Physical ActivityNCT03841461
Investigation of the Effect of Physical Activity Level on Sleep Quality and Fatigue in Academicians
An observational study of Physical Activity and Sleep, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Physical activity is closely associated with well-being condition and health development. The sleep quality and fatigue levels of individuals are also important components of health. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sleep, Fatigue
- What is being tested?
- International Physical Activity Questionnaire-Short Form, The Pittsburgh Sleep Quality Index and The Fatigue Severity Scale
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2019to 31 Mar 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The academicians working in any department of any higher education institution.
Who may be able to join
- Volunteering, to work as academicians in any department of any higher education institution.
Who cannot join
- refuse to participate in the study, not being an academician
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Province, 06270
Ankara Yıldırım Beyazıt University
About this study
Physical activity is closely associated with well-being condition and health development. The sleep quality and fatigue levels of individuals are also important components of health. Within the scope of our study, it is aimed to investigate the physical activity levels, sleep quality and fatigue levels of the academicians, who are generally working on a desk and we think that they live a sedentary life. Within the scope of this study, academicians were asked to respond to , International Physical Activity Questionnaire-Short Form (IPAQ-Short Form), general evaluation form, Pittsburg Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS) .
Read the detailed description
The aim of this study is to investigate that the effect of physical activity level on sleep quality and fatigue in academicians.
First of all, a form including the purpose of the study, demographic information, daily working hours and assignment durations, was arranged; then obtaining general information about academicians who participated in the study and the physical activity levels of the individuals with International Physical Activity Questionnaire-Short Form (IPAQ-Short Form); sleep quality with the Pittsburg Sleep Quality Index (PSQI); fatigue levels with Fatigue Severity Scale (FSS) were planned to be measured. On-line communication was preferred as a data collection tool for all these assessments. In order to prevent bias in the results of the study, it was planned to transmit the questionnaire on-line to the academicians working in any program of any higher education institution. In this way, the voluntary involvement of the participant or any other threat to abuse was prevented. In other words, it was planned to ensure that individuals answer or don't respond the form on a purely voluntary basis.
- Conditions
- Physical Activity, Sleep, Fatigue
- Being tested
- International Physical Activity Questionnaire-Short Form, The Pittsburgh Sleep Quality Index, The Fatigue Severity Scale, General Information Form
- Keywords
- Academician, Physical Activity Level, Sleep Quality, Fatigue
- Medical subject headings
- Motor Activity, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Physical Activity Questionnaire-Short FormOther
Also called IPAQ-SF
IPAQ has been developed to obtain valid and comparable information about the level of physical activity based on individual reports on daily physical activity in the international arena. This form consists of 7 questions; provides information about time spent in walking, moderate and violent activities, and time spent sitting. The calculation of the total score of the short form includes total of duration and frequency whom walking, moderate activity and severe activity. The energy required for the activities is calculated by the MET-minute score.Standard MET values for these activities has been established. These; Walking = 3.3 MET;Moderate Severe Physical Activity = 4.0 MET;Severe Physical Activity = 8.0 MET;Seating = 1.5 MET.Classification is based on the numerical data obtained.Accordingly,there are 3 activity levels: Inactive,minimal active and very active.
The Pittsburgh Sleep Quality IndexOther
Also called PSQI
It is a scale that provides information about the sleep quality of the individuals and the type and severity of the sleep disorder in the last month. It consists of 24 questions, 19 of which are evaluated. The PSQI consists of 1 total score and 7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, sleep medication use, daytime dysfunction). Each item in the scale has a value between 0 (no distress) and 3 (serious distress). The sum of the scores related to the seven sub-dimensions gives the total PSQI score. The score of each sub-dimension ranges from 0 to 3. The total PSQI score ranged from 0 to 21. While the sleep quality of the patients with a total score of 5 and below is considered as 'good'; >5 refers to poor sleep quality.
The Fatigue Severity ScaleOther
Also called FSS
Each question on this scale, which is composed of Likert type questions: 1.I strongly disagree 2.I do not agree 3.No tend to disagree 4. Indefinitely. The score of the scale, which consists of 9 questions, varies between 9-63. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period.
General Information FormOther
A form, which is prepared by us, including the purpose of the study, demographic information, daily working hours and assignment durations.
| Study group | Role | What they receive |
|---|---|---|
| Academicians | The academicians working in any program of any higher education institution Receives: Other: International Physical Activity Questionnaire-Short Form; Other: The Pittsburgh Sleep Quality Index; Other: The Fatigue Severity Scale; Other: General Information Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of physical activity
International Physical Activity Questionnaire-Short Form (IPAQ-SF) consists of 7 questions;provides information about the level of physical activity in the last 7days.The calculation of the total score of the form includes total of duration and frequency whom walking,moderate activity and severe activity.The MET-minute scores;Walking 3.3MET,Moderate Severe Physical Activity 4MET,Severe Physical Activity 8MET,Seating 1.5MET.Classification is based on the numerical data obtained.Accordingly,there are 3 activity levels: Inactive,minimal active and very active.The lowest level of physical activity is inactive and the highest level of physical activity is very active.
Measured: 1 month
Secondary outcomes (2)
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a scale that provides information about the sleep quality of the individuals and the type and severity of the sleep disorder in the last month. It consists of 24 questions, 19 of which are evaluated. The PSQI consists of 1 total score and 7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, sleep medication use, daytime dysfunction). Each item in the scale has a value between 0 (no distress) and 3 (serious distress). The sum of the scores related to the seven sub-dimensions gives the total PSQI score. The score of each subdimension ranges from 0 to 3. The total PSQI score ranged from 0 to 21. While the sleep quality of the patients with a total score of 5 and below is considered as 'good'; >5 refers to poor sleep quality.
