Clinical trial NCT04634318: Organization of Pulmonary Rehabilitation of Post-COVID-19 Patient With Sequelae (REHABCOVID)
Official title: Organization of Pulmonary Rehabilitation of Post-COVID-19 Patient With Sequelae. Assessment and Therapeutic Indication of Tele-rehabilitation Versus Conventional Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID19
Sequelae
Dyspnea
Exercise intolerance
Respiratory rehabilitation
Telemedicine
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Some COVID-19 patients have sequelae after infection acute phase. 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. Regional Health Agencies (ARS) have listed Health Care Centers (HCCs) that can welcome these patients. Their arrival and sanitary constraints imposed by COVID-19 changed these HCC organization. Risk of contagiousness after infection acute phase still exists. Consequently, patients must first respect a quarantine time and then have no contact with other HCC patients to respect barrier rules. HCC accommodation capacities are reduced to the detriment of patients with chronic diseases for whom RR is essential. Certain SSRs saturation can also be responsible for a non-proposal of RR to COVID-19 patients. To cope with the new constraints imposed by COVID-19, telemedicine is being developed in affected industrial countries. Some SRH physicians are starting to offer post-COVID-19 patients a tele-rehabilitation program (TRR). Such a program has been validated for people with respiratory failure. It allows a patient to follow his care program without leaving home and it does not require health professional visits. In addition to reducing post COVID-19 patient inflow in HCC, it allows fragile patients to respect social distancing and could contain virus spread on the territory by reducing patient movements. When choosing between RR and TRR, a 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 evaluates both methods: a 4-week TRR program vs a conventional RR program. If the hypothesis that both methods have similar effects is verified, this would allow TRR prescription generalization. Benefits will be individual with greater access to respiratory rehabilitation for post COVID-19 patients. There will also be collective benefits by maintaining sufficient SSR access for patients with chronic diseases.

This study could also help clinicians to choose the best therapeutic methods to combat post COVID-19 sequelae. Indeed, effectiveness study of rehabilitation programs according to medical, physical and psychological patient profile will define what is the most suitable post COVID-19 care method (TRR or RR) for each patient. Thus, it could help to determine the characteristics of the patients for whom a tele-rehabilitation program is indicated.

Sessions carried out in RR and TRR programs are similar. Session number is the same in both programs. They have the same goal and the same intensity. In RR program, sessions are carried out at Renée Sabran Hospital, supervised by medical staff. In TRR program, sessions are carried out at patient's home, supervised by medical staff by video-conference. Additionally, aerobic and walking sessions are carried out outside home. The intensity of each session will be controlled by heart rate monitor.

The same outcome measurements are carried out before and after both respiratory rehabilitation programs. To verify that both respiratory rehabilitation programs have similar efficiency, outcome measures will be analyzed using a 2-factor analysis of variance:

* group (TRR vs RR)
* time (before vs after respiratory rehabilitation program)

Relationship between effectiveness of both respiratory rehabilitation programs and the different characteristics of patients when programs start will be analyzed using multiple linear regression.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 being in the exclusion period of another research protocol at the moment of inclusion
* 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

Primary outcomes:
measure: Distance walked in the 6-min walk test (6 MWT).
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of repetitions performed in a 1-min Sit-to-Stand (STS) test
timeFrame: 8 weeks
measure: Dyspnea evaluated by the modified Medical Research Council (mMRC)
timeFrame: 8 weeks
measure: Fatigue evaluated by the Multidimensional Fatigue Inventory (MFI-20)
timeFrame: 8 weeks
measure: Anxiety and Depression evaluated by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Nord (AP-HM)
state: Bouches Du Rhône
city: Hyères
country: France
facility: Hôpital Renée Sabran
state: Var
city: Toulon
country: France
facility: HIA Sainte Anne
state: Var
Study officials:
affiliation: Toulon University
name: Jean-Marc Vallier, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Schwarz R, Krauss O, Hinz A. Fatigue in the general population. Onkologie. 2003 Apr;26(2):140-4. doi: 10.1159/000069834.
citation: 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.
citation: 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.