Physical ActivityNCT06551025
Comparison of Clinical Parameters in Individuals With Different Physical Activity Levels During the COVID-19 Pandemic Period
An observational study of Physical Activity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The COVID-19 pandemic started in China towards the end of 2019 and soon affected the whole world. Restriction and isolation measures have been taken to prevent the spread of this disease caused by a new type of coronavirus, coronavirus-2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2021to 30 Aug 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study is healthy individuals whose physical activity level was determined according to the results of the International Physical Activity Questionnare (IPAQ). The sample of the study is healthy individuals whose physical activity level is inactive and minimally/heavily active according to the results of the International Physical Activity Questionnare (IPAQ).
Who may be able to join
- Being between the ages of 18-65
- Being able to cooperate with the tests
- Not have any known acute or chronic health problems that may prevent them from performing the tests or affect the test performance.
- Not having any known acute or chronic disease that may affect the balance status.
- Not having orthopedic, neurological and serious cardiovascular problems that will affect the performance of the sit-stand test for 1 minute
- Volunteering to participate in the study
Show all 10Show fewer
- Having access to a phone or video conferencing platform with a reliable internet connection with their own device
- To have the ability to operate these devices independently or with the help of another individual
- Have adequate hearing function and language knowledge
- Be able to move independently and safely even with walking aid
Who cannot join
- Not cooperating with the tests
- Known information that may prevent it from performing tests or affect test performance have acute and chronic health problems
- Known acute and chronic illness that may affect balance
- Have angina and ischemic heart disease onset at rest or with minimal effort
- Have a cognitive impairment
- Risk of falling and having poor balance Not having access to a phone or video conferencing platform with a reliable internet connection with their own device
Show all 9Show fewer
- Not having sufficient hearing function and language knowledge
- Not being able to move independently and safely even with walking aid
- Not being willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Balance, Exercise Capacity, Sleep Quality and Coronavirus Phobia in Individuals With Different Physical Activity Levels During the COVID-19 Pandemic Period
The COVID-19 pandemic started in China towards the end of 2019 and soon affected the whole world. Restriction and isolation measures have been taken to prevent the spread of this disease caused by a new type of coronavirus, coronavirus-2. These measures have changed people's physical activity levels and have also affected other parameters that physical activity affects. This study aims comparison of clinical parameters in with different physical activity levels during the COVID-19 pandemic period.
Read the detailed description
In our study, the investigators aimed to compare balance, exercise capacity, sleep quality and coronavirus phobia levels and investigate the relationship between exercise capacity and balance in individuals with different physical activity levels during the COVID-19 pandemic period.
Materials and Methods of the Research:
The place of study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation.
Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.
Research Population, Sample, Research Group:
The population of the study is healthy individuals whose physical activity level was determined according to the results of the International Physical Activity Questionnare (IPAQ).
The sample of the study is healthy individuals whose physical activity level is inactive and minimally/heavily active according to the results of the International Physical Activity Questionnare (IPAQ).
Study Design:
Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65 and whose local language is Turkish. A total of 64 participants, 32 inactive and 32 minimally/heavily active, will be included in the study.
Evaluations will be made using tele-assessment methods, not face-to-face due to the COVID-19 pandemic. Verbal informed consent will be obtained from all subjects by video interview method that they voluntarily participated in the study. Written informed consent will be obtained from the cases whose verbal consent has been obtained.
Inclusion Criteria:
- Being between the ages of 18-65
- Being able to cooperate with the tests
- Not have any known acute or chronic health problems that may prevent them from performing the tests or affect the test performance.
- Not having any known acute or chronic disease that may affect the balance status.
- Not having orthopedic, neurological and serious cardiovascular problems that will affect the performance of the sit-stand test for 1 minute
- Volunteering to participate in the study
- Having access to a phone or video conferencing platform with a reliable internet connection with their own device
- To have the ability to operate these devices independently or with the help of another individual
- Have adequate hearing function and language knowledge
- Be able to move independently and safely even with walking aid
Exclusion Criteria:
- Not cooperating with the tests
- Known information that may prevent it from performing tests or affect test performance have acute and chronic health problems
- Known acute and chronic illness that may affect balance
- Have angina and ischemic heart disease onset at rest or with minimal effort
- Have a cognitive impairment
- Risk of falling and having poor balance Not having access to a phone or video conferencing platform with a reliable internet connection with their own device
- Not having sufficient hearing function and language knowledge
- Not being able to move independently and safely even with walking aid
- Not being willing to participate in the study
- Conditions
- Physical Activity
- Keywords
- adult, exercise, sleep, COVID-19
- Medical subject headings
- Motor Activity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inactive | Individuals with physical activity levels of 0-600 METs according to the results of the International Physical Activity Scale (IPAQ). | |
| Minimally/Heavily active | Individuals with physical activity levels of 600-3000 METs or 3000 METs and above according to the results of the International Physical Activity Scale (IPAQ). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
The 1 minute sit-to-stand test is one of the tests that evaluates exercise capacity.In this test, the number of sitting and standing repetitions in a chair for 1 minute is recorded. Heart rate, shortness of breath, and fatigue perceptions will be recorded before and after the test.
