<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/NCT03825614</url>
  </required_header>
  <id_info>
    <org_study_id>UYalova</org_study_id>
    <nct_id>NCT03825614</nct_id>
  </id_info>
  <brief_title>The Effect of Exercises on Young Adults</brief_title>
  <official_title>Does The Pilates or Therapeutic Exercises Effects on Functional Level, Depression, Pain, Qualıty of Life in Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Yalova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Yalova</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 aim of this study was to assess the treatment effect of plates and conventional exercises&#xD;
      on health related quality of life, pain, functional level, psychological state in young&#xD;
      adults. Randomised controlled study. Participants were randomly divided into 3 groups: a&#xD;
      plates exercise group (n = 29), a therapeutic exercise group (n = 21), and a control group (n&#xD;
      = 35). The therapeutic and plates groups underwent related training programs for 3 month,&#xD;
      while the controls had no specific training. After demographic knowledge were collected the&#xD;
      investigators carried out the following assessments on all participants: the Visual Analog&#xD;
      Scale (VAS), Waist/ Hip ratio (WHr), Beck Depression Inventory (BDI), Oswestry Disability&#xD;
      Index (ODI), Notthingham Health Profile (NHP). All subjects were evaluated at baseline and&#xD;
      post-training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized controlled</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of changes in the pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>A visual analogue scale (VAS) was used to their level of pain subjects experienced throughout these activities. The VAS is comprised of a 10 cm horizontal line, wherein 0 indicates &quot;no pain&quot; and 10 indicates &quot;unbearable pain&quot; (Sang, Sang, Dong and Byung, 2016). Participants were asked to mark the strength of their ongoing musculoskeletal pain on the horizontal line.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of changes in the depression</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Back Depression Inventory (BDI) was used to determine patients' level of depression; each item on the scale is given a score of one to three, allowing for a maximum test score of 63 according to form. A subjects' total overall score is then used as an indicator of the presence and severity of depression: a total score lower than 10 indicates no depression, a score of 10-17 indicates mild depression, a score of 18-29 indicates moderate-to-severe depression, and a score of 30 or above indicates severe depression (Muyan, Sancak and Demir, 2017).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Turkish version of the Nottingham Health Profile (NHP) was used to assess participants' health-related quality of life. The NHP is a general quality of life questionnaire that measures individuals' perceived health problems and the extent to which these problems affect their normal daily activities. The questionnaire is comprised of 38 items and evaluates six dimensions of healthy individuals' health statuses, these include: energy (three items), pain (eight items), emotional reactions (nine items), sleep (five items), social isolation (five items) and physical activity (eight items). The test includes a list of yes/no questions. Each section yields a score between 0 and 100 for each subject, where 0 represents the best possible health status and 100 represent the worst possible health status (Liang, Wang and Tao, 2015).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional level</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Oswestry Disability Index (ODI) questionnaires were distributed to participants and scored according to the study by Yakut et al. The research authors noted that some of the questions on the ODI are directly related to physical activities (lifting, walking, etc.). The level of disability was evaluated using the ODI, which is a condition specific questionnaire regarding how low back pain affects activities of daily living. The questionnaire rates 10 different activities based on a six-point scale, with 0 for ''no pain at all'' and 5 for ''cannot perform due to pain''. The higher the score, the greater the disability the subject was deemed to have (Rodríguez-Romero, Bello, Vivas Costa and Carballo-Costa, 2018).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of changes in the Waist and Hip circumference</measure>
    <time_frame>12weeks</time_frame>
    <description>To find the waist/hip (WHr) ratio, participants' waist circumference was taken in centimeters (cm) using a tape measure to measure the point midway between the costal margin and iliac crest on the mid-axillary line, with the subject standing and breathing normally. Hip circumference (cm) was measured at the widest point around the greater trochanter. The waist-to-hip ratios of participants were calculated by dividing their waist measurement by their hip measurement (Tam and Çakır, 2012).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Exercise</condition>
  <condition>Young Adults</condition>
  <condition>Quality of Life</condition>
  <condition>Pain</condition>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>training gruop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The plates exercise program is concerned with the following main principles: efficient breathing, mental concentration, relaxation, correct spine elongation and posture, correct abdominal muscle control over spine stability and mobility, correct function of each upper and lower limb, precision, lowing integrated movement, and achieving muscle strength and stamina.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Therapeutic exercise program was designed according to the American Collage of Sports Medicine's recommendations for healthy people. The exercise program was conducted using low- to moderate-intensity therapeutic exercises. These therapeutic exercises included a short educational talk that provided information on proper body mechanics, the benefits of exercise, realistic goal-setting, and overcoming common barriers (such as fear) when developing an exercise routine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group have no exercise in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>training</intervention_name>
