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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04319211
Other study ID # EAvcil
Secondary ID Ipek Yeldan
Status Not yet recruiting
Phase
First received
Last updated
Start date March 25, 2020
Est. completion date July 20, 2020

Study information

Verified date March 2020
Source Istanbul University-Cerrahpasa
Contact Eren Avcil, M.Sc,Pt
Phone +9005320683378
Email erenavcil@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of our study is to investigate the physical activity, quality of life and stress levels of individuals living in their homes isolated due to coronavirus (COVID-19) disease. The last three sections of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Parameters such as housework, home care and family care, rest, sports and leisure physical activities, sitting time will be evaluated. Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. Beck Depression Scale will be applied to investigate the stress levels of the individuals participating in our study.


Description:

Coronaviruses (CoV) make up a large family of viruses found in nature. The first CoV of this decade called 2019-nCoV originated in Wuhan, China. On January 30, 2020, the "International Public Health Emergency" was declared by the World Health Organization (WHO). As of February 11, 2020, the data of the World Health Organization (WHO) reported more than 43,000 confirmed cases in 28 countries. As of March 19, 2020, 2019-nCoV reported more than 150 countries, 209,839 cases and 8,778 cases resulted in death. Since efforts to design and develop an antiviral agent will take time to combat the currently occurring coronavirus pathogen, great emphasis is placed on implementing control measures to minimize the risk of 2019-nCoV transmission and spread. Countries have implemented serious interventions to prevent the spread of the disease. Some of those; holiday of schools, cancellation of all crowded meetings, the cancellation of social events and organizations, encouraging citizens to work and stay at home and provide social isolation. Turkey is also taken similar measures to control the outbreak. In this process, people isolate themselves in their homes and live a quiet life away from the social environment. Being away from the social environment and loneliness are among the factors that contribute negatively to the mental health of individuals. It is also an issue associated with quality of life and depressive symptoms. It is uncertain how and how much an individual's isolated life at home affects the level of physical activity. The aim of our study is to investigate the physical activity, quality of life and stress levels of individuals living in their homes isolated due to coronavirus (COVID-19) disease.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date July 20, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Being between the ages of 18-55

- To continue their active education or business life before the social isolation period.

- Spending time at home differently from routine life recently

- Having a smart phone

- Not having visual impairment

- Being literate in Turkish

Exclusion Criteria:

- Mental disability or diagnosed severe psychological discomfort

- Being diagnosed with serious systemic disease (cardiovascular, metabolic, pulmonary…)

- Changing the living conditions in the last 3 months (moving, changing jobs ...)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.
The study will include those who isolate themselves at home for fear of contracting Coronavirus disease or suspected of having it. The last three sections of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Parameters such as housework, home care and family care, rest, sports and leisure physical activities, sitting time will be evaluated. Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. Beck Depression Scale will be applied to investigate the stress levels of the individuals participating in our study.

Locations

Country Name City State
Turkey Istanbul University Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Physical Activity Questionnaire (IPAQ) The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts. 4 weeks
Primary Health-Related Quality of Life SF-12 Scale Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. SF-12 is an easy-to-apply 12-question scale that has been validated and reliable and obtained by shortening and simplifying SF-36, which evaluates the last 4 weeks. 4 weeks
Primary Beck Depression Scale The individuals participating in our study will be evaluated with the Beck Depression Scale developed in 1961 by Beck et al. The scale validity and reliability studies have been conducted in Turkey by Hisli. The scale is a likert-type scale consisting of 21 items, each scored between 0-3. 4 weeks
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