Measured: March,2021- August,2021
Physical Activity
The International Physical Activity Questionnare (IPAQ)- Short form assesses the level of physical activity.The short form consists of seven questions. It provides information on sitting, walking, moderately vigorous activities, and time spent in vigorous activities.
Measured: March,2021- August,2021
Cognitive Function
The standardized mini mental test is a test that evaluates the suitability of individuals' cognitive functions for tele-assessment. It consists of eleven items gathered under five main headings: orientation, recording memory, attention and calculation, recall and language.
Measured: March,2021- August,2021
Coronavirus Phobia
The Coronavirus 19 Phobia Scale (C19P-S) is a scale that evaluates coronavirus phobia. C19P-S is a five-point Likert-type self-assessment scale developed to measure phobia against coronavirus. The test has psychological, somatic, social and economic sub-dimensions.
Measured: March,2021- August,2021
Sleep Quality
The Pittsburgh Sleep Quality Scale (PSQI) is one of the scales that evaluates sleep quality. PSQI is a self-reported screening and evaluation test that provides information about the type and severity of sleep quality disturbances and sleep structure problems.
Measured: March,2021- August,2021
Health Literacy
Turkish Health Literacy Scale-32 (TSOY-32) is a scale consisting of 32 questions and evaluating health literacy. The scale, based on the conceptual framework developed by the European Health Literacy Research Consortium, was developed by Okyay et al. to assess health literacy among literate people over the age of 15.
Measured: March,2021- August,2021
Balance
Berg Balance Scale is a scale used to evaluate dynamic and static balance skills. It consists of 14 activities that require balance skills in different positions such as standing, sitting, and standing on one leg.
Measured: March,2021- August,2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start27 Mar 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Cansu Özkılıçaslan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551025
- Sponsor's protocol ID
- GO21/56
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balance, Exercise Capacity, Sleep Quality and Coronavirus Phobia in Individuals With Different Physical Activity Levels During the COVID-19 Pandemic Period
- ClinicalTrials.gov ID
- NCT06551025
- Acronym / sponsor ID
- GO21/56
- Conditions
- Physical Activity
- Keywords
- adult, exercise, sleep, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 27 Mar 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 13 Aug 2024 (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 COVID-19 pandemic started in China towards the end of 2019 and soon affected the whole world. Restriction and isolation measures have been taken to prevent the spread of this disease caused by a new type of coronavirus, coronavirus-2. These measures have changed people's physical activity levels and have also affected other parameters that physical activity affects. This study aims comparison of clinical parameters in with different physical activity levels during the COVID-19 pandemic period.
Detailed description
In our study, the investigators aimed to compare balance, exercise capacity, sleep quality and coronavirus phobia levels and investigate the relationship between exercise capacity and balance in individuals with different physical activity levels during the COVID-19 pandemic period.
Materials and Methods of the Research:
The place of study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation.
Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.
Research Population, Sample, Research Group:
The population of the study is healthy individuals whose physical activity level was determined according to the results of the International Physical Activity Questionnare (IPAQ).
The sample of the study is healthy individuals whose physical activity level is inactive and minimally/heavily active according to the results of the International Physical Activity Questionnare (IPAQ).
Study Design:
Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65 and whose local language is Turkish. A total of 64 participants, 32 inactive and 32 minimally/heavily active, will be included in the study.
Evaluations will be made using tele-assessment methods, not face-to-face due to the COVID-19 pandemic. Verbal informed consent will be obtained from all subjects by video interview method that they voluntarily participated in the study. Written informed consent will be obtained from the cases whose verbal consent has been obtained.
Inclusion Criteria:
- Being between the ages of 18-65
- Being able to cooperate with the tests
- Not have any known acute or chronic health problems that may prevent them from performing the tests or affect the test performance.
