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
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.

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.

Completed
Dyspnea

Other: Specific exercise rehabilitation treatment

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").

Other: No specific exercise rehabilitation treatment

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").

Eligibility Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- Patient deprived of liberty

- Patient under guardianship or curatorship

- Patient under the protection of justice

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France

Centre Hospitalier Victor Dupouy
Argenteuil, France

Hôpital Cochin
Paris, France

ROMANET Christophe, Principal Investigator
Groupe Hospitalier Paris Saint Joseph

Groupe Hospitalier Paris Saint Joseph
NCT Number
Keywords
SARS-CoV2
Pneumonia
ICU
effort re-training
MeSH Terms
Pneumonia
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Dyspnea