Clinical trial NCT04836767: Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term
Official title: Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Covid19
Keywords: COVID-19
SARS-CoV2
pandemic
post-COVID-19
exercise capacity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Incremental shuttle walking test
timeFrame: January,2021 - December,2021
Secondary outcomes:
measure: Time up and Go Test
timeFrame: January,2021 - December,2021
measure: Short form McGill-Melzack Pain Questionnaire
timeFrame: January,2021 - December,2021
measure: Tampa Kinesophobia Questionnaire
timeFrame: January,2021 - December,2021
measure: Hospital Anxiety and Depression Scale
timeFrame: January,2021 - December,2021
measure: SF-36 Quality of Life Scale
timeFrame: January,2021 - December,2021
measure: Fatigue Severity Scale
timeFrame: January,2021 - December,2021
measure: Cognitive Status Scale
timeFrame: January,2021 - December,2021
measure: Body Mass Index
timeFrame: January,2021 - December,2021
measure: Body composition analysis with bioelectrical impedance analysis system
timeFrame: January,2021 - December,2021
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University, Faculty of Medicine
name: Gülay Sain-Guven, Professor
role: STUDY_DIRECTOR
References:
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