Long-Term Respiratory Muscle Strength in Young COVID-19 Patients

April 23, 2023 updated by: Musa Güneş, Karabuk University

Long-Term Respiratory and Peripheral Muscle Strength and Respiratory Function in Young COVID-19 Patients: A Cross-Sectional Study

The coronavirus disease 2019 (COVID-19) is a highly contagious disorder caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 is a multisystem disease and therefore presents a variety of symptoms in the acute phase, such as fever, dry cough, fatigue, sore throat, loss of taste or smell, shortness of breath, nasal congestion, chest pain, muscle or joint pain, headache, and nausea.

COVID-19 primarily affects the respiratory functions of individuals. Although this situation is more difficult in hospitalized patients, it also causes severe effects in individuals who recover with home medication. It is thought that this damage caused by COVID-19 may cause permanent effects on individuals in the long term. During the COVID-19 period, individuals also had to maintain an inactive lifestyle due to quarantine. This decrease in physical activity capacity also causes permanent damage to the respiratory functions of individuals. In addition, studies have focused on this population, as COVID-19 usually affects older individuals. However, considering that young people are also exposed to the COVID-19 virus, the effect on respiratory functions in these individuals should also be examined. Combined with the available information on pulmonary functions, there is insufficient evidence about extrapulmonary features in post-COVID-19 patients who survive mild illness in the long term. It is also necessary to examine whether there is permanent damage to extrapulmonary features such as peripheral muscle strength in these individuals.

Therefore, in our study, it is aimed to examine the long-term results of respiratory functions, respiratory muscle strength and peripheral muscle strength of young individuals who recovered from COVID-19 and recovered from mild disease.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

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

  • Turkey
      • Karabük, Turkey
        • Karabuk University

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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

54 patients with post-COVID-19 and 54 healthy individuals will be included.

Description

Inclusion Criteria:

Patients:

  • diagnosed with COVID-19, with a positive polymerase chain reaction (PCR) test
  • at least six months ago (long term)
  • non-hospitalization due to COVID-19
  • non-smoker / for ex-smokers with 10 pack x years or less of smoking
  • not continuing any regular physical activity program

Controls:

  • non-smoker / for ex-smokers with 10 pack x years or less of smoking,
  • not continuing any regular physical activity program
  • willing to participate to the study

Exclusion Criteria:

  • receiving inpatient or intensive care treatment due to COVID-19
  • having acute infection
  • previous pulmonary resection or cardiac surgery
  • having lung or heart comorbidities such as asthma
  • chronic obstructive pulmonary disease (COPD) and heart failure
  • uncontrolled hypertension
  • history of malignancy
  • neurological disease (e.g., Alzheimer, Multiple Sclerosis, Parkinson)
  • rheumatologic diseases

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Patients
Post-COVID-19 Functional Status (Post-COVID-19 Functional Status Scale), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), physical activity level (International Physical Activity Questionnaire), fatigue (Modified Borg Scale), shortness of breath (Modified Borg Scale) will be evaluated.
Control
Respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), physical activity level (International Physical Activity Questionnaire), fatigue (Modified Borg Scale), shortness of breath (Modified Borg Scale) will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Muscle Strength
Time Frame: First Day
Maximal inspiratory and expiratory muscle strength will be evaluated using portable mouth pressure device.
First Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function (Forced vital capacity (FVC))
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
First Day
Pulmonary function (Forced vital capacity (FEV1))
Time Frame: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1)) [ Time Frame: First Day ] Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
First Day
Pulmonary function (FEV1 / FVC)
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
First Day
Pulmonary function (Peak flow rate (PEF))
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.
First Day
Peripheral Muscle Strength
Time Frame: Second Day
Knee extensor muscle strength using portable hand held dynamometer will be evaluated.
Second Day
Peripheral Muscle Strength
Time Frame: Second Day
Shoulder abductors muscle strength using portable hand held dynamometer will be evaluated.
Second Day
Post-COVID-19 Functional Status
Time Frame: First Day
The post-COVID functional status of individuals recovering from COVID-19 will be evaluated with the Post-COVID-19 Functional Status Scale (PCFS). A minimum of 0 (no functional limitations) and a maximum of 5 (death) points are taken from this scale, and as the score increases, the functional status worsens.
First Day
Shortness of breath
Time Frame: First Day
The Modified Borg Scale will be used to determine dyspnea perception during rest and activity.
First Day
Fatigue
Time Frame: First Day
The Modified Borg Scale will be used to assess fatigue. The lowest 0 points are "not at all" and the highest 10 points are "very severe" denoting fatigue
First Day
Physical Activity
Time Frame: Second Day
Physical activity levels will be used assessed using International Physical Activity Questionnaire. Physical activity levels are classified as physically inactive (<600 MET min/week), low physical activity level (600-3000 MET min/week), and adequate physical activity level (>3000 MET min/week).
Second Day

Collaborators and Investigators

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

Sponsor

Karabuk University

Investigators

  • Study Chair: Musa GÜNEŞ, MsC, Karabuk University
  • Principal Investigator: Metehan Yana, Phd, Karabuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POST-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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