- Not having any known acute or chronic disease that may affect the balance status.
- Not having orthopedic, neurological and serious cardiovascular problems that will affect the performance of the sit-stand test for 1 minute
- Volunteering to participate in the study
- Having access to a phone or video conferencing platform with a reliable internet connection with their own device
- To have the ability to operate these devices independently or with the help of another individual
- Have adequate hearing function and language knowledge
- Be able to move independently and safely even with walking aid
Exclusion Criteria:
- Not cooperating with the tests
- Known information that may prevent it from performing tests or affect test performance have acute and chronic health problems
- Known acute and chronic illness that may affect balance
- Have angina and ischemic heart disease onset at rest or with minimal effort
- Have a cognitive impairment
- Risk of falling and having poor balance Not having access to a phone or video conferencing platform with a reliable internet connection with their own device
- Not having sufficient hearing function and language knowledge
- Not being able to move independently and safely even with walking aid
- Not being willing to participate in the study
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactive | – | –Individuals with physical activity levels of 0-600 METs according to the results of the International Physical Activity Scale (IPAQ). |
| Minimally/Heavily active | – | –Individuals with physical activity levels of 600-3000 METs or 3000 METs and above according to the results of the International Physical Activity Scale (IPAQ). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study is healthy individuals whose physical activity level was determined according to the results of the International Physical Activity Questionnare (IPAQ). The sample of the study is healthy individuals whose physical activity level is inactive and minimally/heavily active according to the results of the International Physical Activity Questionnare (IPAQ).
Key inclusion criteria (10 listed)
- Being between the ages of 18-65
- Being able to cooperate with the tests
- Not have any known acute or chronic health problems that may prevent them from performing the tests or affect the test performance.
- Not having any known acute or chronic disease that may affect the balance status.
- Not having orthopedic, neurological and serious cardiovascular problems that will affect the performance of the sit-stand test for 1 minute
Key exclusion criteria (9 listed)
- Not cooperating with the tests
- Known information that may prevent it from performing tests or affect test performance have acute and chronic health problems
- Known acute and chronic illness that may affect balance
- Have angina and ischemic heart disease onset at rest or with minimal effort
- Have a cognitive impairment
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 Capacity
Time frame: March,2021- August,2021
The 1 minute sit-to-stand test is one of the tests that evaluates exercise capacity.In this test, the number of sitting and standing repetitions in a chair for 1 minute is recorded. Heart rate, shortness of breath, and fatigue perceptions will be recorded before and after the test.
Physical Activity
Time frame: March,2021- August,2021
The International Physical Activity Questionnare (IPAQ)- Short form assesses the level of physical activity.The short form consists of seven questions. It provides information on sitting, walking, moderately vigorous activities, and time spent in vigorous activities.
Cognitive Function
Time frame: March,2021- August,2021
The standardized mini mental test is a test that evaluates the suitability of individuals' cognitive functions for tele-assessment. It consists of eleven items gathered under five main headings: orientation, recording memory, attention and calculation, recall and language.
Coronavirus Phobia
Time frame: March,2021- August,2021
The Coronavirus 19 Phobia Scale (C19P-S) is a scale that evaluates coronavirus phobia. C19P-S is a five-point Likert-type self-assessment scale developed to measure phobia against coronavirus. The test has psychological, somatic, social and economic sub-dimensions.
Sleep Quality
Time frame: March,2021- August,2021
The Pittsburgh Sleep Quality Scale (PSQI) is one of the scales that evaluates sleep quality. PSQI is a self-reported screening and evaluation test that provides information about the type and severity of sleep quality disturbances and sleep structure problems.
Health Literacy
Time frame: March,2021- August,2021
Turkish Health Literacy Scale-32 (TSOY-32) is a scale consisting of 32 questions and evaluating health literacy. The scale, based on the conceptual framework developed by the European Health Literacy Research Consortium, was developed by Okyay et al. to assess health literacy among literate people over the age of 15.
Balance
Time frame: March,2021- August,2021
Berg Balance Scale is a scale used to evaluate dynamic and static balance skills. It consists of 14 activities that require balance skills in different positions such as standing, sitting, and standing on one leg.
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 13 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Physical Activity, run by Hacettepe University 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 10 inclusion and 9 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 13 Aug 2024. 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 Capacity (time frame: March,2021- August,2021). The study lists 7 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 13 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.