<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/NCT04443374</url>
  </required_header>
  <id_info>
    <org_study_id>24</org_study_id>
    <nct_id>NCT04443374</nct_id>
  </id_info>
  <brief_title>The Turkish Version of the Simple Physical Activity Questionnaire (SIMPAQ)</brief_title>
  <acronym>SIMPAQ</acronym>
  <official_title>The Reliability and Validity of the Turkish Version of the Simple Physical Activity Questionnaire (SIMPAQ)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University - Cerrahpasa (IUC)</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>
      The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to&#xD;
      assess physical activity level particularly people with mental illnesses. The purpose of this&#xD;
      study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its&#xD;
      psychometric properties.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to&#xD;
      assess physical activity level particularly people with mental illnesses. The purpose of this&#xD;
      study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its&#xD;
      psychometric properties. Eighty individuals with mental illnesses (major depression, bipolar&#xD;
      disorder, anxiety disorder, schizophrenia, alcohol and substance addiction) will include. For&#xD;
      cross-cultural adaptation and validation procedure, developers' manual in the official site&#xD;
      will be followed (http://www.simpaq.org/). Within a 5-to-7-day period after the first&#xD;
      assessment, the participants completed the Turkish version of the SIMPAQ to evaluate&#xD;
      test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The&#xD;
      correlations with the Turkish version of the International Physical Activity-Short Form&#xD;
      (IPAQ-SF) and Brief Psychiatric Rating Scale (BPRS) and Turkish version of the DSM-5&#xD;
      Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version (DSM XC) will determine to check&#xD;
      the validity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">August 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Simple Physical Activity Questionnaire</measure>
    <time_frame>Baseline (First assessment)</time_frame>
    <description>The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Simple Physical Activity Questionnaire</measure>
    <time_frame>Within a 5-to-7-day period after the first assessment (Second assessment)</time_frame>
    <description>The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire-Short Form</measure>
    <time_frame>Baseline (First assessment)</time_frame>
    <description>International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a self-report questionnaire that assesses PA in the last 7 days. IPAQ-SF provides information on walking, moderate and vigorous activities and time spent sitting, within a week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Psychiatric Rating Scale</measure>
    <time_frame>Baseline (First assessment)</time_frame>
    <description>Brief Psychiatric Rating Scale (BPRS) is a valid 18-item quantitative scale for assessing psychopathology and its severity. Each item is measured on a five-point scale (0 = none to 4 = very severe), with lower scores meaning a lower severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult</measure>
    <time_frame>Baseline (First assessment)</time_frame>
    <description>DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult (DSM XC) comprises 23 self-rated symptoms that capture 13 mental health domains. Respondents indicate how much (or how often) they have been bothered by each symptom in the prior two weeks using a five-point response scale (none, not at all to severe, nearly every day). A score of 2 or higher in most domains, except substance use (score of 1 or higher) is suggestive of clinically-relevant mental health problems.</description>
  </secondary_outcome>
  <enrollment type="Actual">81</enrollment>
  <condition>Psychiatric Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include 80 patients diagnosed with major depression, bipolar disorder,&#xD;
        anxiety disorder, schizophrenia, alcohol and substance addiction by the psychiatrists in&#xD;
        Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research&#xD;
        Hospital, University of Health Sciences. The individuals who volunteers and meets the&#xD;
        inclusion criteria will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aged between 18 and 60 years Being a volunteer to participate Being an outpatient or&#xD;
        inpatient at the place of the study Being diagnosed with major depression, bipolar&#xD;
        disorder, anxiety disorder, schizophrenia, alcohol and substance addiction according to&#xD;
        DSM-5 or ICD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Having cognitive impairment Having disabilities in understanding, speaking and reading&#xD;
        Turkish Having vision and / or hearing problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebru KAYA MUTLU, PT, PhD</last_name>
    <role>Study Director</role>
    <affiliation>İstanbul University-Cerrahpaşa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>İstanbul University-Cerrahpaşa</name>
      <address>
        <city>Istanbul</city>
        <zip>34500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>August 20, 2020</last_update_submitted>
  <last_update_submitted_qc>August 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
    <investigator_full_name>Aybike Senel</investigator_full_name>
    <investigator_title>PT,MSc, Research Assistant</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>measurement</keyword>
  <keyword>assessment</keyword>
  <keyword>sedentary behaviour</keyword>
  <keyword>mental illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</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/NCT04443374
org study id: 24
nct id: NCT04443374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to
      assess physical activity level particularly people with mental illnesses. The purpose of this
      study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its
      psychometric properties.
The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to
      assess physical activity level particularly people with mental illnesses. The purpose of this
      study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its
      psychometric properties. Eighty individuals with mental illnesses (major depression, bipolar
      disorder, anxiety disorder, schizophrenia, alcohol and substance addiction) will include. For
      cross-cultural adaptation and validation procedure, developers' manual in the official site
      will be followed (http://www.simpaq.org/). Within a 5-to-7-day period after the first
      assessment, the participants completed the Turkish version of the SIMPAQ to evaluate
      test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The
      correlations with the Turkish version of the International Physical Activity-Short Form
      (IPAQ-SF) and Brief Psychiatric Rating Scale (BPRS) and Turkish version of the DSM-5
      Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version (DSM XC) will determine to check
      the validity.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Simple Physical Activity Questionnaire
time frame: Baseline (First assessment)
description: The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week).
measure: Simple Physical Activity Questionnaire
time frame: Within a 5-to-7-day period after the first assessment (Second assessment)
description: The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week).
measure: International Physical Activity Questionnaire-Short Form
time frame: Baseline (First assessment)
description: International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a self-report questionnaire that assesses PA in the last 7 days. IPAQ-SF provides information on walking, moderate and vigorous activities and time spent sitting, within a week.
measure: Brief Psychiatric Rating Scale
time frame: Baseline (First assessment)
description: Brief Psychiatric Rating Scale (BPRS) is a valid 18-item quantitative scale for assessing psychopathology and its severity. Each item is measured on a five-point scale (0 = none to 4 = very severe), with lower scores meaning a lower severity of the symptom.
measure: DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult
time frame: Baseline (First assessment)
description: DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult (DSM XC) comprises 23 self-rated symptoms that capture 13 mental health domains. Respondents indicate how much (or how often) they have been bothered by each symptom in the prior two weeks using a five-point response scale (none, not at all to severe, nearly every day). A score of 2 or higher in most domains, except substance use (score of 1 or higher) is suggestive of clinically-relevant mental health problems.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ebru KAYA MUTLU, PT, PhD
role: Study Director
affiliation: İstanbul University-Cerrahpaşa
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University - Cerrahpasa (IUC)
investigator full name: Aybike Senel
investigator title: PT,MSc, Research Assistant
mesh term: Mental Disorders
mesh term: Problem Behavior