<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03841461</url>
  </required_header>
  <id_info>
    <org_study_id>284</org_study_id>
    <nct_id>NCT03841461</nct_id>
  </id_info>
  <brief_title>Investigation of the Effect of Physical Activity Level on Sleep Quality and Fatigue in Academicians</brief_title>
  <official_title>Investigation of the Effect of Physical Activity Level on Sleep Quality and Fatigue in Academicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Yildirim Beyazıt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Yildirim Beyazıt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical activity is closely associated with well-being condition and health development. The&#xD;
      sleep quality and fatigue levels of individuals are also important components of health.&#xD;
      Within the scope of our study, it is aimed to investigate the physical activity levels, sleep&#xD;
      quality and fatigue levels of the academicians, who are generally working on a desk and we&#xD;
      think that they live a sedentary life. Within the scope of this study, academicians were&#xD;
      asked to respond to , International Physical Activity Questionnaire-Short Form (IPAQ-Short&#xD;
      Form), general evaluation form, Pittsburg Sleep Quality Index (PSQI) and Fatigue Severity&#xD;
      Scale (FSS) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate that the effect of physical activity level on sleep&#xD;
      quality and fatigue in academicians.&#xD;
&#xD;
      First of all, a form including the purpose of the study, demographic information, daily&#xD;
      working hours and assignment durations, was arranged; then obtaining general information&#xD;
      about academicians who participated in the study and the physical activity levels of the&#xD;
      individuals with International Physical Activity Questionnaire-Short Form (IPAQ-Short Form);&#xD;
      sleep quality with the Pittsburg Sleep Quality Index (PSQI); fatigue levels with Fatigue&#xD;
      Severity Scale (FSS) were planned to be measured. On-line communication was preferred as a&#xD;
      data collection tool for all these assessments. In order to prevent bias in the results of&#xD;
      the study, it was planned to transmit the questionnaire on-line to the academicians working&#xD;
      in any program of any higher education institution. In this way, the voluntary involvement of&#xD;
      the participant or any other threat to abuse was prevented. In other words, it was planned to&#xD;
      ensure that individuals answer or don't respond the form on a purely voluntary basis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The level of physical activity</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>1 month</time_frame>
    <description>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'; &gt;5 refers to poor sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Level</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Physical Activity</condition>
  <condition>Sleep</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Academicians</arm_group_label>
    <description>The academicians working in any program of any higher education institution</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>International Physical Activity Questionnaire-Short Form</intervention_name>
    <description>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.</description>
    <arm_group_label>Academicians</arm_group_label>
    <other_name>IPAQ-SF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Pittsburgh Sleep Quality Index</intervention_name>
    <description>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'; &gt;5 refers to poor sleep quality.</description>
    <arm_group_label>Academicians</arm_group_label>
    <other_name>PSQI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Fatigue Severity Scale</intervention_name>
    <description>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.</description>
    <arm_group_label>Academicians</arm_group_label>
    <other_name>FSS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General Information Form</intervention_name>
    <description>A form, which is prepared by us, including the purpose of the study, demographic information, daily working hours and assignment durations.</description>
    <arm_group_label>Academicians</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The academicians working in any department of any higher education institution.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Volunteering, to work as academicians in any department of any higher education&#xD;
        institution.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        refuse to participate in the study, not being an academician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nazire Nur Yıldız, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree Student</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ertuğrul Demirdel, Asst. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>AYBU Faculty of Health Sciences Department of Physiotherapy and Rehabilitation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nazire Nur Yıldız, PT</last_name>
    <phone>+905444184376</phone>
    <email>nnur_yildiz_58@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ertuğrul Demirdel, Asst. Prof.</last_name>
    <phone>+905378223551</phone>
    <email>ertudemirdel@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <state>Province</state>
        <zip>06270</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ankara Yıldırım Beyazıt University</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 17, 2019</last_update_submitted>
  <last_update_submitted_qc>February 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Academician</keyword>
  <keyword>Physical Activity Level</keyword>
  <keyword>Sleep Quality</keyword>
  <keyword>Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03841461
org study id: 284
nct id: NCT03841461
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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) .
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.
observational model: Other
time perspective: Cross-Sectional
measure: The level of physical activity
time frame: 1 month
description: 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.
measure: Sleep Quality
time frame: 1 month
description: 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.
measure: Fatigue Level
time frame: 1 month
description: 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.
arm group label: Academicians
description: The academicians working in any program of any higher education institution
intervention type: Other
intervention name: International Physical Activity Questionnaire-Short Form
description: 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.
arm group label: Academicians
other name: IPAQ-SF
intervention type: Other
intervention name: The Pittsburgh Sleep Quality Index
description: 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.
arm group label: Academicians
other name: PSQI
intervention type: Other
intervention name: The Fatigue Severity Scale
description: 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.
arm group label: Academicians
other name: FSS
intervention type: Other
intervention name: General Information Form
description: A form, which is prepared by us, including the purpose of the study, demographic information, daily working hours and assignment durations.
arm group label: Academicians
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nazire Nur Yıldız, PT
role: Principal Investigator
affiliation: AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree Student
last name: Ertuğrul Demirdel, Asst. Prof.
role: Principal Investigator
affiliation: AYBU Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
last name: Nazire Nur Yıldız, PT
phone: +905444184376
email: nnur_yildiz_58@hotmail.com
last name: Ertuğrul Demirdel, Asst. Prof.
phone: +905378223551
email: ertudemirdel@yahoo.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Sponsor
mesh term: Fatigue