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

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ClinicalTrials.gov Identifier: NCT04836767
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Ebru Calik Kutukcu, Hacettepe University

Brief Summary:
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.

Condition or disease
Corona Virus Infection Covid19

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Incremental shuttle walking test [ Time Frame: January,2021 - December,2021 ]
    It assesses maximal exercise capacity.


Secondary Outcome Measures :
  1. Time up and Go Test [ Time Frame: January,2021 - December,2021 ]
    Functional balance and walking capacity

  2. Short form McGill-Melzack Pain Questionnaire [ Time Frame: 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


  3. Tampa Kinesophobia Questionnaire [ Time Frame: January,2021 - December,2021 ]
    Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia

  4. Hospital Anxiety and Depression Scale [ Time Frame: 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

  5. SF-36 Quality of Life Scale [ Time Frame: 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

  6. Fatigue Severity Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception.

  7. Cognitive Status Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure.

  8. Body Mass Index [ Time Frame: 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.

  9. Body composition analysis with bioelectrical impedance analysis system [ Time Frame: January,2021 - December,2021 ]
    FM and FFM ratio



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836767


Locations
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Turkey
Hacettepe University
Ankara, Turkey
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Gülay Sain-Guven, Professor Hacettepe University, Faculty of Medicine
Publications of Results:

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Responsible Party: Ebru Calik Kutukcu, Associate Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT04836767    
Other Study ID Numbers: GO21-178
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ebru Calik Kutukcu, Hacettepe University:
COVID-19
SARS-CoV2
pandemic
post-COVID-19
exercise capacity
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections