<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/NCT03813420</url>
  </required_header>
  <id_info>
    <org_study_id>ISU</org_study_id>
    <nct_id>NCT03813420</nct_id>
  </id_info>
  <brief_title>Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level</brief_title>
  <acronym>SleepQuality</acronym>
  <official_title>Sleep Quality Among Physiotherapy Students and Its Relation to Quality of Life and Physical Activity Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istinye University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istinye University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      There is a high prevalence of poor sleep quality among university students studying in&#xD;
      different areas such as medicine, nursing, art, science, social work etc. and in different&#xD;
      countries. However, the studies done especially for physiotherapy students, and in Turkey, as&#xD;
      well, are not many. Therefore, we aimed to search the sleep quality among physiotherapy&#xD;
      students, and observe the association between the health related quality of life and physical&#xD;
      activity level of the physiotherapy students.&#xD;
&#xD;
      The physiotherapy students were included. Their quality of sleep will be assessed by&#xD;
      Pittsburgh Sleep Quality Index. The physical activity will be searched by International&#xD;
      Physical Activity Questionnaire, and SF-36 will be used to assess quality of life. Data is&#xD;
      going to analyzed statistically&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therefore, recent studies are focusing on the sleep quality of university students in&#xD;
      different countries, and reporting that medical students pharmacy students, nursing students&#xD;
      are experiencing poor quality of sleep. However, to our knowledge, studies done on sleep&#xD;
      quality of students and especially the physiotherapy students are not available in Turkey,&#xD;
      yet.&#xD;
&#xD;
      Hence, since the university students are one of the high risk groups for developing poor&#xD;
      sleep quality, we aimed to evaluate if the sleep quality of the physiotherapy students in&#xD;
      both gender are associated with their quality of life and physical activity level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2018</start_date>
  <completion_date type="Actual">September 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>3 months</time_frame>
    <description>The sleep quality of the students will be evaluated by means of the Turkish version of the Pittsburgh Sleep Quality Index through face-to-face interview. This assessment will provide us information about the type and duration of their sleep as well as their sleep efficiency, if there are any sleep disturbances or if they are using any sleep medications or not. Additionally, this will provide us about if the sleep quality affects their daytime functions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>The physical activity of the participants will assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form. The frequency (days per week) and duration (hours) of walking, the intensity of their physical activity as if they are low, moderately and vigorously physical active or not will be searched. This covers the duration of the last seven days prior to survey.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health related quality-of -life</measure>
    <time_frame>3 months</time_frame>
    <description>The Turkish version of SF-36 will used to understand the health related quality-of -life of the participants over the past four weeks. The eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions will be searched. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Sleep Quality</condition>
  <condition>Quality of Life</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Physiotherapy students</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Pittsburgh Sleep Quality Index-PSQI:The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month&#xD;
International Physical Activity Questionnaire-IPAQ: The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as the intensity of physical activity in the last seven days.&#xD;
Short Form-36-SF-36: The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pittsburgh Sleep Quality Index (PSQI)</intervention_name>
    <description>The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month. It has seven components as subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.&#xD;
Each component is scored from 0 to 3, and the Global Pittsburgh Quality of Sleep (PQS) score is the sum of the scores of the seven components that is between 0 and 21. The higher Global PQS scores indicate poor sleep quality and the cut off score for poor sleep is 5 and over.</description>
    <arm_group_label>Physiotherapy students</arm_group_label>
    <other_name>IPAQ, SF-36 Quality of life</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>International Physical Activity Questionnaire (IPAQ)</intervention_name>
