Organization of Pulmonary Rehabilitation of Post-COVID-19 Patient With Sequelae (REHABCOVID)

NCT04634318 | Completed

• 2 other identifiers: 2020-CHITS-062020-A02838-31
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

Some patients with COVID-19 have sequelae after the acute phase of infection. These sequelae can be physical (dyspnea, exercise intolerance, abnormal fatigue) but also psychic (anxiety, depression). Systemic sequelae have also been observed in pulmonary, cardiac, hepatic, renal, nervous or immune systems. Respiratory rehabilitation (RR) is indicated in these patients to help their complete recovery without sequelae. These patients' arrival and sanitary constraints imposed by COVID-19 changed the organization of Health Care Centers (HCC). Risk of contagiousness after the acute phase of infection still exists. Consequently, patients must respect a quarantine time on their arrival in HCC and then have no contact with other HCC patients to respect the barrier rules and social distancing measures. HCC accommodation capacities are reduced and this is to the detriment of patients with chronic diseases for whom RR is essential. Certain HCCs saturation can also be responsible for a non-proposal of RR in the care pathway of patients after COVID-19. To cope with the new constraints imposed by Covid-19 pandemic, telemedicine is being developed in the affected industrial countries. Some SRH physicians are starting to offer post-COVID-19 patients the possibility of carrying out a tele-rehabilitation program (TRR). Such a telemedicine program has been validated for people with respiratory failure. It allows the patient to follow his care program without leaving his home and it does not require the visit from a health professional. In addition to reducing the inflow of post COVID-19 patients in HCC, it allows fragile patients to respect social distancing. It could also contain virus spread virus on the territory by reducing patient movements. When choosing between RR and TRR, the clinician must ask himself two questions. Is TRR as efficient as RR for post-COVID-19 patients? Is there a profile of patients for whom either method gives better results? This study proposes to evaluate both methods: a 4-week TRR program vs a conventional RR program in post COVID-19 patients with sequelae. If the hypothesis that both methods have similar effects is verified, this would allow the generalization of the prescription of TRR. The benefits will be individual with greater access to respiratory rehabilitation for post COVID-19 patients. There will also be collective public health benefits by maintaining sufficient access to HCC for patients with chronic diseases.

Conditions

Covid19

Keywords

COVID19; Sequelae; Dyspnea; Exercise intolerance; Respiratory rehabilitation; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Distance walked in the 6-min walk test (6 MWT).

  The 6-min walk test (6 MWT) measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). (ATS Statement: Guidelines for the Six-Minute Walk Test, Am J Respir Crit Care Med, 2002)

  8 weeks

Secondary Outcomes (4)

• Number of repetitions performed in a 1-min Sit-to-Stand (STS) test

  8 weeks

• Dyspnea evaluated by the modified Medical Research Council (mMRC)

  8 weeks

• Fatigue evaluated by the Multidimensional Fatigue Inventory (MFI-20)

  8 weeks

• Anxiety and Depression evaluated by the Hospital Anxiety and Depression Scale (HADS)

  8 weeks

Study Arms (2)

Respiratory rehabilitation program group (RR).

ACTIVE COMPARATOR

Post-COVID-19 patients carrying out a respiratory rehabilitation program (RR).

Other: Respiratory rehabilitation program (RR).

Respiratory tele-rehabilitation program group (TRR).

EXPERIMENTAL

Post-COVID-19 patients carrying out a respiratory tele-rehabilitation program (TRR).

Other: Respiratory tele-rehabilitation program (TRR).

Interventions

Respiratory rehabilitation program (RR). OTHER

Patients in the RR group will follow the respiratory rehabilitation program during a 4-week hospitalization in the respiratory diseases department of Renée Sabran hospital (Hyères, France). The program includes for each week: One medical consultation Four 40-min sessions of aerobic exercises on an ergocycle Four 1-hour sessions of walking in Renée Sabran Hospital's park Three 1-hour sessions of muscle strengthening exercises One 1-hour session of sophrology One 1-hour session of occupational therapy One 1-hour session of psychomotricity

Respiratory rehabilitation program group (RR).

Respiratory tele-rehabilitation program (TRR). OTHER

Patients in the TRR group will realize the 4-week respiratory tele-rehabilitation program at home. The TRR program for each week includes the same sessions as RR program. But, medical consultation, sophrology, occupational therapy, psychomotricity and muscle strengthening sessions are carried out through live videoconferences. Additionally, aerobic and walking sessions are carried out outside home. The intensity of each session will be controlled by heart rate monitor.

