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

NCT04569266 | Completed

• 1 other identifier: RECOVER
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Dyspnea

Keywords

SARS-COV2; Pneumonia; ICU; effort re-training

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of exercise rehabilitation on post-ICU dyspnea

  This outcome corresponds to the comparison of Multidimensional Dyspnea Profile (MDP) scale assessment of dyspnea between month 3 and Day 1.

  Month 3

Secondary Outcomes (2)

• Evaluate the effect of exercise rehabilitation on functional dyspnea

  Month 3

• Evaluate the effect of stress rehabilitation on quality of life at the end of exercise rehabilitation

  Month 3

Study Arms (2)

No specific exercise rehabilitation treatment

OTHER

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

specific exercise rehabilitation treatment

EXPERIMENTAL

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

Interventions

Specific exercise rehabilitation treatment OTHER

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").

specific exercise rehabilitation treatment

No specific exercise rehabilitation treatment OTHER

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").

No specific exercise rehabilitation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (3)

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (16)

• Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

  PMID: 22336677 BACKGROUND

• Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res. 2004 Jul;14(6):760-78. doi: 10.1177/1049732304265973.

  PMID: 15200799 BACKGROUND

• Ek K, Andershed B, Sahlberg-Blom E, Ternestedt BM. "The unpredictable death"-The last year of life for patients with advanced COPD: Relatives' stories. Palliat Support Care. 2015 Oct;13(5):1213-22. doi: 10.1017/S1478951514001151. Epub 2014 Oct 15.

  PMID: 25315360 BACKGROUND

• Davidson AC; British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to? Thorax. 2016 Apr;71(4):297-8. doi: 10.1136/thoraxjnl-2016-208281. No abstract available.

  PMID: 26976556 BACKGROUND

• Erratum: 'British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to?'. Thorax. 2016 Jun;71(6):492. doi: 10.1136/thoraxjnl-2016-208281corr1. No abstract available.

  PMID: 27178824 BACKGROUND

• Howell MD, Davis AM. Management of ARDS in Adults. JAMA. 2018 Feb 20;319(7):711-712. doi: 10.1001/jama.2018.0307. No abstract available.

  PMID: 29466577 BACKGROUND

• Gloeckl R, Marinov B, Pitta F. Practical recommendations for exercise training in patients with COPD. Eur Respir Rev. 2013 Jun 1;22(128):178-86. doi: 10.1183/09059180.00000513.

  PMID: 23728873 BACKGROUND

• Lacasse Y, Martin S, Lasserson TJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Eura Medicophys. 2007 Dec;43(4):475-85.

  PMID: 18084170 BACKGROUND

• Schmidt M, Banzett RB, Raux M, Morelot-Panzini C, Dangers L, Similowski T, Demoule A. Unrecognized suffering in the ICU: addressing dyspnea in mechanically ventilated patients. Intensive Care Med. 2014 Jan;40(1):1-10. doi: 10.1007/s00134-013-3117-3. Epub 2013 Oct 17.

  PMID: 24132382 BACKGROUND

• Rose L, Nonoyama M, Rezaie S, Fraser I. Psychological wellbeing, health related quality of life and memories of intensive care and a specialised weaning centre reported by survivors of prolonged mechanical ventilation. Intensive Crit Care Nurs. 2014 Jun;30(3):145-51. doi: 10.1016/j.iccn.2013.11.002. Epub 2013 Dec 3.

  PMID: 24308899 BACKGROUND

• Hough CL, Steinberg KP, Taylor Thompson B, Rubenfeld GD, Hudson LD. Intensive care unit-acquired neuromyopathy and corticosteroids in survivors of persistent ARDS. Intensive Care Med. 2009 Jan;35(1):63-8. doi: 10.1007/s00134-008-1304-4. Epub 2008 Oct 23.

  PMID: 18946661 BACKGROUND

• Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008.

  PMID: 28962810 BACKGROUND

• Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

  PMID: 18367735 BACKGROUND

• Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.

  PMID: 21572329 BACKGROUND

• Binks AP, Desjardin S, Riker R. ICU Clinicians Underestimate Breathing Discomfort in Ventilated Subjects. Respir Care. 2017 Feb;62(2):150-155. doi: 10.4187/respcare.04927. Epub 2016 Dec 13.

  PMID: 27965421 BACKGROUND

• Romanet C, Wormser J, Fels A, Lucas P, Prudat C, Sacco E, Bruel C, Plantefeve G, Pene F, Chatellier G, Philippart F. Effectiveness of exercise training on the dyspnoea of individuals with long COVID: A randomised controlled multicentre trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101765. doi: 10.1016/j.rehab.2023.101765. Epub 2023 Jun 2.

  PMID: 37271020 RESULT

Related Links

• 1\. Dangers L, Morelot-Panzini C, Schmidt M, Demoule A. Mécanismes neurophysiologiques de la dyspnée : de la perception à la clinique. Réanimation. 2014;23(4):392-401.

MeSH Terms

Conditions

Dyspnea; Pneumonia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases

Study Officials

• ROMANET Christophe

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 29, 2020
• Study Start: August 7, 2020
• Primary Completion: November 3, 2021
• Study Completion: April 30, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-02

Locations

FR (3)