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

6. August 2022 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

40

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Ankara, Truthahn
        • Hacettepe University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incremental shuttle walking test
Zeitfenster: January,2021 - December,2021
It assesses maximal exercise capacity.
January,2021 - December,2021

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time up and Go Test
Zeitfenster: January,2021 - December,2021
Functional balance and walking capacity
January,2021 - December,2021
Short form McGill-Melzack Pain Questionnaire
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: January,2021 - December,2021
FM and FFM ratio
January,2021 - December,2021

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: Gülay Sain-Guven, Professor, Hacettepe University, Faculty of Medicine

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. Februar 2021

Primärer Abschluss (Tatsächlich)

3. Februar 2022

Studienabschluss (Tatsächlich)

3. Februar 2022

Studienanmeldedaten

Zuerst eingereicht

7. April 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. April 2021

Zuerst gepostet (Tatsächlich)

8. April 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. August 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. August 2022

Zuletzt verifiziert

1. August 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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