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Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term

6. srpna 2022 aktualizováno: Ebru Calik Kutukcu, Hacettepe University

Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term

The reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, consciousness, work productivity, pain, fear of movement, and quality of life in patients with Covid-19 and to compare them with healthy individuals who have not had COVID-19.

Přehled studie

Postavení

Dokončeno

Detailní popis

In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term exercise capacity, pain, kinesiophobia, peripheral muscle strength, balance, anxiety and depression level, cognitive status and quality of life in individuals with COVID-19. It will also be examined whether these parameters change according to the post-COVID functional restriction level.

3. Materials and Methods of the Research: 3.1. The place of the study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation and Hacettepe University Faculty of Medicine Department of General Internal Medicine

3.2. Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.

3.3. Research population, sample, research group:

The population of the study is individuals who have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19.

The sample of the study is individuals in the long-term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study, and healthy individuals who have not had COVID-19.

Study Design:

Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65, whose education level is at least primary school, and whose local language is Turkish. A total of 40 participants, 20 healthy without COVID-19, and 20 with at least 12 weeks past the diagnosis of COVID-19, will be included in the study. The guidance of the participants will be provided by the relevant physicians of the General Internal Medicine Unit of Hacettepe University Internal Diseases Department.

In accordance with the COVID-19 pandemic precautions, social distance rules will be followed in the tests to be carried out with individuals, care will be taken to use masks, and the materials to be used in tests and measurements will be disinfected before and after use.

COVID-19 Group Inclusion Criteria

  • Having been diagnosed with COVID-19 at least 12 weeks ago,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research,
  • To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
  • Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria

  • Those with an ICU hospitalization history due to the diagnosis of COVID-19,
  • Recent myocardial infarction and pulmonary embolism.
  • Having accompanying chronic diseases,
  • Those who have any orthopedic or neurological disorders that will prevent walking,
  • Another COVID-19 PCR Test positivity in the last 12 weeks,
  • Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,

Healthy Group Inclusion Criteria

  • Not having COVID-19,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research.

The Criteria for Not Including the Healthy Group in the Study

  • Those who have any orthopedic or neuromuscular disorders that will prevent walking,
  • Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

Individuals participating in the study will be informed verbally and in writing about the study protocol and informed consent form will be obtained.

Typ studie

Pozorovací

Zápis (Aktuální)

40

Kontakty a umístění

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

Studijní místa

      • Ankara, Krocan
        • Hacettepe University

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 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

The population of the study is individuals who live in Ankara and have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19.

The sample of the study is healthy individuals in the long term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 and healthy individuals who have not had COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study.

Popis

COVID-19 Group Inclusion Criteria

  • Having been diagnosed with COVID-19 at least 12 weeks ago,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research,
  • To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
  • Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19,

  • Recent myocardial infarction and pulmonary embolism.
  • Having accompanying chronic diseases,
  • Those who have any orthopedic or neurological disorders that will prevent walking,
  • Another COVID-19 PCR Test positivity in the last 12 weeks,
  • Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, Healthy Group Inclusion Criteria
  • Not having COVID-19,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study
  • Those who have any orthopedic or neuromuscular disorders that will prevent walking,
  • Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

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
people with a history of COVID-19

COVID-19 Group Inclusion Criteria

  • Having been diagnosed with COVID-19 at least 12 weeks ago,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research,
  • To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
  • Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria

  • Those with an ICU hospitalization history due to the diagnosis of COVID-19,
  • Recent myocardial infarction and pulmonary embolism.
  • Having accompanying chronic diseases,
  • Those who have any orthopedic or neurological disorders that will prevent walking,
  • Another COVID-19 PCR Test positivity in the last 12 weeks,
  • Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,
healthy people

Healthy Group Inclusion Criteria

  • Not having COVID-19,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study
  • Those who have any orthopedic or neuromuscular disorders that will prevent walking,
  • Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incremental shuttle walking test
Časové okno: January,2021 - December,2021
It assesses maximal exercise capacity.
January,2021 - December,2021

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time up and Go Test
Časové okno: January,2021 - December,2021
Functional balance and walking capacity
January,2021 - December,2021
Short form McGill-Melzack Pain Questionnaire
Časové okno: January,2021 - December,2021

The pain rating index has 2 subscales:

Sensory subscale with 11 words, and Affective subscale with 4 words. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10 cm visual analogue scale (VAS) for average pain.

The higher the total score on the MPQ, the more the pain experience for the patient increases

January,2021 - December,2021
Tampa Kinesophobia Questionnaire
Časové okno: January,2021 - December,2021
Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia
January,2021 - December,2021
Hospital Anxiety and Depression Scale
Časové okno: January,2021 - December,2021
Assessment of anxiety and depression. Scores range from 0 to 21 for each of the two subscales. Higher scores indicate higher level of anxiety and depression
January,2021 - December,2021
SF-36 Quality of Life Scale
Časové okno: January,2021 - December,2021
Assessment of life quality. The scores of each domain ranges from zero to 100 which higher scores indicating higher levels of functioning or well-being
January,2021 - December,2021
Fatigue Severity Scale
Časové okno: January,2021 - December,2021
Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception.
January,2021 - December,2021
Cognitive Status Scale
Časové okno: January,2021 - December,2021
Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure.
January,2021 - December,2021
Body Mass Index
Časové okno: January,2021 - December,2021
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
January,2021 - December,2021
Body composition analysis with bioelectrical impedance analysis system
Časové okno: January,2021 - December,2021
FM and FFM ratio
January,2021 - December,2021

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Gülay Sain-Guven, Professor, Hacettepe 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)

16. února 2021

Primární dokončení (Aktuální)

3. února 2022

Dokončení studie (Aktuální)

3. února 2022

Termíny zápisu do studia

První předloženo

7. dubna 2021

První předloženo, které splnilo kritéria kontroly kvality

7. dubna 2021

První zveřejněno (Aktuální)

8. dubna 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. srpna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. srpna 2022

Naposledy ověřeno

1. srpna 2022

Více informací

Termíny související s touto studií

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

3
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