Clinical trial NCT05890560: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dyspnea
COVID-19
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under legal protection

Primary outcomes:
measure: Evaluate the effect of exercise rehabilitation on post-ICU dyspnea
timeFrame: Year 2
Secondary outcomes:
measure: Evaluate the effect of exercise rehabilitation on functional dyspnea
timeFrame: Year2
measure: Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation
timeFrame: Year2
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Paris
country: France
facility: Fondation Hôpital Saint-Joseph
city: Paris
country: France
facility: Hôpital Cochin
city: Versailles
country: France
facility: Centre Hospitalier André Mignot
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Christophe ROMANET
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Schmidt 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.
citation: Rose 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.
citation: Hough 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.
citation: Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008.