Measured: 1 month
Fatigue Level
Fatigue Severity Scale (FSS) is one of the most commonly used self-report questionnaires to measure fatigue. Each question on this scale, which is composed of Likert type questions: 1.I strongly disagree 2.I do not agree 3.No tend to disagree 4. Indefinitely. The total score of the scale, which consists of 9 questions, varies between 9-63. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start8 Feb 2019
- Primary completion1 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
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 Ankara Yildirim Beyazıt 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazire Nur Yıldız, PT, Principal investigator, AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree StudentErtuğrul Demirdel, Asst. Prof., Principal investigator, AYBU Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841461
- Sponsor's protocol ID
- 284
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 19 Feb 2019
- 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 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Physical Activity Level on Sleep Quality and Fatigue in Academicians
- ClinicalTrials.gov ID
- NCT03841461
- Acronym / sponsor ID
- 284
- Conditions
- Physical Activity, Sleep, Fatigue
- Keywords
- Academician, Physical Activity Level, Sleep Quality, Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 15 Feb 2019 (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.
Physical activity is closely associated with well-being condition and health development. The sleep quality and fatigue levels of individuals are also important components of health. Within the scope of our study, it is aimed to investigate the physical activity levels, sleep quality and fatigue levels of the academicians, who are generally working on a desk and we think that they live a sedentary life. Within the scope of this study, academicians were asked to respond to , International Physical Activity Questionnaire-Short Form (IPAQ-Short Form), general evaluation form, Pittsburg Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS) .
Detailed description
The aim of this study is to investigate that the effect of physical activity level on sleep quality and fatigue in academicians.
First of all, a form including the purpose of the study, demographic information, daily working hours and assignment durations, was arranged; then obtaining general information about academicians who participated in the study and the physical activity levels of the individuals with International Physical Activity Questionnaire-Short Form (IPAQ-Short Form); sleep quality with the Pittsburg Sleep Quality Index (PSQI); fatigue levels with Fatigue Severity Scale (FSS) were planned to be measured. On-line communication was preferred as a data collection tool for all these assessments. In order to prevent bias in the results of the study, it was planned to transmit the questionnaire on-line to the academicians working in any program of any higher education institution. In this way, the voluntary involvement of the participant or any other threat to abuse was prevented. In other words, it was planned to ensure that individuals answer or don't respond the form on a purely voluntary basis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Academicians | – | Other: International Physical Activity Questionnaire-Short Form, Other: The Pittsburgh Sleep Quality Index, Other: The Fatigue Severity Scale, Other: General Information FormThe academicians working in any program of any higher education institution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The academicians working in any department of any higher education institution.
Key inclusion criteria (1 listed)
- Volunteering, to work as academicians in any department of any higher education institution.
Key exclusion criteria (1 listed)
- refuse to participate in the study, not being an academician
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 Questionnaire-Short FormAlso: IPAQ-SFIPAQ has been developed to obtain valid and comparable information about the level of physical activity based on individual reports on daily physical activity in the international arena. This form consists of 7 questions; provides information about time spent in walking, moderate and violent activities, and time spent sitting. The calculation of the total score of the short form includes total of duration and frequency whom walking, moderate activity and severe activity. The energy required for the activities is calculated by the MET-minute score.Standard MET values for these activities has been established. These; Walking = 3.3 MET;Moderate Severe Physical Activity = 4.0 MET;Severe Physical Activity = 8.0 MET;Seating = 1.5 MET.Classification is based on the numerical data obtained.Accordingly,there are 3 activity levels: Inactive,minimal active and very active. | Other | Academicians |
| The Pittsburgh Sleep Quality IndexAlso: PSQIIt is a scale that provides information about the sleep quality of the individuals and the type and severity of the sleep disorder in the last month. It consists of 24 questions, 19 of which are evaluated. The PSQI consists of 1 total score and 7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, sleep medication use, daytime dysfunction). Each item in the scale has a value between 0 (no distress) and 3 (serious distress). The sum of the scores related to the seven sub-dimensions gives the total PSQI score. The score of each sub-dimension ranges from 0 to 3. The total PSQI score ranged from 0 to 21. While the sleep quality of the patients with a total score of 5 and below is considered as 'good'; >5 refers to poor sleep quality. | Other | Academicians |
| The Fatigue Severity ScaleAlso: FSSEach question on this scale, which is composed of Likert type questions: 1.I strongly disagree 2.I do not agree 3.No tend to disagree 4. Indefinitely. The score of the scale, which consists of 9 questions, varies between 9-63. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. | Other | Academicians |
| General Information FormA form, which is prepared by us, including the purpose of the study, demographic information, daily working hours and assignment durations. | Other | Academicians |
Primary outcome
The level of physical activity
Time frame: 1 month
International Physical Activity Questionnaire-Short Form (IPAQ-SF) consists of 7 questions;provides information about the level of physical activity in the last 7days.The calculation of the total score of the form includes total of duration and frequency whom walking,moderate activity and severe activity.The MET-minute scores;Walking 3.3MET,Moderate Severe Physical Activity 4MET,Severe Physical Activity 8MET,Seating 1.5MET.Classification is based on the numerical data obtained.Accordingly,there are 3 activity levels: Inactive,minimal active and very active.The lowest level of physical activity is inactive and the highest level of physical activity is very active.
2 secondary outcomes
Sleep Quality
Time frame: 1 month
Fatigue Level
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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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.
Nazire Nur Yıldız, PT principal investigator
AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree Student
Ertuğrul Demirdel, Asst. Prof. principal investigator
AYBU Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
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 and Sleep, run by Ankara Yildirim Beyazıt 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 1 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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. 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 Nazire Nur Yıldız, PT (+905444184376, nnur_yildiz_58@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of physical activity (time frame: 1 month). 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 19 Feb 2019.