    <description>The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as low, moderate and vigorous physical activity that they engaged in during the last seven days prior to survey. Vigorous physical activity, defined by the questionnaire, referred to intense exercise that resulted in very rapid breathing and an elevated heart rate (e.g. intense weight lifting, aerobics, running, and cycling). Moderate physical activity was defined as less intense exercise that slightly heightened breathing and heart rate (e.g. less exertive cycling, fast walking, and light weight lifting).</description>
    <arm_group_label>Physiotherapy students</arm_group_label>
    <other_name>Pittsburgh Sleep Quality Index, SF-36</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Short Form 36 Health Survey (SF-36)</intervention_name>
    <description>The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Additionally, the psychometric evaluation of the SF-36 generated two summary scores as the Mental Health Component Score and the Physical Health Component Score that the higher scores indicate better HRQOL.</description>
    <arm_group_label>Physiotherapy students</arm_group_label>
    <other_name>IPAQ, Pittsburgh Sleep Quality Index</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being physiotherapy and rehabilitation students&#xD;
&#xD;
          -  Being the age between 18-26 years old&#xD;
&#xD;
          -  Being voluntary to participate to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not having any systemic disease&#xD;
&#xD;
          -  Any expressed psychological condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ekin Aktay Karlik, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University</name>
      <address>
        <city>Istanbul</city>
        <zip>34010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Manzar MD, Zannat W, Hussain ME, Pandi-Perumal SR, Bahammam AS, Barakat D, Ojike NI, Olaish A, Spence DW. Dimensionality of the Pittsburgh Sleep Quality Index in the collegiate young adults. Springerplus. 2016 Sep 13;5(1):1550. doi: 10.1186/s40064-016-3234-x. eCollection 2016.</citation>
    <PMID>27652123</PMID>
  </reference>
  <results_reference>
    <citation>Almojali AI, Almalki SA, Alothman AS, Masuadi EM, Alaqeel MK. The prevalence and association of stress with sleep quality among medical students. J Epidemiol Glob Health. 2017 Sep;7(3):169-174. doi: 10.1016/j.jegh.2017.04.005. Epub 2017 May 5.</citation>
    <PMID>28756825</PMID>
  </results_reference>
  <results_reference>
    <citation>Chang SP, Shih KS, Chi CP, Chang CM, Hwang KL, Chen YH. Association Between Exercise Participation and Quality of Sleep and Life Among University Students in Taiwan. Asia Pac J Public Health. 2016 May;28(4):356-67. doi: 10.1177/1010539516645160. Epub 2016 Apr 28.</citation>
    <PMID>27130632</PMID>
  </results_reference>
  <results_reference>
    <citation>Elagra MI, Rayyan MR, Alnemer OA, Alshehri MS, Alsaffar NS, Al-Habib RS, Almosajen ZA. Sleep quality among dental students and its association with academic performance. J Int Soc Prev Community Dent. 2016 Jul-Aug;6(4):296-301. doi: 10.4103/2231-0762.186788.</citation>
    <PMID>27583216</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>May 13, 2022</last_update_submitted>
  <last_update_submitted_qc>May 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istinye University</investigator_affiliation>
    <investigator_full_name>Habibe Serap Inal</investigator_full_name>
    <investigator_title>Prof.Dr.</investigator_title>
  </responsible_party>
  <keyword>Sleep quality</keyword>
  <keyword>Body mass index</keyword>
  <keyword>Active life</keyword>
  <keyword>Academic performance</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03813420
org study id: ISU
nct id: NCT03813420
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a high prevalence of poor sleep quality among university students studying in
      different areas such as medicine, nursing, art, science, social work etc. and in different
      countries. However, the studies done especially for physiotherapy students, and in Turkey, as
      well, are not many. Therefore, we aimed to search the sleep quality among physiotherapy
      students, and observe the association between the health related quality of life and physical
      activity level of the physiotherapy students.

      The physiotherapy students were included. Their quality of sleep will be assessed by
      Pittsburgh Sleep Quality Index. The physical activity will be searched by International
      Physical Activity Questionnaire, and SF-36 will be used to assess quality of life. Data is
      going to analyzed statistically
Therefore, recent studies are focusing on the sleep quality of university students in
      different countries, and reporting that medical students pharmacy students, nursing students
      are experiencing poor quality of sleep. However, to our knowledge, studies done on sleep
      quality of students and especially the physiotherapy students are not available in Turkey,
      yet.

