Clinical trial NCT04569266: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Keywords: SARS-COV2
Pneumonia
ICU
effort re-training
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluate the effect of exercise rehabilitation on post-ICU dyspnea
timeFrame: Month 3
Secondary outcomes:
measure: Evaluate the effect of exercise rehabilitation on functional dyspnea
timeFrame: Month 3
measure: Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation
timeFrame: Month 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: ROMANET Christophe
role: PRINCIPAL_INVESTIGATOR
References:
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