xml: <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/NCT05970523</url>
    </required_header>
    <id_info>
      <org_study_id>E-10840098-772.02-2555</org_study_id>
      <nct_id>NCT05970523</nct_id>
    </id_info>
    <brief_title>The Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture on Sedentary Individuals</brief_title>
    <official_title>Investigation of the Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture in Healthy Sedentary Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medipol University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medipol 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>
        There are very few studies on the effect of core stabilization exercises on balance, posture&#xD;
        and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the&#xD;
        study is to investigate the effects of core stabilization exercises on balance, trunk muscle&#xD;
        endurance and posture in healthy sedentary individuals. According to the results of&#xD;
        International Physical Activity Questionnaire, the researcher includes sedentary individuals&#xD;
        over the age of 18 in the study. The participants are divided into two groups as control&#xD;
        (n=21) and exercise (n=21) groups. The outcome measures are The Stabilizer Pressure&#xD;
        Biofeedback Unit, New York Posture Assesment Scale, Korebalance Balance System, trunk muscle&#xD;
        endurance tests. Intervention includes core stabilization exercises 3 times a week and&#xD;
        walking twice a week for 6 weeks. There is no treatment or intervention for the control&#xD;
        group. The researcher evaluates both groups at the beginning and 6 weeks after the&#xD;
        intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Core stabilization exercises are performed under the supervision of a physiotherapist as&#xD;
        face-to-face exercises, guided online exercises, and as an individual home exercise each once&#xD;
        a week, totaling 3 times a week. Each exercise will be performed with 10 repetitions for 8&#xD;
        seconds. Each of the exercises is varied from easy to difficult. Progress in the exercises&#xD;
        will be achieved by increasing the difficulty level of the exercises according to the&#xD;
        condition of the participant once every two weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 27, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Stabilizer Pressure Biofeedback Unite</measure>
      <time_frame>6 weeks</time_frame>
      <description>This device evaluates contraction of deep abdominal muscles, muscle activity and segmental stability. The device has values between 0 mmHg and 200 mmHg, varying in intervals of 2 mmHg. Movement or change in position causes volume changes in the pressure bag.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>New York Posture Assessment Scale</measure>
      <time_frame>6 weeks</time_frame>
      <description>This test assesses alignment of various body parts of an individual in anatomical position. The New York Posture Rating Scale detects postural changes that may occur in 13 different parts of the body (back views of the head, shoulders, spine, hips, feet, and arches, and side (left side) views of the neck, chest, shoulders, back, trunk, abdomen, and waist). There are 3 figure drawings for each of the 13 different body parts that provide general postural alignment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>KoreBalance Balance System</measure>
      <time_frame>6 weeks</time_frame>
      <description>The Korebalance Balance System is a computerized balance and exercise system. The software of the system assigns a score following static and dynamic balance evaluations. A higher score is associated with more balance disorders.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trunk Muscle Endurance Tests</measure>
      <time_frame>6 weeks</time_frame>
      <description>A number of isometric tests have been described for the evaluation of trunk extensor, flexor, and lateral flexor muscles. The endurance of the trunk flexor, trunk extensor and lateral flexor muscles is evaluated. Generally, in these tests, the evaluation is made by recording the maximum time that the person whose endurance is evaluated can maintain the test position. Measurements are made using a stopwatch and the result is recorded in seconds. The tests are repeated twice to save the best measurement value. Tests are terminated when the participant's position deteriorates or when the participant says he or she cannot continue the test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Physical Activity Questionnaire</measure>
      <time_frame>Before Intervention (First Assesment)</time_frame>
      <description>The International Physical Activity Questionnaire is a scale developed by researchers from various countries with the support of the World Health Organization and the Centers for Disease Control. This survey lists activities and requests estimates of duration and frequency for each activity performed in the past week. The times are multiplied by the known Metabolic Equivalents (METs) per activity and the results for all items are summed, resulting in the overall physical activity score.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Core Stabilization</condition>
