Physical Activity LevelNCT04299061
Effect of the Physical Activity Courses on the Physical Activity Level at University Students
A study testing International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index and Physical Activity Awareness Questionnaire - prepared by the researchers in people with Physical Activity Level and Physical Activity Awareness, run by Istanbul Kültür University.
Trial summary
The aim of our study is to evaluate the level of physical activity and awareness of physical activity among university students studying in a department other than health sciences and who have taken courses on "physical activity, exercise, healthy life". Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity Level, Physical Activity Awareness
- What is being tested?
- International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index and Physical Activity Awareness Questionnaire - prepared by the researchers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2020to 30 Jun 2020
- Phase
- Interventional
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer to participate in the study
- Being a student in departments of lawyer, engineering and architecture in university
- Participation in courses is compulsory
- For the study group; having taken physical activity, exercise, wellness classes as compulsory or optional in their university
- For the control group; not taking physical activity, exercise, wellness lessons in their university
Who cannot join
- Being a student in other departments
About this study
Official title: The Effect of the Physical Activity and Healthy Living Elective Courses on Physical Activity Level and Awareness Among University Students Educating in Different Departments
The aim of our study is to evaluate the level of physical activity and awareness of physical activity among university students studying in a department other than health sciences and who have taken courses on "physical activity, exercise, healthy life".
According to the results of the study, the perceptions of students from different departments on physical activity and exercise will be compared and the effects of the courses they have taken on students' attitudes of daily physical activity will be examined.
Read more
Our hypothesizes are:
1 . A course such as an exercise, physical activity or wellness increases the awareness and physical activity level of students studying in different branches.
- Stress and sleep problems are less common among students who do regular physical activity.
- Being tested
- International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index, Physical Activity Awareness Questionnaire - prepared by the researchers, Perceived Stress Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Physical Activity QuestionnaireDiagnostic test
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days)
- Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week
Pittsburgh Sleep Quality IndexDiagnostic test
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.
Physical Activity Awareness Questionnaire - prepared by the researchersOther
It consists of 13 questions to assess the physical activity level awareness of students. The questionnaire was prepared by the researchers therefore it does not have a validation.
Perceived Stress ScaleDiagnostic test
The Perceived Stress Scale (PSS) is a classic stress assessment instrument that helps understand how different situations affect feelings and perceived stress. The questions in this scale ask about feelings and thoughts during the last month. It consists of 14 questions.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Diagnostic Test: International Physical Activity Questionnaire; Diagnostic Test: Pittsburgh Sleep Quality Index; Other: Physical Activity Awareness Questionnaire - prepared by the researchers; Diagnostic Test: Perceived Stress Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days). 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week
Measured: Baseline of the study
Physical Activity Awareness Questionnaire - prepared by the researcher
It consists of 13 questions to assess the physical activity level awareness of students. The questionnaire was prepared by the researchers so it does not have a validation. Questions are about determined the difference between meanings of exercise and physical activity. For example:
Mark it as yes, no or not know.
- Physical activity and exercise mean the same thing.
- Physical activity is a subcategory of exercise.
Measured: Baseline of the study
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. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: Baseline of the study
Perceived Stress Scale
The Perceived Stress Scale (PSS) is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) and summed to create a total score. PSS-14 has strong internal consistency (α = .84 to .86) and good test-retest reliability (r = .85 over a 2-day period, r = .55 over a 6-week period.
Measured: Baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start30 Mar 2020
- Primary completion30 May 2020
- Study completion30 Jun 2020
Why it stopped: Due to the pandemic, sufficient number of participants could not be received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Activity LevelStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Ertürk, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299061
- Sponsor's protocol ID
- FASYD-1
- Status last verified
- Mar 2022
- First submitted
- 5 Mar 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Physical Activity and Healthy Living Elective Courses on Physical Activity Level and Awareness Among University Students Educating in Different Departments
- ClinicalTrials.gov ID
- NCT04299061
- Acronym / sponsor ID
- FASYD-1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the pandemic, sufficient number of participants could not be received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 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 evaluate the level of physical activity and awareness of physical activity among university students studying in a department other than health sciences and who have taken courses on "physical activity, exercise, healthy life".
According to the results of the study, the perceptions of students from different departments on physical activity and exercise will be compared and the effects of the courses they have taken on students' attitudes of daily physical activity will be examined.
Our hypothesizes are:
1 . A course such as an exercise, physical activity or wellness increases the awareness and physical activity level of students studying in different branches.
- Stress and sleep problems are less common among students who do regular physical activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: International Physical Activity Questionnaire, Diagnostic Test: Pittsburgh Sleep Quality Index, Other: Physical Activity Awareness Questionnaire - prepared by the researchers, Diagnostic Test: Perceived Stress Scale |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteer to participate in the study
- Being a student in departments of lawyer, engineering and architecture in university
- Participation in courses is compulsory
- For the study group; having taken physical activity, exercise, wellness classes as compulsory or optional in their university
- For the control group; not taking physical activity, exercise, wellness lessons in their university
Key exclusion criteria (1 listed)
- Being a student in other departments
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 |
|---|---|---|
| International Physical Activity QuestionnaireThis measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days) 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week | Diagnostic test | Study Group |
| Pittsburgh Sleep Quality IndexThe Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper. | Diagnostic test | Study Group |
| Physical Activity Awareness Questionnaire - prepared by the researchersIt consists of 13 questions to assess the physical activity level awareness of students. The questionnaire was prepared by the researchers therefore it does not have a validation. | Other | Study Group |
| Perceived Stress ScaleThe Perceived Stress Scale (PSS) is a classic stress assessment instrument that helps understand how different situations affect feelings and perceived stress. The questions in this scale ask about feelings and thoughts during the last month. It consists of 14 questions. | Diagnostic test | Study Group |
Primary outcome
International Physical Activity Questionnaire
Time frame: Baseline of the study
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days). 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week
Physical Activity Awareness Questionnaire - prepared by the researcher
Time frame: Baseline of the study
It consists of 13 questions to assess the physical activity level awareness of students. The questionnaire was prepared by the researchers so it does not have a validation. Questions are about determined the difference between meanings of exercise and physical activity. For example: Mark it as yes, no or not know. 1. Physical activity and exercise mean the same thing. 2. Physical activity is a subcategory of exercise.
Pittsburgh Sleep Quality Index
Time frame: Baseline of the study
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Perceived Stress Scale
Time frame: Baseline of the study
The Perceived Stress Scale (PSS) is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) and summed to create a total score. PSS-14 has strong internal consistency (α = .84 to .86) and good test-retest reliability (r = .85 over a 2-day period, r = .55 over a 6-week period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index and Physical Activity Awareness Questionnaire - prepared by the researchers in people with Physical Activity Level and Physical Activity Awareness, run by Istanbul Kültür University.
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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
International Physical Activity Questionnaire (time frame: Baseline of the study). The study lists 4 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 2022.