      Hence, since the university students are one of the high risk groups for developing poor
      sleep quality, we aimed to evaluate if the sleep quality of the physiotherapy students in
      both gender are associated with their quality of life and physical activity level.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Sleep Quality
time frame: 3 months
description: The sleep quality of the students will be evaluated by means of the Turkish version of the Pittsburgh Sleep Quality Index through face-to-face interview. This assessment will provide us information about the type and duration of their sleep as well as their sleep efficiency, if there are any sleep disturbances or if they are using any sleep medications or not. Additionally, this will provide us about if the sleep quality affects their daytime functions.
measure: Physical activity
time frame: 3 months
description: The physical activity of the participants will assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form. The frequency (days per week) and duration (hours) of walking, the intensity of their physical activity as if they are low, moderately and vigorously physical active or not will be searched. This covers the duration of the last seven days prior to survey.
measure: Health related quality-of -life
time frame: 3 months
description: The Turkish version of SF-36 will used to understand the health related quality-of -life of the participants over the past four weeks. The eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions will be searched. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
arm group label: Physiotherapy students
arm group type: Other
description: Pittsburgh Sleep Quality Index-PSQI:The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month
International Physical Activity Questionnaire-IPAQ: The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as the intensity of physical activity in the last seven days.
Short Form-36-SF-36: The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts.
intervention type: Behavioral
intervention name: Pittsburgh Sleep Quality Index (PSQI)
description: The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month. It has seven components as subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.
Each component is scored from 0 to 3, and the Global Pittsburgh Quality of Sleep (PQS) score is the sum of the scores of the seven components that is between 0 and 21. The higher Global PQS scores indicate poor sleep quality and the cut off score for poor sleep is 5 and over.
arm group label: Physiotherapy students
other name: IPAQ, SF-36 Quality of life
intervention type: Behavioral
intervention name: International Physical Activity Questionnaire (IPAQ)
description: The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as low, moderate and vigorous physical activity that they engaged in during the last seven days prior to survey. Vigorous physical activity, defined by the questionnaire, referred to intense exercise that resulted in very rapid breathing and an elevated heart rate (e.g. intense weight lifting, aerobics, running, and cycling). Moderate physical activity was defined as less intense exercise that slightly heightened breathing and heart rate (e.g. less exertive cycling, fast walking, and light weight lifting).
arm group label: Physiotherapy students
other name: Pittsburgh Sleep Quality Index, SF-36
intervention type: Behavioral
intervention name: The Short Form 36 Health Survey (SF-36)
description: The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Additionally, the psychometric evaluation of the SF-36 generated two summary scores as the Mental Health Component Score and the Physical Health Component Score that the higher scores indicate better HRQOL.
arm group label: Physiotherapy students
other name: IPAQ, Pittsburgh Sleep Quality Index
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ekin Aktay Karlik, MSc
role: Study Chair
affiliation: Istanbul University
facility: 
country: Turkey
citation: Manzar MD, Zannat W, Hussain ME, Pandi-Perumal SR, Bahammam AS, Barakat D, Ojike NI, Olaish A, Spence DW. Dimensionality of the Pittsburgh Sleep Quality Index in the collegiate young adults. Springerplus. 2016 Sep 13;5(1):1550. doi: 10.1186/s40064-016-3234-x. eCollection 2016.
PMID: 27652123
citation: Almojali AI, Almalki SA, Alothman AS, Masuadi EM, Alaqeel MK. The prevalence and association of stress with sleep quality among medical students. J Epidemiol Glob Health. 2017 Sep;7(3):169-174. doi: 10.1016/j.jegh.2017.04.005. Epub 2017 May 5.
PMID: 28756825
citation: Chang SP, Shih KS, Chi CP, Chang CM, Hwang KL, Chen YH. Association Between Exercise Participation and Quality of Sleep and Life Among University Students in Taiwan. Asia Pac J Public Health. 2016 May;28(4):356-67. doi: 10.1177/1010539516645160. Epub 2016 Apr 28.
PMID: 27130632
citation: Elagra MI, Rayyan MR, Alnemer OA, Alshehri MS, Alsaffar NS, Al-Habib RS, Almosajen ZA. Sleep quality among dental students and its association with academic performance. J Int Soc Prev Community Dent. 2016 Jul-Aug;6(4):296-301. doi: 10.4103/2231-0762.186788.
PMID: 27583216
responsible party type: Principal Investigator
investigator affiliation: Istinye University
investigator full name: Habibe Serap Inal
investigator title: Prof.Dr.
sharing ipd: No