- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319211
Effects of Social Isolation From Coronavirus; on Physical Activity, Quality of Life and Stress (COVID-19)
March 23, 2020 updated by: Eren Avcıl, Istanbul University - Cerrahpasa (IUC)
Investigation of Physical Activity, Quality of Life and Stress Levels of Individuals Who Live in Their Homes Isolated Because of Coronavirus (COVID-19) Disease
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Istanbul University Cerrahpasa
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
N/A
Genders 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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: İpek Yeldan, Prof., Istanbul University - Cerrahpasa (IUC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 25, 2020
Primary Completion (Anticipated)
May 15, 2020
Study Completion (Anticipated)
July 20, 2020
Study Registration Dates
First Submitted
March 20, 2020
First Submitted That Met QC Criteria
March 23, 2020
First Posted (Actual)
March 24, 2020
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EAvcil
- İpek Yeldan (Other Identifier: IstanbulUC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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