Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

11. října 2021 aktualizováno: Ayça Utkan Karasu, Gazi University

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

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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).

Typ studie

Pozorovací

Zápis (Aktuální)

76

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Krocan
      • Ankara, Krocan, 06560
        • Gazi University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline Muscle Strength at 1st week, 3rd week and 12th week.
Časové okno: 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.
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline '5 Times Sit to Stand Test' at 1st week, 3rd week and 12th week.
Časové okno: 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.
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.
Change from Baseline Modified Borg Scale at 1st week, 3rd week and 12th week.
Časové okno: 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.
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.
Change from Baseline Barthel Index for Activities of Daily Living at 1st week, 3rd week and 12th week.
Časové okno: 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.
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.
Change from Baseline Visual Analog Scale at 1st week, 3rd week and 12th week.
Časové okno: 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.
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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Gazi University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Zafer Günendi, MD, Gazi University Faculty Of Medicine

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. března 2021

Primární dokončení (Aktuální)

6. září 2021

Dokončení studie (Aktuální)

6. září 2021

Termíny zápisu do studia

První předloženo

1. března 2021

První předloženo, které splnilo kritéria kontroly kvality

4. března 2021

První zveřejněno (Aktuální)

5. března 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. října 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. října 2021

Naposledy ověřeno

1. října 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Gazi University PMR INF

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

There is no plan to make individual participant data (IPD) available to other researchers.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Covid19

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Cote d'Ivoire

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit