Lung Function, Exercise Capacity and Health-Related Quality of Life After Severe COVID-19
NCT ID: NCT04410107
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
144 participants
OBSERVATIONAL
2020-05-15
2023-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aims: To evaluate the early (Visit1: 2-6 months after acute disease) and late (Visit 2: 9-15 months and Visit 3: 18-24 months) effects of severe acute respiratory syndrome on lung function, exercise capacity, respiratory symptoms and HRQoL in patients with confirmed diagnosis of SARS-CoV-2 infection.
Material and methods: Prospective cohort of subjects with laboratory confirmed severe COVID-19 (respiratory rate\> 30 breaths/ min; severe respiratory distress; oxyhemoglobin saturation in room air ≤93% or pulmonary involvement\> 50% in chest images). Participants will perform spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide, respiratory system resistance by impulse oscillometry and 6-minute walk test (6MWT) after 2-6 months (Visit 1) , 9-15 months (Visit 2), and 18-24 months (Visit 3) of severe COVID-19. When abnormalities in these pulmonary function tests and/or 6MWT were detected, a cardiopulmonary exercise test will be performed. Clinical, laboratory and chest image data during the severe COVID-19 hospitalization will be obtained from medical records.
The minimum sample size was estimated as 134 participants to assess at least 5 independent factors to predict lung function, HRQoL and exercise capacity at the early assessment. Notwithstanding, the investigators plan to invite to participate all survivors of severe COVID-19 admitted in hospitals of the state of Rio Grande do Sul (Brazil).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Severe Pneumonia
Presence of fever or suspected lower respiratory infection, plus one of the following criteria:
1\) respiratory rate\> 30 movements / min; 2) severe respiratory distress 3) Pulse oximetry (SpO2) ≤93% in room air; and/or 3) Pulmonary infiltrates\> 50% on chest imaging within 24-48hrs of symptom onset.
Lung Function tests
Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS)
Exercise capacity
6-minute walk test (6MWT distance)
Exercise physiology
Cardiopulmonary exercise test (CPET)
Health-related quality of life
Short-Form Health Survey Questionnaire (SF-36)
Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening
1. Adapted translation American Thoracic Society respiratory symptoms questionnaire;
2. Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI);
3. Questionnaire for screening for post-traumatic stress symptoms (PTSD).
Acute respiratory distress syndrome (ARDS)
* Onset: acute, i.e. within 1 week of known clinical insult or new or worsening respiratory symptoms; and
* Chest imaging (e.g. X-ray or CT scan): bilateral opacities, not fully explained by effusions, lobar/lung collapse or nodules; and
* Origin of pulmonary edema: respiratory failure not fully explained by cardiac failure or fluid overload; and
* Degree of hypoxemia: arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤ 300 mm Hg with positive end-expiratory pressure ≥ 5 cm H2O.
Lung Function tests
Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS)
Exercise capacity
6-minute walk test (6MWT distance)
Exercise physiology
Cardiopulmonary exercise test (CPET)
Health-related quality of life
Short-Form Health Survey Questionnaire (SF-36)
Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening
1. Adapted translation American Thoracic Society respiratory symptoms questionnaire;
2. Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI);
3. Questionnaire for screening for post-traumatic stress symptoms (PTSD).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lung Function tests
Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS)
Exercise capacity
6-minute walk test (6MWT distance)
Exercise physiology
Cardiopulmonary exercise test (CPET)
Health-related quality of life
Short-Form Health Survey Questionnaire (SF-36)
Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening
1. Adapted translation American Thoracic Society respiratory symptoms questionnaire;
2. Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI);
3. Questionnaire for screening for post-traumatic stress symptoms (PTSD).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Severe pneumonia defined by the presence of fever or suspected lower respiratory infection, plus one of the following criteria: respiratory rate\> 30 movements/min; severe respiratory distress; SpO2≤93% in room air; or pulmonary infiltrates\>50% on chest imaging within 24-48hrs of acute symptoms onset; and/or
* Acute respiratory distress syndrome (ARDS) defined according to COVID-19 operational management guide of World Health Organization and classified as mild (200 mmHg \<PaO2 / FiO2 ≤ 300 mmHg), moderate (100 mmHg \<PaO2 / FiO2 ≤ 200 mmHg) or severe (PaO2 / FiO2 ≤ 100 mmHg). When the PaO2 is not available, SpO2 / FiO2 ≤ 315 suggests ARDS.
Exclusion Criteria
* Active respiratory tract infection (of any cause); or
* Any clinical condition that prevents the performance of the study procedures.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital de Clinicas de Porto Alegre
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Hospital Moinhos de Vento
OTHER
Federal University of Health Science of Porto Alegre
OTHER
Universidade de Passo Fundo
OTHER
Hospital Nossa Senhora da Conceicao
OTHER
Federal University of Rio Grande do Sul
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Danilo C Berton, MD
Dr
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Danilo C Berton, Dr
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre/Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Univesidade de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Benedetto IG, Silva RMCD, Hetzel GM, Viana GDS, Guimaraes AR, Folador L, Brentano VB, Garcia TS, Ribeiro SP, Dalcin PTR, Gazzana MB, Berton DC. Impact of impaired pulmonary function on clinical outcomes in survivors of severe COVID-19 without pre-existing respiratory disease. J Bras Pneumol. 2023 May 26;49(3):e20220452. doi: 10.36416/1806-3756/e20220452. eCollection 2023.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-0169
Identifier Type: -
Identifier Source: org_study_id