Respiratory tele-rehabilitation program group (TRR).

Eligibility Criteria

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

You may qualify if:

• Subjects over 18 years old.
• Subjects having contracted COVID-19 as evidenced by a positive RT-PCR test and / or the presence of antibodies.
• Subjects having had a medical prescription for respiratory rehabilitation.
• Subject having the hardware and network coverage necessary to achieve a videoconference.
• Subjects with at least one of the following post-COVID-19 sequelae:
• Dyspnea at rest or during exercise objectified by the mMRC (modified Medical Research Council) scale with a score greater than or equal to 2. (Vestbo et al, 2013)
• Dysfunction of ventilation objectified by the Nijmegen questionnaire with a score greater than or equal to 23/64 (Van Dixhoorn and Duivenvoordent, 1985)
• Exercise intolerance objectified by the 1min-STS according to the standards by age and sex established by Strassmann et al (2013).
• Abnormal fatigue objectified by the MFI-20 (Multidimensional Fatigue Inventory) validated in French by Gentile et al (2003) according to the age and sex standards established by Schwarz et al (2003).
• State of anxiety or depression objectified by the HADS (Hospital Anxiety and Depression scale) validated in French by Roberge et al (2013) according to the standards by age and sex established by Bocéréan and Ducret (2014)
• Patients covered by social security or equivalent regimen

You may not qualify if:

• Subjects infected again by SARS-CoV-2 during the study as evidenced by a positive RT-PCR test
• Every deterioration of patient physical or psychological state (linked for example to injury or disease) requiring rehabilitation program arrest or incapacity to perform functional tests or to answer questionnaires
• Cardio-vascular contraindications to exercise
• Instability of the respiratory state
• Neuromuscular, osteoarticular or psychiatric disease making exercise impossible
• Person presenting severe depression according to DSM-5 criteria
• Person not mastering enough French language reading and understanding to be able to consent in writing to participate in the study
• Every condition which, according to investigator, might increase or compromise the person security in case of study participation
• Patient with medical history which, according to investigator, might interfere with objective assessment and study results
• Pregnant or breastfeeding women
• Patient deprived of liberty by judicial or administrative decision
• Patient under legal protection measure or not able to express his consent
• Patient not able to follow study procedures and to respect the visits during all study

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (3)

Hôpital Nord (AP-HM)

Marseille, Bouches Du Rhône, 13915, France

Location

Hôpital Renée Sabran

Hyères, Var, 83400, France

Location

HIA Sainte Anne

Toulon, Var, 83000, France

Location

Related Publications (6)

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Crook S, Puhan MA, Frei A; STAND-UP and RIMTCORE study groups. The validation of the sit-to-stand test for COPD patients. Eur Respir J. 2017 Sep 20;50(3):1701506. doi: 10.1183/13993003.01506-2017. Print 2017 Sep. No abstract available.

  PMID: 28931670 BACKGROUND

• Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.

  PMID: 22878278 BACKGROUND

• Schwarz R, Krauss O, Hinz A. Fatigue in the general population. Onkologie. 2003 Apr;26(2):140-4. doi: 10.1159/000069834.

  PMID: 12771522 BACKGROUND

• Roberge P, Dore I, Menear M, Chartrand E, Ciampi A, Duhoux A, Fournier L. A psychometric evaluation of the French Canadian version of the Hospital Anxiety and Depression Scale in a large primary care population. J Affect Disord. 2013 May;147(1-3):171-9. doi: 10.1016/j.jad.2012.10.029. Epub 2012 Dec 4.

  PMID: 23218249 BACKGROUND

• Vallier JM, Simon C, Bronstein A, Dumont M, Jobic A, Paleiron N, Mely L. Randomized controlled trial of home-based vs. hospital-based pulmonary rehabilitation in post COVID-19 patients. Eur J Phys Rehabil Med. 2023 Feb;59(1):103-110. doi: 10.23736/S1973-9087.22.07702-4. Epub 2023 Jan 26.

  PMID: 36700245 RESULT

MeSH Terms

Conditions

COVID-19; Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Marc Vallier, MD

  Toulon University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 18, 2020
• Study Start: December 10, 2020
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: February 9, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)