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

NCT05890560 | Unknown

• 1 other identifier: RECOVER_FollowUp
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Year 2

Secondary Outcomes (2)

• Evaluate the effect of exercise rehabilitation on functional dyspnea

  Year2

• Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation

  Year2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (4)

Centre Hospitalier Victor Dupouy

Argenteuil, France

NOT YET RECRUITING

Fondation Hôpital Saint-Joseph

Paris, 75014, France

RECRUITING

Hôpital Cochin

Paris, 75014, France

NOT YET RECRUITING

Centre Hospitalier André Mignot

Versailles, 78150, France

NOT YET RECRUITING

Related Publications (6)

• 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.

  PMID: 37271020 BACKGROUND

• 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.

  PMID: 22336677 BACKGROUND

• 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.

  PMID: 24132382 BACKGROUND

• 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.

  PMID: 24308899 BACKGROUND

• 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.

  PMID: 18946661 BACKGROUND

• Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008.

  PMID: 28962810 BACKGROUND

MeSH Terms

Conditions

Dyspnea; COVID-19

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Christophe ROMANET

  Fondation Hôpital Saint-Joseph

  STUDY DIRECTOR

Central Study Contacts

Christophe ROMANET

CONTACT

144123085; cromanet@ghpsj.fr

François PHILIPPART, MD

CONTACT

144123085; fphilippart@ghpsj.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 6, 2023
• Study Start: August 14, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

FR (4)