799Ek K, Andershed B, Sahlberg-Blom E, Ternestedt BM. "The unpredictable death"-The last year of life for patients with advanced COPD: Relatives' stories. Palliat Support Care. 2015 Oct;13(5):1213-22. doi: 10.1017/S1478951514001151. Epub 2014 Oct 15.
PubMed 25315360Davidson AC; British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to? Thorax. 2016 Apr;71(4):297-8. doi: 10.1136/thoraxjnl-2016-208281. No abstract available.
PubMed 26976556Erratum: 'British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to?'. Thorax. 2016 Jun;71(6):492. doi: 10.1136/thoraxjnl-2016-208281corr1. No abstract available.
PubMed 27178824Howell MD, Davis AM. Management of ARDS in Adults. JAMA. 2018 Feb 20;319(7):711-712. doi: 10.1001/jama.2018.0307. No abstract available.
PubMed 29466577Gloeckl R, Marinov B, Pitta F. Practical recommendations for exercise training in patients with COPD. Eur Respir Rev. 2013 Jun 1;22(128):178-86. doi: 10.1183/09059180.00000513.
PubMed 23728873Lacasse Y, Martin S, Lasserson TJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Eura Medicophys. 2007 Dec;43(4):475-85.
PubMed 18084170Schmidt 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 28962810Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.
PubMed 21572329Binks AP, Desjardin S, Riker R. ICU Clinicians Underestimate Breathing Discomfort in Ventilated Subjects. Respir Care. 2017 Feb;62(2):150-155. doi: 10.4187/respcare.04927. Epub 2016 Dec 13.
PubMed 27965421
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Exercise Re-training Program on Dyspnea in Patients After Acute Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia in Post-ICU
- ClinicalTrials.gov ID
- NCT04569266
- Acronym / sponsor ID
- RECOVER / RECOVER
- Conditions
- Dyspnea
- Keywords
- SARS-COV2, Pneumonia, ICU, effort re-training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 29 Sep 2020 (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.
Detailed description
During these episodes of respiratory insufficiency, the management is based on ventilatory replacement by generally invasive mechanical ventilation. This allows correction of hematosis disorders but can lead to complications either directly (respiratory infections) or indirectly (neuromuscular complications and/or complications related to prolonged bed rest requiring prolonged re-education). Although mechanical ventilation makes it possible to improve the objective parameters and contributes considerably to improving the prognosis of these patients, it is nevertheless, despite the progress made, often associated with patient breathlessness due to respiratory pathology and difficulties in optimizing the interaction between the individual and the machine.
Resuscitation will also be associated with amyotrophy due to bed rest, inflammation, reduced metabolic possibilities, especially anabolic ones, and the use of certain treatments (corticosteroids, curares). This muscle loss rapidly affects the diaphragm, then secondarily the peripheral muscles in the context of resuscitation neuromyopathy. On the other hand, complications affecting the entire musculoskeletal system will quickly cause the resuscitation patient to suffer from cardiorespiratory desadaptation, reducing the capacity for exertion on discharge and ultimately resulting in dyspnea on exertion.
In patients surviving the initial condition, dyspnea persists and may be reoccurring months or even years later, despite initial rehabilitation. It is strongly associated with anxiety and even fear of death and contributes to the development of post-traumatic stress disorder. This persistent feeling of respiratory discomfort, which limits the patient's autonomy in his or her daily activities, seems to be able to reduce quality of life. Moreover, the perpetuation of this dyspnea could promote a spiral of deconditioning leading to a progressive deterioration of the cardio-respiratory system, justifying new hospitalizations.
In patients with chronic respiratory insufficiency, exercise rehabilitation supervised by physiotherapists allows, in addition to improving autonomy, a significant reduction in dyspnea, thus increasing the quality of life of these patients.
The study's objective is to evaluate the effect of post-resuscitation respiratory rehabilitation for SARS-Cov-2 in improving dyspnea. Secondly, investigators will seek to evaluate the correlation between quality of life and post-resuscitation dyspnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No specific exercise rehabilitation treatment | Other | Other: No specific exercise rehabilitation treatmentAfter randomization, patients will not benefit from any specific exercise rehabilitation treatment until 6 months post-ICU. They will then be proposed to follow the "treatment" protocol if efficacy is demonstrated, once their follow-up in the study is completed. |
| specific exercise rehabilitation treatment | Experimental | Other: Specific exercise rehabilitation treatmentPatients will receive a prescription for exercise rehabilitation, at the rate of 2 sessions of approximately 1 hour each per week for 10 weeks. Continuous endurance training will start at 60-70% of the patient's maximum power. For patients who are unable to maintain continuous re-training, "interval training" sequences (30 seconds of effort followed by 30 seconds of rest) may be offered. Initially, the effort will be 15 minutes, then gradually increase to reach an exercise duration of 40 minutes or 45-60 minutes for endurance or interval training respectively. The power can be adjusted as the patient progresses to reach the target heart rate and dyspnea at 4-6 on the BORG scale. All patients will be offered lower limb and upper limb strengthening exercises. Each exercise will consist of 3-4 sets of 6-12 repetitions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient whose age ≥ 18 years old
- Patient who has been hospitalized in an intensive care unit and discharged for at least 3 months.
