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

NCT ID: NCT05890560

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2024-12-31

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.

Conditions

Dyspnea; COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Patients in the RECOVER study (NCTT04569266):

• Patient ≥ 18 years old
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe ROMANET

Role: STUDY_DIRECTOR

Fondation Hôpital Saint-Joseph

Locations

Centre Hospitalier Victor Dupouy

Argenteuil, , France

Site Status: NOT_YET_RECRUITING

Fondation Hôpital Saint-Joseph

Paris, , France

Site Status: RECRUITING

Hôpital Cochin

Paris, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier André Mignot

Versailles, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Christophe ROMANET

Role: CONTACT

cromanet@ghpsj.fr

144123085 ext. +33

François PHILIPPART, MD

Role: CONTACT

fphilippart@ghpsj.fr

144123085 ext. +33

Facility Contacts

Gaetan PLANTEFEVE, MD

Role: primary

Christophe Romanet

Role: primary

Frédéric PENE, MD

Role: primary

Alexis FERRE, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 37271020 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22336677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24132382 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24308899 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28962810 (View on PubMed)

Other Identifiers

RECOVER_FollowUp

Identifier Type: -

Identifier Source: org_study_id