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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 (RECOVER)

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ClinicalTrials.gov Identifier: NCT04569266
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Centre Hospitalier de Versailles André Mignot
Centre Hospitalier Victor Dupouy
Groupe Hospitalo-Universitaire Paris (Hôpital Saint-Anne)
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.


Condition or disease Intervention/treatment Phase
Dyspnea Other: specific exercise rehabilitation treatment Not Applicable

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.

Our objective is to evaluate the effect of post-resuscitation respiratory rehabilitation for SARS-Cov-2 in improving dyspnea. Secondly, we will seek to evaluate the correlation between quality of life and post-resuscitation dyspnea.

Translated with www.DeepL.com/Translator (free version)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : November 7, 2021
Estimated Study Completion Date : May 7, 2022


Arm Intervention/treatment
No Intervention: No specific exercise rehabilitation treatment
Patients will not benefit from any specific exercise rehabilitation treatment until 6 months post-ICU. They will then be proposed to follow the "treatment" protocol if efficacy is demonstrated, once their follow-up in the study is completed.
Experimental: specific exercise rehabilitation treatment

Patients will receive a prescription for exercise rehabilitation, at the rate of 2 sessions of approximately 1 hour each per week for 10 weeks.

Continuous endurance training will start at 60-70% of the patient's maximum power. For patients who are unable to maintain continuous re-training, "interval training" sequences (30 seconds of effort followed by 30 seconds of rest) may be offered.

Initially, the effort will be 15 minutes, then gradually increase to reach an exercise duration of 40 minutes or 45-60 minutes for endurance or interval training respectively.

The power can be adjusted as the patient progresses to reach the target heart rate and dyspnea at 4-6 on the BORG scale.

All patients will be offered lower limb and upper limb strengthening exercises. Each exercise will consist of 3-4 sets of 6-12 repetitions.

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. Patients are then randomized in one of the two groups ("control" or "treatment").




Primary Outcome Measures :
  1. Evaluate the effect of exercise rehabilitation on post-ICU dyspnea [ Time Frame: Day 1 ]
    Multidimensional Dyspnea Profile (MDP) scale assessment of dyspnea

  2. Evaluate the effect of exercise rehabilitation on post-ICU dyspnea [ Time Frame: 3 Months ]
    Multidimensional Dyspnea Profile (MDP) scale assessment of dyspnea


Secondary Outcome Measures :
  1. Evaluate the effect of exercise rehabilitation on functional dyspnea [ Time Frame: Day 1 ]
    Assessment of dyspnea on the Modified Medical Research Council (mMRC) scale

  2. Evaluate the effect of exercise rehabilitation on functional dyspnea [ Time Frame: 3 Months ]
    Assessment of dyspnea on the Modified Medical Research Council (mMRC) scale

  3. Evaluate the effect of stress rehabilitation on quality of life [ Time Frame: Day 1 ]
    Short-Form Quality of Life Assessment (SF-12)

  4. Evaluate the effect of stress rehabilitation on quality of life [ Time Frame: 3 Months ]
    Short-Form Quality of Life Assessment (SF-12)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 during the resuscitation stay for more than 48 consecutive hours.
  • Patient reading or understanding French
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569266


Contacts
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Contact: ROMANET Christophe 01 44 12 30 85 ext +33 cromanet@ghpsj.fr
Contact: PHILIPPART François, MD 01 44 12 30 85 ext +33 fphilippart@ghpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, Ile-de-France, France, 75014
Contact: Helene BEAUSSIER, PharmD, PhD    01 44 12 70 38 ext +33    hbeaussier@ghpsj.fr   
Contact: DRC    01 44 12 70 33 ext +33    crc@ghpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Centre Hospitalier de Versailles André Mignot
Centre Hospitalier Victor Dupouy
Groupe Hospitalo-Universitaire Paris (Hôpital Saint-Anne)
Investigators
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Principal Investigator: ROMANET Christophe Groupe Hospitalier Paris Saint Joseph
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04569266    
Other Study ID Numbers: RECOVER
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
SARS-COV2
Pneumonia
ICU
effort re-training
Additional relevant MeSH terms:
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Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Dyspnea
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Signs and Symptoms, Respiratory