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

NCT04784546 | Completed

• 1 other identifier: Gazi University PMR INF
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

covid19; muscle weakness; functional independence; myalgia; fatigue; dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (3)

Mild COVID-19 Infection Group

Mild cases present with acute symptoms of respiratory tract infection and gastrointestinal complaints.

Moderate COVID-19 Infection Group

Moderate patients experience pneumonia, they don't have clinically aberrant hypoxemia(O2 saturation is more than 90%) but they have positive findings on chest computerized tomography (CT) scans.

Severe COVID-19 Infection Group

Severe patients present with pneumonia, they have hypoxemia (O2 saturation is less than 90%) and have positive findings on chest computerized tomography (CT) scans.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study cohort will consist of patients receiving inpatient treatment for mild, moderate and severe COVID-19 infection in a university hospital. Every subject meeting the criteria of inclusion is going to be included into the study via consecutive participant sampling method.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 32991251 BACKGROUND

• 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.

  PMID: 33181531 BACKGROUND

• 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. No abstract available.

  PMID: 32986233 BACKGROUND

• 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. doi: 10.1001/archneur.62.7.1113.

  PMID: 16009768 BACKGROUND

• 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.

  PMID: 32675661 BACKGROUND

• 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.

  PMID: 32763444 BACKGROUND

• 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.

  PMID: 33269092 BACKGROUND

• Karasu AU, Karatas L, Yildiz Y, Gunendi Z. Natural Course of Muscular Strength, Physical Performance, and Musculoskeletal Symptoms in Hospitalized Patients With COVID-19. Arch Phys Med Rehabil. 2023 Jan;104(1):18-26. doi: 10.1016/j.apmr.2022.09.001. Epub 2022 Sep 11.

  PMID: 36103903 DERIVED

MeSH Terms

Conditions

COVID-19; Muscle Weakness; Myalgia; Fatigue; Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuromuscular Diseases; Musculoskeletal Pain; Pain; Respiration Disorders; Signs and Symptoms, Respiratory

Study Officials

• Ayça Utkan Karasu, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Zafer Günendi, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, principal investigator

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 5, 2021
• Study Start: March 1, 2021
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)