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NCT Number: NCT05381714

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

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.

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Key information

Conditions

COVID-19 Behavior Coronaviridae Infections Coronavirus Infections Dyspnea Infections Lung Diseases Motor Activity Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabuk University

Karabük, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Respiratory Muscle Strength

    Time frame: First Day

    Maximal inspiratory and expiratory muscle strength will be evaluated using portable mouth pressure device.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Peripheral Muscle Strength

    Time frame: Second Day

    Knee extensor muscle strength using portable hand held dynamometer will be evaluated.

  7. Peripheral Muscle Strength

    Time frame: Second Day

    Shoulder abductors muscle strength using portable hand held dynamometer will be evaluated.

  8. 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.

  9. Shortness of breath

    Time frame: First Day

    The Modified Borg Scale will be used to determine dyspnea perception during rest and activity.

  10. 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

  11. 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).

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 19, 2022
Registry last updated
Apr 25, 2023

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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