Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836767
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2021-04-07
Brief Title:
Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Evaluation of Exercise Capacity Peripheral Muscle Strength Balance Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 31 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
32 Time of the study It is planned to collect data and write the study between February 2021 and February 2022
33 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
3 Materials and Methods of the Research 31 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
32 Time of the study It is planned to collect data and write the study between February 2021 and February 2022
33 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None