    <condition>Sedentary Behavior</condition>
    <arm_group>
      <arm_group_label>Exercise Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention includes core stabilization exercises for 45 minutes 3 times a week. Participants do exercise face to face under supervision of a physiotherapist and via an online application under the supervision of a physiotherapist once a week. Also participants do home exercise once a week. Exercise group walk for an hour in other two days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>There is no exercise or intervention for control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Core Stabilization Exercises</intervention_name>
      <description>Core stabilization exercises are known as a very effective exercise method based on the motor learning principle, performed with the individual's own body weight to strengthen the muscles, improve balance, posture, trunk muscle endurance and flexibility.</description>
      <arm_group_label>Exercise Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be voluntary to participate in the study&#xD;
  &#xD;
            -  Being between the ages of 18-40&#xD;
  &#xD;
            -  Being sedentary&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not volunteering to participate in the study&#xD;
  &#xD;
            -  Having a complaint of low back pain in the last two months&#xD;
  &#xD;
            -  Being pregnant&#xD;
  &#xD;
            -  Having chronic lower extremity pain&#xD;
  &#xD;
            -  Having an orthopedic disease and undergoing a surgical operation&#xD;
  &#xD;
            -  Having had abdominal surgery&#xD;
  &#xD;
            -  Being a neurological disease pathology&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ayşe Nur Tunali, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Medipol University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Beyza Nur Yumak</last_name>
      <phone>+ (90) 5398561470</phone>
      <email>beyzanurymk@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beyza Nur Yumak</name>
        <address>
          <city>Istanbul</city>
          <zip>34126</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Beyza Yumak</last_name>
        <phone>+90 539 856 1470</phone>
        <email>beyzanurymk@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70. Erratum In: J Strength Cond Res. 2011 Jan;25(1):286.</citation>
      <PMID>20940644</PMID>
    </results_reference>
    <results_reference>
      <citation>Hung KC, Chung HW, Yu CC, Lai HC, Sun FH. Effects of 8-week core training on core endurance and running economy. PLoS One. 2019 Mar 8;14(3):e0213158. doi: 10.1371/journal.pone.0213158. eCollection 2019.</citation>
      <PMID>30849105</PMID>
    </results_reference>
    <results_reference>
      <citation>von Garnier K, Koveker K, Rackwitz B, Kober U, Wilke S, Ewert T, Stucki G. Reliability of a test measuring transversus abdominis muscle recruitment with a pressure biofeedback unit. Physiotherapy. 2009 Mar;95(1):8-14. doi: 10.1016/j.physio.2008.10.003. Epub 2009 Jan 22.</citation>
      <PMID>19627680</PMID>
    </results_reference>
    <results_reference>
      <citation>Dogruoz Karatekin B, Yasin S, Yumusakhuylu Y, Bayram F, Icagasioglu A. Validity of the Korebalance(R) Balance System in Patients with Postmenopausal Osteoporosis. Medeni Med J. 2020;35(2):79-84. doi: 10.5222/MMJ.2020.18828. Epub 2020 Jun 30.</citation>
      <PMID>32733755</PMID>
    </results_reference>
    <results_reference>
      <citation>Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.</citation>
      <PMID>17141568</PMID>
    </results_reference>
    <results_reference>
      <citation>Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.</citation>
      <PMID>21058606</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medipol University</investigator_affiliation>
      <investigator_full_name>Beyza Nur Yumak</investigator_full_name>
      <investigator_title>Researcher</investigator_title>
    </responsible_party>
    <keyword>Trunk Muscle Endurance</keyword>
    <keyword>Balance</keyword>
    <keyword>Posture</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970523
  org study id: E-10840098-772.02-2555
  nct id: NCT05970523
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There are very few studies on the effect of core stabilization exercises on balance, posture
        and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the
        study is to investigate the effects of core stabilization exercises on balance, trunk muscle
        endurance and posture in healthy sedentary individuals. According to the results of
        International Physical Activity Questionnaire, the researcher includes sedentary individuals
        over the age of 18 in the study. The participants are divided into two groups as control
        (n=21) and exercise (n=21) groups. The outcome measures are The Stabilizer Pressure
        Biofeedback Unit, New York Posture Assesment Scale, Korebalance Balance System, trunk muscle
        endurance tests. Intervention includes core stabilization exercises 3 times a week and
        walking twice a week for 6 weeks. There is no treatment or intervention for the control
        group. The researcher evaluates both groups at the beginning and 6 weeks after the
        intervention.
