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Effects of Social Isolation From Coronavirus; on Physical Activity, Quality of Life and Stress (COVID-19)

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ClinicalTrials.gov Identifier: NCT04319211
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Eren Avcıl, Istanbul University-Cerrahpasa

Brief 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.

Condition or disease Intervention/treatment
Healthy People Other: Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Investigation of Physical Activity, Quality of Life and Stress Levels of Individuals Who Live in Their Homes Isolated Because of Coronavirus (COVID-19) Disease
Estimated Study Start Date : March 25, 2020
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : July 20, 2020


Group/Cohort Intervention/treatment
People who isolate at home with the danger of coronavirus
Demographic data of the individuals participating in the study will be recorded. 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.
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.




Primary Outcome Measures :
  1. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 4 weeks ]
    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.

  2. Health-Related Quality of Life SF-12 Scale [ Time Frame: 4 weeks ]
    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.

  3. Beck Depression Scale [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
People in the 18-55 age group who live in their homes at risk of Coronavirus.
Criteria

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 ...)

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): NCT04319211


Contacts
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Contact: Eren Avcıl, M.Sc,Pt +9005320683378 erenavcil@gmail.com
Contact: İpek Yeldan, Prof. +9005426513818 ipekyeldan@gmail.com

Locations
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Turkey
Istanbul University Cerrahpasa
Istanbul, Turkey
Contact: Eren Avcıl, M.Sc,Pt    +9005320683378    erenavcil@gmail.com   
Contact: İpek Yeldan, Prof.    +9005426513818    ipekyeldan@gmail.com   
Principal Investigator: İpek Yeldan, Prof.         
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: İpek Yeldan, Prof. Istanbul University-Cerrahpasa
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Responsible Party: Eren Avcıl, M.Sc,Pt, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04319211    
Other Study ID Numbers: EAvcil
İpek Yeldan ( Other Identifier: IstanbulUC )
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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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 Eren Avcıl, Istanbul University-Cerrahpasa:
Coronavirus
Physicial activity
Quality of Life
Stress
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases