Clinical trial NCT05381714: Long-Term Respiratory Muscle Strength in Young COVID-19 Patients
Official title: Long-Term Respiratory and Peripheral Muscle Strength and Respiratory Function in Young COVID-19 Patients: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Muscle Strength
pulmonary function
Physical activity
Dyspnea
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 54 patients with post-COVID-19 and 54 healthy individuals will be included.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Muscle Strength
timeFrame: First Day
Secondary outcomes:
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: First Day
measure: Pulmonary function (Forced vital capacity (FEV1))
timeFrame: First Day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First Day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First Day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First Day
measure: Peripheral Muscle Strength
timeFrame: Second Day
measure: Peripheral Muscle Strength
timeFrame: Second Day
measure: Post-COVID-19 Functional Status
timeFrame: First Day
measure: Shortness of breath
timeFrame: First Day
measure: Fatigue
timeFrame: First Day
measure: Physical Activity
timeFrame: Second Day
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
Study officials:
affiliation: Karabuk University
name: Musa GÜNEŞ, MsC
role: STUDY_CHAIR
affiliation: Karabuk University
name: Metehan YANA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
References:
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