- Patient who has had a laboratory confirmed respiratory infection with SARS-Cov-2 biologically confirmed by PCR or any other commercial or public health test or diagnosed by CT scan.
- Patient who has been undergoing invasive mechanical ventilation or high-flow nasal oxygen therapy during the resuscitation stay for more than 48 consecutive hours
- Francophone Patient
Key exclusion criteria (9 listed)
- Lack of possibility of carrying out rehabilitation sessions :
- Patient with a mMRC≤1
- Patient deprived of liberty
- Patient under guardianship or curatorship
- Patient under the protection of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific exercise rehabilitation treatmentPatients meeting the eligibility criteria will be selected consecutively. They will be contacted by telephone after at least 3 months post-resuscitation. The mMRC score is then evaluated. In case of mMRC>1, the study will then be proposed by the physiotherapist or the referring investigating physician of each participating center during this call. The patient is then offered an appointment on the reference rehabilitation platform of each center. The CDM measurement as well as the quality of life by the SF-12 scale are also carried out. Randomization will be stratified on the type of management during the resuscitation stay (invasive mechanical ventilation/high-flow nasal oxygen therapy) to ensure a good distribution between the 2 study arms ("control" or "treatment"). | Other | specific exercise rehabilitation treatment |
| No specific exercise rehabilitation treatmentPatients meeting the eligibility criteria will be selected consecutively. They will be contacted by telephone after at least 3 months post-resuscitation. The mMRC score is then evaluated. In case of mMRC>1, the study will then be proposed by the physiotherapist or the referring investigating physician of each participating center during this call. The patient is then offered an appointment on the reference rehabilitation platform of each center. The CDM measurement as well as the quality of life by the SF-12 scale are also carried out. Randomization will be stratified on the type of management during the resuscitation stay (invasive mechanical ventilation/high-flow nasal oxygen therapy) to ensure a good distribution between the 2 study arms ("control" or "treatment"). | Other | No specific exercise rehabilitation treatment |
Primary outcome
Evaluate the effect of exercise rehabilitation on post-ICU dyspnea
Time frame: Month 3
This outcome corresponds to the comparison of Multidimensional Dyspnea Profile (MDP) scale assessment of dyspnea between month 3 and Day 1.
2 secondary outcomes
Evaluate the effect of exercise rehabilitation on functional dyspnea
Time frame: Month 3
Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- 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 15200799Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res. 2004 Jul;14(6):760-78. doi: 10.1177/1049732304265973.
- Background: PubMed 25315360Ek K, Andershed B, Sahlberg-Blom E, Ternestedt BM. "The unpredictable death"-The last year of life for patients with advanced COPD: Relatives' stories. Palliat Support Care. 2015 Oct;13(5):1213-22. doi: 10.1017/S1478951514001151. Epub 2014 Oct 15.
- Background: PubMed 26976556Davidson AC; British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to? Thorax. 2016 Apr;71(4):297-8. doi: 10.1136/thoraxjnl-2016-208281. No abstract available.
- Background: PubMed 27178824Erratum: 'British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to?'. Thorax. 2016 Jun;71(6):492. doi: 10.1136/thoraxjnl-2016-208281corr1. No abstract available.
- Background: PubMed 29466577Howell MD, Davis AM. Management of ARDS in Adults. JAMA. 2018 Feb 20;319(7):711-712. doi: 10.1001/jama.2018.0307. No abstract available.
- Background: PubMed 23728873Gloeckl R, Marinov B, Pitta F. Practical recommendations for exercise training in patients with COPD. Eur Respir Rev. 2013 Jun 1;22(128):178-86. doi: 10.1183/09059180.00000513.
- Background: PubMed 18084170Lacasse Y, Martin S, Lasserson TJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Eura Medicophys. 2007 Dec;43(4):475-85.
- 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.
- 1\. Dangers L, Morelot-Panzini C, Schmidt M, Demoule A. Mécanismes neurophysiologiques de la dyspnée : de la perception à la clinique. Réanimation. 2014;23(4):392-401.Link provided by the sponsor.
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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.
ROMANET Christophe principal investigator
Fondation Hôpital Saint-Joseph
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific exercise rehabilitation treatment and No specific exercise rehabilitation treatment in people with Dyspnea, run by Fondation Hôpital Saint-Joseph at 3 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: Month 3). 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 NCT04569266, which also lists 16 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 7 Jun 2023.