Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT04634318
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04634318
Study Brief:
Protocol Section:
NCT04634318