Post-COVID-19 SyndromeNCT05866211
Lung Function in Post-COVID-19 Nursing Home Residents
An observational study of Post-COVID-19 Syndrome, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
The coronavirus disease 2019 (COVID-19) took a toll in institutionalised older adults, who represent a vulnerable population in European countries. The aim of this study is to identify the predictive factors that worsens lung function in post-COVID nursing home (NH) residents. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Previous exposure to SARS-CoV-2
- How many people
- 184 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2022to 30 Jan 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: The population will be institutionalised older adults previously infected with SARS-CoV-2, either symptomatic or asymptomatic.
Who may be able to join
- male and female
- preserved cognitive function
- previous positive diagnosis of COVID-19 at a minimum of 3 months to the day of data collection
- individuals living permanently in a nursing home
Who cannot join
- individuals in coma or palliative care
- any contraindication to perform spirometry (severe hypertension, myocardial infarction in the past week, non compensated heart failure, etc).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associated Factors for Impaired Lung Function in Post-COVID Nursing Home Residents
The coronavirus disease 2019 (COVID-19) took a toll in institutionalised older adults, who represent a vulnerable population in European countries.
The aim of this study is to identify the predictive factors that worsens lung function in post-COVID nursing home (NH) residents.
Read more
This is a multicenter case-control study in nursing homes of Osona (Catalonia), where individuals with worsened (cases) and normal (controls) lung function will be studied. The inclusion criteria are: female and male from 65 to 95 years old, preserved cognitive capacity and positive diagnosis of COVID-19 at least 3 months prior.
We will assess sociodemographic variables, lung function [spirometry], fatigue [Chalder Fatigue Scale], frailty [Clinical Frailty Scale], and activities of daily living (ADL) [modified Barthel index].
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Previous exposure to SARS-CoV-2
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previous exposure to SARS-CoV-2Other
This is an observational study in which no intervention will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Case | Individuals with impaired lung function, according to spirometry results (FVC ≤ LLN and FEV1/FVC ≥ LLN). Receives: Other: Previous exposure to SARS-CoV-2 | |
| Control | Individuals with normal lung function Receives: Other: Previous exposure to SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Lung function will be assessed by spirometry.
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Sociodemographic variables
Sociodemographic variables (age, gender, length of institutionalization) will be collected through an interview.
Measured: Through study completion, an average of 1 year
Anthropometric variables
Anthropometric variables (weight and height) will be collected by means of a scale and a measuring tape, respectively.
Measured: Through study completion, an average of 1 year
Health variables
Health variables (history of comorbidities) will be collected directly in the medical records of each participant.
Measured: Through study completion, an average of 1 year
COVID-19 variables
The following variables related to COVID-19 will be collected from the medical records of each participant: diagnostic tests (PCR and serological test), suspicious case (symptoms of cough, fever, difficulty breathing, etc.), previous hospitalization for COVID-19 (yes/no, duration), use of mechanical ventilation during hospitalization (yes/no, duration) and vaccination (yes/no, type).
Measured: Through study completion, an average of 1 year
Fatigue
Fatigue levels will be collected using the Chalder Fatigue Scale (CFQ-11)
Measured: Through study completion, an average of 1 year
Frailty
Frailty levels will be assessed using the Clinical Frailty Scale (CFS).
Measured: Through study completion, an average of 1 year
Dependency levels
Dependency levels will be assessed using the Barthel modified index.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start25 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 184 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Board of Physiotherapists
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866211
- Sponsor's protocol ID
- LUNGFUNCTIONCFCR101
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data cannot be shared due to ethical issues regarding patients' privacy according to the Research Ethics Committee of the University of Vic - Central University of Catalonia (Spain). Only the study results may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associated Factors for Impaired Lung Function in Post-COVID Nursing Home Residents
- ClinicalTrials.gov ID
- NCT05866211
- Acronym / sponsor ID
- LUNGFUNCTIONCFCR101
- Conditions
- Post-COVID-19 Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Catalan Board of Physiotherapists
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The coronavirus disease 2019 (COVID-19) took a toll in institutionalised older adults, who represent a vulnerable population in European countries.
The aim of this study is to identify the predictive factors that worsens lung function in post-COVID nursing home (NH) residents.
This is a multicenter case-control study in nursing homes of Osona (Catalonia), where individuals with worsened (cases) and normal (controls) lung function will be studied. The inclusion criteria are: female and male from 65 to 95 years old, preserved cognitive capacity and positive diagnosis of COVID-19 at least 3 months prior.
We will assess sociodemographic variables, lung function [spirometry], fatigue [Chalder Fatigue Scale], frailty [Clinical Frailty Scale], and activities of daily living (ADL) [modified Barthel index].
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Previous exposure to SARS-CoV-2Individuals with impaired lung function, according to spirometry results (FVC ≤ LLN and FEV1/FVC ≥ LLN). |
| Control | – | Other: Previous exposure to SARS-CoV-2Individuals with normal lung function |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The population will be institutionalised older adults previously infected with SARS-CoV-2, either symptomatic or asymptomatic.
Key inclusion criteria (4 listed)
- male and female
- preserved cognitive function
- previous positive diagnosis of COVID-19 at a minimum of 3 months to the day of data collection
- individuals living permanently in a nursing home
Key exclusion criteria (2 listed)
- individuals in coma or palliative care
- any contraindication to perform spirometry (severe hypertension, myocardial infarction in the past week, non compensated heart failure, etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Previous exposure to SARS-CoV-2This is an observational study in which no intervention will be applied. | Other | Case, Control |
Primary outcome
Lung function
Time frame: Through study completion, an average of 1 year
Lung function will be assessed by spirometry.
7 secondary outcomes
Sociodemographic variables
Time frame: Through study completion, an average of 1 year
Anthropometric variables
Time frame: Through study completion, an average of 1 year
Health variables
Time frame: Through study completion, an average of 1 year
COVID-19 variables
Time frame: Through study completion, an average of 1 year
Fatigue
Time frame: Through study completion, an average of 1 year
Frailty
Time frame: Through study completion, an average of 1 year
Dependency levels
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No. Research data cannot be shared due to ethical issues regarding patients' privacy according to the Research Ethics Committee of the University of Vic - Central University of Catalonia (Spain). Only the study results may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-COVID-19 Syndrome, run by University of Vic - Central University of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.