Healthy PeopleCOVID-19NCT04319211
Effects of Social Isolation From Coronavirus; on Physical Activity, Quality of Life and Stress
An observational study of Healthy People, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Healthy People
- What is being tested?
- Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2020to 20 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: People in the 18-55 age group who live in their homes at risk of Coronavirus.
Who may be able to join
- 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
Who cannot join
- 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 ...)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul
Eren Avcıl, M.Sc,Pt, +9005320683378, erenavcil@gmail.com
İpek Yeldan, Prof., +9005426513818, ipekyeldan@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Healthy People
- Being tested
- Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.
- Keywords
- Coronavirus, Physicial activity, Quality of Life, Stress
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start25 Mar 2020 (estimated)
- Primary completion15 May 2020 (estimated)
- Study completion20 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Avcıl, Istanbul University - Cerrahpasa
- Investigators
- İpek Yeldan, Prof., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319211
- Sponsor's protocol ID
- EAvcil
- Other IDs
- İpek Yeldan
- Acronym
- COVID-19
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04319211
- Acronym / sponsor ID
- COVID-19 / EAvcil
- Conditions
- Healthy People
- Keywords
- Coronavirus, Physicial activity, Quality of Life, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Mar 2020 (estimated)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 20 Jul 2020 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People who isolate at home with the danger of coronavirus | – | Other: Determination of physical activity, quality of life, stress levels of isolated people 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- People in the 18-55 age group who live in their homes at risk of Coronavirus.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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 ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | People who isolate at home with the danger of coronavirus |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İpek Yeldan, Prof. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy People, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eren Avcıl, M.Sc,Pt (+9005320683378, erenavcil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (IPAQ) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.