Social IsolationNCT04339491
Physical Activity During Social Isolation
An observational study of Social Isolation, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the physical activity level and the factors affecting physical activity among young adults who are socially isolated due to coronavirus. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Isolation
- How many people
- 1,206 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 31 May 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young Adults from Community Sample
Who may be able to join
- Being between the ages of 18-50
- Being volunteer
Who cannot join
- Being unable to communicate in Turkish
- Not knowing read and write in Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Are the Factors That Affect the Physical Activity Levels of Young Adults During Social Isolation Due to Coronavirus?
The aim of the study is to evaluate the physical activity level and the factors affecting physical activity among young adults who are socially isolated due to coronavirus.
- Conditions
- Social Isolation
- Keywords
- physical activity, young adult, coronavirus
- Medical subject headings
- Social Isolation, Motor Activity, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Habit and Factors Affecting Exercise Attendance
It was created by the researchers due to the fact that the existing surveys could not meet the pandemic period. It will be questioned whether the participants had exercise habits in the times before the pandemic. Possible reasons will be questioned according to the positive and negative answers. The answers of the questions are yes / no and they will not be scored. Frequency evaluation will be made according to the results obtained.
Measured: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
Secondary outcomes (4)
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
IPAQ-SF provides information on walking, moderate and vigorous activities and time spent sitting, within a week. There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Measured: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
Exercise Benefits/Barriers Scale
It was developed in response to a need for an instrument to determine perceptions of individuals concerning the benefits and barriers to participating in exercise. The scale, which is a 4-point Likert type, has 4 responses from 4 (strongly agree) to 1 (strongly disagree). The total score of the scale varies between 43-172. Higher scores mean that knowing the benefits of exercise and no barrier to exercise.
Measured: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. It consists of 24 questions, 18 of which are included in the scoring. Each question is scored between 0-3 and the highest total score is 21. The high total score indicates poor sleep quality.
Measured: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
The Hospital Anxiety and Depression Scale
A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety. The questions of the scale, which is a 4-point Likert type, are scored between 0-3. The total score is obtained between 0-21. The high score indicates the presence of depression and anxiety.
Measured: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Apr 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saliha Gürdal Karakelle, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Zengin Alpözgen, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339491
- Sponsor's protocol ID
- 30042020-1
- Status last verified
- Dec 2020
- First submitted
- 3 Apr 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Factors That Affect the Physical Activity Levels of Young Adults During Social Isolation Due to Coronavirus?
- ClinicalTrials.gov ID
- NCT04339491
- Acronym / sponsor ID
- 30042020-1
- Conditions
- Social Isolation
- Keywords
- physical activity, young adult, coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 9 Apr 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 the study is to evaluate the physical activity level and the factors affecting physical activity among young adults who are socially isolated due to coronavirus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young Adults from Community Sample
Key inclusion criteria (2 listed)
- Being between the ages of 18-50
- Being volunteer
Key exclusion criteria (2 listed)
- Being unable to communicate in Turkish
- Not knowing read and write in Turkish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise Habit and Factors Affecting Exercise Attendance
Time frame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
It was created by the researchers due to the fact that the existing surveys could not meet the pandemic period. It will be questioned whether the participants had exercise habits in the times before the pandemic. Possible reasons will be questioned according to the positive and negative answers. The answers of the questions are yes / no and they will not be scored. Frequency evaluation will be made according to the results obtained.
4 secondary outcomes
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
Exercise Benefits/Barriers Scale
Time frame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
The Pittsburgh Sleep Quality Index
Time frame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
The Hospital Anxiety and Depression Scale
Time frame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: No
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Social Isolation in Older Adults, Poverty
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Improving Diet Quality of Community-Dwelling Seniors Using a Community-Based Participatory Approach
Diet Quality, Social Isolation in Older Adults
Recruiting
Social Connection Collective for Older Adults in Subsidized Housing
Social Isolation in Older Adults, Social Isolation or Loneliness
Not yet recruitingObservational study
The Impact of Long-term Isolation in Antarctica on Social Touch and Its Underlying Biological Mechanisms in Winter-over Crew Members, Assessed During Their Stay Using Standardized Touch Stimulation, Computer-based Touch Sensitivity Tests, Questionnaires and Biological Markers.
Social Isolation, Isolated Confined and Extreme Conditions
Active, not recruiting
Enhancing Wellbeing in Community Dwelling Seniors Through Structured Arts-Based Programmes in the Active Ageing Centres: A Mixed Method Study.
Wellbeing, Social Isolation in Older Adults
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.
Ayşe Zengin Alpözgen, PhD 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 Social Isolation, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 30 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Habit and Factors Affecting Exercise Attendance (time frame: The assessment will be made once at baseline, data collection will be completed up to 6 weeks.). 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 30 Dec 2020.