Lung Function in Post-COVID-19 Nursing Home Residents

NCT05866211 | Completed

• 1 other identifier: LUNGFUNCTIONCFCR101
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Lung function

  Lung function will be assessed by spirometry.

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• Sociodemographic variables

  Through study completion, an average of 1 year

• Anthropometric variables

  Through study completion, an average of 1 year

• Health variables

  Through study completion, an average of 1 year

• COVID-19 variables

  Through study completion, an average of 1 year

• Fatigue

  Through study completion, an average of 1 year

Study Arms (2)

Case

Individuals with impaired lung function, according to spirometry results (FVC ≤ LLN and FEV1/FVC ≥ LLN).

Other: Previous exposure to SARS-CoV-2

Control

Individuals with normal lung function

Other: Previous exposure to SARS-CoV-2

Interventions

Previous exposure to SARS-CoV-2 OTHER

This is an observational study in which no intervention will be applied.

Case; Control

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Catalan Board of Physiotherapists: collaborator

Study Sites (1)

Faculty of Health Sciences and Welfare

Vic, Barcelona, 08500, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 19, 2023
• Study Start: April 25, 2022
• Primary Completion: November 30, 2022
• Study Completion: January 30, 2024
• Last Updated: December 24, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)