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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784546
• Other study ID #: Gazi University PMR INF
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 6, 2021

Study information

• Verified date: October 2021
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 COVID-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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Dyspnea
• Fatigue
• Myalgia

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Medicine, Physical Medicine and Rehabilitation Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Bagnato S, Boccagni C, Marino G, Prestandrea C, D'Agostino T, Rubino F. Critical illness myopathy after COVID-19. Int J Infect Dis. 2020 Oct;99:276-278. doi: 10.1016/j.ijid.2020.07.072. Epub 2020 Aug 5. — View Citation

Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847. — View Citation

Leung TW, Wong KS, Hui AC, To KF, Lai ST, Ng WF, Ng HK. Myopathic changes associated with severe acute respiratory syndrome: a postmortem case series. Arch Neurol. 2005 Jul;62(7):1113-7. — View Citation

Paneroni M, Simonelli C, Saleri M, Bertacchini L, Venturelli M, Troosters T, Ambrosino N, Vitacca M. Muscle Strength and Physical Performance in Patients Without Previous Disabilities Recovering From COVID-19 Pneumonia. Am J Phys Med Rehabil. 2021 Feb 1;100(2):105-109. doi: 10.1097/PHM.0000000000001641. — View Citation

Pollard CA, Morran MP, Nestor-Kalinoski AL. The COVID-19 pandemic: a global health crisis. Physiol Genomics. 2020 Nov 1;52(11):549-557. doi: 10.1152/physiolgenomics.00089.2020. Epub 2020 Sep 29. Review. — View Citation

Van Aerde N, Van den Berghe G, Wilmer A, Gosselink R, Hermans G; COVID-19 Consortium. Intensive care unit acquired muscle weakness in COVID-19 patients. Intensive Care Med. 2020 Nov;46(11):2083-2085. doi: 10.1007/s00134-020-06244-7. Epub 2020 Sep 28. — View Citation

Welch C, Greig C, Masud T, Wilson D, Jackson TA. COVID-19 and Acute Sarcopenia. Aging Dis. 2020 Dec 1;11(6):1345-1351. doi: 10.14336/AD.2020.1014. eCollection 2020 Dec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Muscle Strength at 1st week, 3rd week and 12th 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.	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.
Secondary	Change from Baseline '5 Times Sit to Stand Test' at 1st week, 3rd week and 12th week.	The 5 times sit to stand test will be used to assess the functional strength of the lower extremity and balance. The patient is asked to sit in a standard 43-45 cm high chair with his arms crossed on his shoulders and his back leaning against the chair. Then he is asked to stand up and sit up quickly 5 times. With the "start" command, the time elapsed until the person's pelvis touches the chair in the last repetition is recorded with a stopwatch.	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.
Secondary	Change from Baseline Modified Borg Scale at 1st week, 3rd week and 12th week.	This scale has been developed to measure the feeling of exertion and fatigue during physical activity. It is a scale that is frequently used to evaluate the severity of effort dyspnea and the severity of resting dyspnea. It is a 12-point scale that defines the severity of dyspnea according to their degrees. Descriptors are positioned on the scale, at different numbers, from 0 to 10. At one end of the scale '0' is labeled nothing at all' and at the other end, '10' is labeled' maximal.It will be used to measure symptoms of dyspnea and fatigue detected during rest and activities of daily living.	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.
Secondary	Change from Baseline Barthel Index for Activities of Daily Living at 1st week, 3rd week and 12th week.	It is a scale consisting of 10 items and measuring the performance in activities of daily living.Higher scores reflect better ability to function independently.	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.
Secondary	Change from Baseline Visual Analog Scale at 1st week, 3rd week and 12th week.	Myalgia will be assessed by visual analog scale (VAS). A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Two extreme definitions of pain (0: no pain, 10: The most powerful pain one can experience) are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by marking or pointing on this line.	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.