  Core stabilization exercises are performed under the supervision of a physiotherapist as
        face-to-face exercises, guided online exercises, and as an individual home exercise each once
        a week, totaling 3 times a week. Each exercise will be performed with 10 repetitions for 8
        seconds. Each of the exercises is varied from easy to difficult. Progress in the exercises
        will be achieved by increasing the difficulty level of the exercises according to the
        condition of the participant once every two weeks.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The Stabilizer Pressure Biofeedback Unite
  time frame: 6 weeks
  description: This device evaluates contraction of deep abdominal muscles, muscle activity and segmental stability. The device has values between 0 mmHg and 200 mmHg, varying in intervals of 2 mmHg. Movement or change in position causes volume changes in the pressure bag.
  measure: New York Posture Assessment Scale
  time frame: 6 weeks
  description: This test assesses alignment of various body parts of an individual in anatomical position. The New York Posture Rating Scale detects postural changes that may occur in 13 different parts of the body (back views of the head, shoulders, spine, hips, feet, and arches, and side (left side) views of the neck, chest, shoulders, back, trunk, abdomen, and waist). There are 3 figure drawings for each of the 13 different body parts that provide general postural alignment.
  measure: KoreBalance Balance System
  time frame: 6 weeks
  description: The Korebalance Balance System is a computerized balance and exercise system. The software of the system assigns a score following static and dynamic balance evaluations. A higher score is associated with more balance disorders.
  measure: Trunk Muscle Endurance Tests
  time frame: 6 weeks
  description: A number of isometric tests have been described for the evaluation of trunk extensor, flexor, and lateral flexor muscles. The endurance of the trunk flexor, trunk extensor and lateral flexor muscles is evaluated. Generally, in these tests, the evaluation is made by recording the maximum time that the person whose endurance is evaluated can maintain the test position. Measurements are made using a stopwatch and the result is recorded in seconds. The tests are repeated twice to save the best measurement value. Tests are terminated when the participant's position deteriorates or when the participant says he or she cannot continue the test.
  measure: International Physical Activity Questionnaire
  time frame: Before Intervention (First Assesment)
  description: The International Physical Activity Questionnaire is a scale developed by researchers from various countries with the support of the World Health Organization and the Centers for Disease Control. This survey lists activities and requests estimates of duration and frequency for each activity performed in the past week. The times are multiplied by the known Metabolic Equivalents (METs) per activity and the results for all items are summed, resulting in the overall physical activity score.
  arm group label: Exercise Group
  arm group type: Experimental
  description: Intervention includes core stabilization exercises for 45 minutes 3 times a week. Participants do exercise face to face under supervision of a physiotherapist and via an online application under the supervision of a physiotherapist once a week. Also participants do home exercise once a week. Exercise group walk for an hour in other two days.
  arm group label: Control Group
  arm group type: No Intervention
  description: There is no exercise or intervention for control group.
  intervention type: Other
  intervention name: Core Stabilization Exercises
  description: Core stabilization exercises are known as a very effective exercise method based on the motor learning principle, performed with the individual's own body weight to strengthen the muscles, improve balance, posture, trunk muscle endurance and flexibility.
  arm group label: Exercise Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ayşe Nur Tunali, Professor
  role: Study Director
  affiliation: Medipol University
  last name: Beyza Nur Yumak
  phone: + (90) 5398561470
  email: beyzanurymk@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70. Erratum In: J Strength Cond Res. 2011 Jan;25(1):286.
  PMID: 20940644
  citation: Hung KC, Chung HW, Yu CC, Lai HC, Sun FH. Effects of 8-week core training on core endurance and running economy. PLoS One. 2019 Mar 8;14(3):e0213158. doi: 10.1371/journal.pone.0213158. eCollection 2019.
  PMID: 30849105
  citation: von Garnier K, Koveker K, Rackwitz B, Kober U, Wilke S, Ewert T, Stucki G. Reliability of a test measuring transversus abdominis muscle recruitment with a pressure biofeedback unit. Physiotherapy. 2009 Mar;95(1):8-14. doi: 10.1016/j.physio.2008.10.003. Epub 2009 Jan 22.
  PMID: 19627680
  citation: Dogruoz Karatekin B, Yasin S, Yumusakhuylu Y, Bayram F, Icagasioglu A. Validity of the Korebalance(R) Balance System in Patients with Postmenopausal Osteoporosis. Medeni Med J. 2020;35(2):79-84. doi: 10.5222/MMJ.2020.18828. Epub 2020 Jun 30.
  PMID: 32733755
  citation: Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.
  PMID: 17141568
  citation: Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
  PMID: 21058606
  responsible party type: Principal Investigator
  investigator affiliation: Medipol University
  investigator full name: Beyza Nur Yumak
  investigator title: Researcher
  sharing ipd: No