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NCT Number: NCT05866211

Lung Function in Post-COVID-19 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].

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Key information

Conditions

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

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Health Sciences and Welfare

Vic, Barcelona, 08500, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Previous exposure to SARS-CoV-2

Other

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

Primary outcomes

  1. Lung function

    Time frame: Through study completion, an average of 1 year

    Lung function will be assessed by spirometry.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. Fatigue

    Time frame: Through study completion, an average of 1 year

    Fatigue levels will be collected using the Chalder Fatigue Scale (CFQ-11)

  6. Frailty

    Time frame: Through study completion, an average of 1 year

    Frailty levels will be assessed using the Clinical Frailty Scale (CFS).

  7. Dependency levels

    Time frame: Through study completion, an average of 1 year

    Dependency levels will be assessed using the Barthel modified index.

Sponsors and collaborators

Lead sponsor

University of Vic - Central University of Catalonia

Other

Collaborators

  • Catalan Board of Physiotherapists

Registry information

Official study title

Associated Factors for Impaired Lung Function in Post-COVID Nursing Home Residents

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
May 19, 2023
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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