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)

June 5, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95107
        • Centre Hospitalier Victor Dupouy
      • Paris, France, 75014
        • Hopital Cochin
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: No specific exercise rehabilitation treatment
After randomization, 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.
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").
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.

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").

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of exercise rehabilitation on post-ICU dyspnea
Time Frame: Month 3
This outcome corresponds to the comparison of Multidimensional Dyspnea Profile (MDP) scale assessment of dyspnea between month 3 and Day 1.
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of exercise rehabilitation on functional dyspnea
Time Frame: Month 3
This outcome corresponds to the comparison of dyspnea on the Modified Medical Research Council (mMRC) scale between month 3 and day1.
Month 3
Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation
Time Frame: Month 3
This outcome corresponds to the comparison of Short-Form Quality of Life Assessment (SF-12) at the end of exercise rehabilitation (Month 3 by comparison day 1).
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: ROMANET Christophe, Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2020

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECOVER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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