<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/NCT04412278</url>
  </required_header>
  <id_info>
    <org_study_id>500600127</org_study_id>
    <nct_id>NCT04412278</nct_id>
  </id_info>
  <brief_title>Impact of COVID-19 Pandemic on Perceived Exercise Benefits and Barriers</brief_title>
  <official_title>Impact of COVID-19 Pandemic on Perceived Exercise Benefits and Barriers: Cross Sectional Study on Turkish Society and Interpretation With Physical Activity Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Okan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Okan 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>
      It is aimed to determine the physical activity level and exercise benefits and barriers&#xD;
      caused by Covid-19 pandemic and reveal the relationship between them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study hypothesis that people are tend to be physically inactive while Covid-19 pandemic. It&#xD;
      is aimed to determine the exercise benefits and barriers caused by Covid-19 pandemic and&#xD;
      reveal the relationship among gender, age, marial status and physical activity level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 8, 2020</completion_date>
  <primary_completion_date type="Actual">June 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise Benefits and Barriers Scale</measure>
    <time_frame>three months after Covid 19 recognised as pandemic</time_frame>
    <description>The Exercise Benefits/Barriers Scale (EBBS) was developed in response to a need for an instrument to determine perceptions of individuals concerning the benefits of and barriers to participating in exercise. The instrument may be scored and used in its entirety or as two separate scales. The instrument has a four-response, forced-choice Likert-type format with responses ranging from 4 (strongly agree) to 1 (strongly disagree). Scores on the total instrument can range from 43 to 172. The higher the score, the more positively the individual perceives exercise. When the Benefits Scale is used alone, the score range is between 29 and 116. When the Barriers Scale is used alone, scores range between 14 and 56. If used alone, the Barriers Scale does not need to be reverse-scored. In this instance, the higher the score on the Barriers Scale, the greater the perception of barriers to exercise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sociodemographic information</measure>
    <time_frame>three months after Covid 19 recognised as pandemic</time_frame>
    <description>Participants will be asked to give information about: age, gender, educational status, height, weight, occupation, working status, whether they have a chronic disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionairre</measure>
    <time_frame>three months after Covid 19 recognised as pandemic</time_frame>
    <description>The IPAQ-S developed for participants to report activities performed for at least 10 minutes during the last 7 days. Respondents will be asked to report time spent in physical activity performed across leisure time, work, domestic activities, and transport at each of 3 intensities: walking, moderate, and vigorous. Using the instrument's scoring protocol total weekly physical activity was estimated by weighting time spent in each activity intensity with its estimated metabolic equivalent (MET) energy expenditure. The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. Participants will be considered to have met American Collage of Sports Medicine physical activity recommendations. if they reported at least 150 min/wk of walking, moderate, or vigorous intensity physical activity.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">392</enrollment>
  <condition>COVID</condition>
  <condition>Isolation, Social</condition>
  <arm_group>
    <arm_group_label>Turkish society</arm_group_label>
    <description>Individuals speak Turkish and lives in Turkey, ages between 15 - 65, literate and with internet access</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online Survey</intervention_name>
    <description>Volunteer individuals enrolled the study after approval an online informed consent form. Sociodemographic data of the participants recorded as an online survey. Then, patient reported outcomes were used to assess physical activity level (International Physical Actvity Questionairre) and Exercise Benefits and Barriers (Exercise Benefits and Barriers Scale).</description>
    <arm_group_label>Turkish society</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population of the individuals between 15 - 65 ages in Turkey is 56.391.925 people. It&#xD;
        is calculated that there are 42.463.119 individuals cover the criterion as universe of the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being Turkish&#xD;
&#xD;
          -  understanding Turkish&#xD;
&#xD;
          -  being between the age of 15 - 65&#xD;
&#xD;
          -  being literate&#xD;
&#xD;
          -  have internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having a disable condition to exercise&#xD;
&#xD;
          -  having missing value on outcome measures&#xD;
&#xD;
          -  giving incomprehensible answering&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Okan University</name>
      <address>
        <city>Istanbul</city>
        <zip>34959</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Okan University</investigator_affiliation>
    <investigator_full_name>Begüm Okudan</investigator_full_name>
    <investigator_title>MSc. Pt</investigator_title>
  </responsible_party>
  <keyword>Covid 19</keyword>
  <keyword>Physical activity level</keyword>
  <keyword>Exercise benefits and barriers</keyword>
  <keyword>Turkish Society</keyword>
  <keyword>Social Isolation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data wil be stored by researches, if needed for scientific purposes, it can be discussed to share .</ipd_description>
  </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/NCT04412278
org study id: 500600127
nct id: NCT04412278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is aimed to determine the physical activity level and exercise benefits and barriers
      caused by Covid-19 pandemic and reveal the relationship between them.
Study hypothesis that people are tend to be physically inactive while Covid-19 pandemic. It
      is aimed to determine the exercise benefits and barriers caused by Covid-19 pandemic and
      reveal the relationship among gender, age, marial status and physical activity level.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Exercise Benefits and Barriers Scale
time frame: three months after Covid 19 recognised as pandemic
description: The Exercise Benefits/Barriers Scale (EBBS) was developed in response to a need for an instrument to determine perceptions of individuals concerning the benefits of and barriers to participating in exercise. The instrument may be scored and used in its entirety or as two separate scales. The instrument has a four-response, forced-choice Likert-type format with responses ranging from 4 (strongly agree) to 1 (strongly disagree). Scores on the total instrument can range from 43 to 172. The higher the score, the more positively the individual perceives exercise. When the Benefits Scale is used alone, the score range is between 29 and 116. When the Barriers Scale is used alone, scores range between 14 and 56. If used alone, the Barriers Scale does not need to be reverse-scored. In this instance, the higher the score on the Barriers Scale, the greater the perception of barriers to exercise.
measure: Sociodemographic information
time frame: three months after Covid 19 recognised as pandemic
description: Participants will be asked to give information about: age, gender, educational status, height, weight, occupation, working status, whether they have a chronic disease.
measure: International Physical Activity Questionairre
time frame: three months after Covid 19 recognised as pandemic
description: The IPAQ-S developed for participants to report activities performed for at least 10 minutes during the last 7 days. Respondents will be asked to report time spent in physical activity performed across leisure time, work, domestic activities, and transport at each of 3 intensities: walking, moderate, and vigorous. Using the instrument's scoring protocol total weekly physical activity was estimated by weighting time spent in each activity intensity with its estimated metabolic equivalent (MET) energy expenditure. The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. Participants will be considered to have met American Collage of Sports Medicine physical activity recommendations. if they reported at least 150 min/wk of walking, moderate, or vigorous intensity physical activity.
arm group label: Turkish society
description: Individuals speak Turkish and lives in Turkey, ages between 15 - 65, literate and with internet access
intervention type: Other
intervention name: Online Survey
description: Volunteer individuals enrolled the study after approval an online informed consent form. Sociodemographic data of the participants recorded as an online survey. Then, patient reported outcomes were used to assess physical activity level (International Physical Actvity Questionairre) and Exercise Benefits and Barriers (Exercise Benefits and Barriers Scale).
arm group label: Turkish society
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Okan University
investigator full name: Begüm Okudan
investigator title: MSc. Pt
mesh term: COVID-19
sharing ipd: No
ipd description: Data wil be stored by researches, if needed for scientific purposes, it can be discussed to share .