Lung Function in Post-COVID-19 Nursing Home Residents

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.

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 Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Barcelona
      • Vic, Barcelona, Spain, 08500
        • Faculty of Health Sciences and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population will be institutionalised older adults previously infected with SARS-CoV-2, either symptomatic or asymptomatic.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • individuals in coma or palliative care
  • any contraindication to perform spirometry (severe hypertension, myocardial infarction in the past week, non compensated heart failure, etc).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Individuals with impaired lung function, according to spirometry results (FVC ≤ LLN and FEV1/FVC ≥ LLN).
This is an observational study in which no intervention will be applied.
Control
Individuals with normal lung function
This is an observational study in which no intervention will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: Through study completion, an average of 1 year
Lung function will be assessed by spirometry.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic variables
Time Frame: Through study completion, an average of 1 year
Sociodemographic variables (age, gender, length of institutionalization) will be collected through an interview.
Through study completion, an average of 1 year
Anthropometric variables
Time Frame: Through study completion, an average of 1 year
Anthropometric variables (weight and height) will be collected by means of a scale and a measuring tape, respectively.
Through study completion, an average of 1 year
Health variables
Time Frame: Through study completion, an average of 1 year
Health variables (history of comorbidities) will be collected directly in the medical records of each participant.
Through study completion, an average of 1 year
COVID-19 variables
Time Frame: Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year
Fatigue
Time Frame: Through study completion, an average of 1 year
Fatigue levels will be collected using the Chalder Fatigue Scale (CFQ-11)
Through study completion, an average of 1 year
Frailty
Time Frame: Through study completion, an average of 1 year
Frailty levels will be assessed using the Clinical Frailty Scale (CFS).
Through study completion, an average of 1 year
Dependency levels
Time Frame: Through study completion, an average of 1 year
Dependency levels will be assessed using the Barthel modified index.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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