RECOVER_FU: 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

Sponsor

Groupe Hospitalier Paris Saint Joseph (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05890560

Collaborator

(none)

120

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyspnea COVID-19

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Evaluate the effect of exercise rehabilitation on post-ICU dyspnea [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).

Secondary Outcome Measures

Evaluate the effect of exercise rehabilitation on functional dyspnea [Year2]
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.
Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation [Year2]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier Victor Dupouy	Argenteuil	France
2	Fondation Hôpital Saint-Joseph	Paris	France	75014
3	Hôpital Cochin	Paris	France	75014
4	Centre Hospitalier André Mignot	Versailles	France	78150