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Clinical Trials/NCT04784546
NCT04784546
Completed
Not Applicable

Evaluation of Muscle Strength, Functional Independence, Myalgia Severity, Physical Fatigue and Dyspnea in Patients With COVID-19 Infection

Gazi University1 site in 1 country76 target enrollmentMarch 1, 2021
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Gazi University
Enrollment
76
Locations
1
Primary Endpoint
Change from Baseline Muscle Strength at 1st week, 3rd week and 12th week.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Coronavirus disease 2019 (COVID-19) is a serious, acute infectious disease caused by Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). COVID-19 can manifest itself in a wide variety of clinical scenarios. Asymptomatic disease, mild flu findings, pneumonia accompanied by acute respiratory failure, acute respiratory distress syndrome (ARDS) requiring hospitalization in the intensive care unit, and death are possible clinical consequences.

Myalgia, fatigue, and muscle weakness are reported regardless of the severity of the clinical presentation of COVID-19. Data on the prevalence and severity of muscle disorders and weakness during hospitalization and discharge due to COVID-19 disease are limited.

The aim of this study is to evaluate muscle strength, functional independence, myalgia severity, physical fatigue and dyspnea in hospitalized COVID-19 patients.

Detailed Description

Coronavirus disease 2019 (COVID-19) is a serious, acute infectious disease caused by Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). On March 11, 2020, the World Health Organization declared a pandemic due to COVID-19 disease transmitted from person to person. Positive COVID-19 patients are classified as asymptomatic, mild, moderate, severe and critical. Asymptomatic patients have no clinical symptoms, mild cases present with acute symptoms of respiratory tract infection and gastrointestinal complaints. Moderate patients experience pneumonia, they don't have clinically aberrant hypoxemia but they have positive findings on chest computerized tomography (CT) scans. Severe patients present with pneumonia ,they have hypoxemia and CT lesions while critical patients present with acute respiratory distress syndrome (ARDS), and shock, encephalopathy, myocardial injury, coagulation dysfunction, heart failure, acute kidney injury may accompany ARDS. Myalgia, fatigue, and muscle weakness are reported regardless of the severity of the clinical presentation of COVID-19 disease. Data on the prevalence and severity of muscle disorders and weakness during hospitalization and discharge due to COVID-19 disease are limited. Changes associated with critical disease myopathy triggered by the virus are reported in COVID-19 survivors. In addition, immune-induced focal myofibril atrophy and necrosis have been documented in post-mortem examinations of patients with severe acute respiratory syndrome (SARS). An increase in the risk of acute sarcopenia and muscle weakness has been reported in survivors of COVID-19. Possible mechanisms of sarcopenia in COVID-19 disease are: suppression of muscle protein synthesis due to systemic inflammation and increased cytokine response, prolonged bed rest especially in intensive care patients, prolonged use of muscle relaxants to maintain the prone position, increased need for nutrients due to the catabolic state, inadequate nutrition due to decreased appetite and induction of muscle loss by dexamethasone used in COVID-19 treatment. The aim of this study is to evaluate muscle strength, functional independence, myalgia severity, physical fatigue and dyspnea in hospitalized COVID-19 patients and to investigate whether these variables differ between the mild, moderate and severe groups according to the severity of the disease. The secondary aim of the study is to investigate the relationship between muscle strength and prognostic markers of COVID-19 disease (lymphocyte count, D-dimer, c-reactive protein, ferritin).

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
September 6, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ayça Utkan Karasu

medical doctor, principal investigator

Gazi University

Eligibility Criteria

Inclusion Criteria

  • 18-85 years of age
  • SARS-CoV-2 infection to be confirmed by polymerase chain reaction (PCR) test or presence of serious clinical and radiological suspicion in the endemic process
  • Being hospitalized for COVİD-19 infection

Exclusion Criteria

  • Those who do not agree to participate in the study
  • Malignancy
  • Orthopedic and neurological comorbidities that may interfere with evaluations
  • Systemic rheumatic diseases
  • Pregnancy

Outcomes

Primary Outcomes

Change from Baseline Muscle Strength at 1st week, 3rd week and 12th week.

Time Frame: Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.

Hand grip strength will be used to assess muscle strength. Hand grip strength is an important indicator of overall muscle strength. Measurements will be made with a Jamar dynamometer. Measurements will be done in the standard position recommended by the American Hand Therapists Association; shoulder in adduction and neutral rotation, elbow in 90 degrees of flexion, and wrist in neutral position. 3 measurements will be made with 1-minute intervals between measurements and the highest value will be recorded in kg. Threshold value for hand grip strength is 28.6 in men and 16.4 in women.

Secondary Outcomes

  • Change from Baseline '5 Times Sit to Stand Test' at 1st week, 3rd week and 12th week.(Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.)
  • Change from Baseline Modified Borg Scale at 1st week, 3rd week and 12th week.(Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.)
  • Change from Baseline Barthel Index for Activities of Daily Living at 1st week, 3rd week and 12th week.(Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.)
  • Change from Baseline Visual Analog Scale at 1st week, 3rd week and 12th week.(Patients will be evaluated at the beginning of the inpatient treatment of COVID-19 infection, at the 1st week, 3 rd week and 12 th week.)

Study Sites (1)

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