    <description>plates and therapeutic exercises applied on young adults</description>
    <arm_group_label>training group</arm_group_label>
    <arm_group_label>training gruop</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • They were apparently healthy and had no systematic diseases or any problem preventing&#xD;
        their participation in any exercise program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a systemic pathology, including inflammatory, rheumatologic, or metabolic&#xD;
             diseases&#xD;
&#xD;
          -  Having any musculoskeletal injury, pathology, or structural deformity related to the&#xD;
             spine or extremities&#xD;
&#xD;
          -  Having any active intervention including corticosteroid or any medication in the&#xD;
             previous 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>saltan</last_name>
    <role>Principal Investigator</role>
    <affiliation>researcher</affiliation>
  </overall_official>
  <results_reference>
    <citation>Toprak Celenay S, Ozer Kaya D. An 8-week thoracic spine stabilization exercise program improves postural back pain, spine alignment, postural sway, and core endurance in university students:a randomized controlled study. Turk J Med Sci. 2017 Apr 18;47(2):504-513. doi: 10.3906/sag-1511-155.</citation>
    <PMID>28425239</PMID>
  </results_reference>
  <results_reference>
    <citation>Caldwell K, Harrison M, Adams M, Triplett NT. Effect of Pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther. 2009 Apr;13(2):155-63. doi: 10.1016/j.jbmt.2007.12.001. Epub 2008 Feb 20.</citation>
    <PMID>19329051</PMID>
  </results_reference>
  <results_reference>
    <citation>Ozer Kaya D, Duzgun I, Baltaci G, Karacan S, Colakoglu F. Effects of calisthenics and Pilates exercises on coordination and proprioception in adult women: a randomized controlled trial. J Sport Rehabil. 2012 Aug;21(3):235-43. doi: 10.1123/jsr.21.3.235. Epub 2011 Nov 16.</citation>
    <PMID>22104298</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Yalova</investigator_affiliation>
    <investigator_full_name>asuman saltan</investigator_full_name>
    <investigator_title>ASSIST PROF</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <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/NCT03825614
org study id: UYalova
nct id: NCT03825614
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess the treatment effect of plates and conventional exercises
      on health related quality of life, pain, functional level, psychological state in young
      adults. Randomised controlled study. Participants were randomly divided into 3 groups: a
      plates exercise group (n = 29), a therapeutic exercise group (n = 21), and a control group (n
      = 35). The therapeutic and plates groups underwent related training programs for 3 month,
      while the controls had no specific training. After demographic knowledge were collected the
      investigators carried out the following assessments on all participants: the Visual Analog
      Scale (VAS), Waist/ Hip ratio (WHr), Beck Depression Inventory (BDI), Oswestry Disability
      Index (ODI), Notthingham Health Profile (NHP). All subjects were evaluated at baseline and
      post-training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled
primary purpose: Prevention
masking: Single (Investigator)
measure: Assessment of changes in the pain
time frame: 12 weeks
description: A visual analogue scale (VAS) was used to their level of pain subjects experienced throughout these activities. The VAS is comprised of a 10 cm horizontal line, wherein 0 indicates "no pain" and 10 indicates "unbearable pain" (Sang, Sang, Dong and Byung, 2016). Participants were asked to mark the strength of their ongoing musculoskeletal pain on the horizontal line.
measure: Assessment of changes in the depression
time frame: 12 weeks
description: The Back Depression Inventory (BDI) was used to determine patients' level of depression; each item on the scale is given a score of one to three, allowing for a maximum test score of 63 according to form. A subjects' total overall score is then used as an indicator of the presence and severity of depression: a total score lower than 10 indicates no depression, a score of 10-17 indicates mild depression, a score of 18-29 indicates moderate-to-severe depression, and a score of 30 or above indicates severe depression (Muyan, Sancak and Demir, 2017).
measure: Health related quality of life
time frame: 12 weeks
description: The Turkish version of the Nottingham Health Profile (NHP) was used to assess participants' health-related quality of life. The NHP is a general quality of life questionnaire that measures individuals' perceived health problems and the extent to which these problems affect their normal daily activities. The questionnaire is comprised of 38 items and evaluates six dimensions of healthy individuals' health statuses, these include: energy (three items), pain (eight items), emotional reactions (nine items), sleep (five items), social isolation (five items) and physical activity (eight items). The test includes a list of yes/no questions. Each section yields a score between 0 and 100 for each subject, where 0 represents the best possible health status and 100 represent the worst possible health status (Liang, Wang and Tao, 2015).
measure: Functional level
time frame: 12 weeks
description: The Oswestry Disability Index (ODI) questionnaires were distributed to participants and scored according to the study by Yakut et al. The research authors noted that some of the questions on the ODI are directly related to physical activities (lifting, walking, etc.). The level of disability was evaluated using the ODI, which is a condition specific questionnaire regarding how low back pain affects activities of daily living. The questionnaire rates 10 different activities based on a six-point scale, with 0 for ''no pain at all'' and 5 for ''cannot perform due to pain''. The higher the score, the greater the disability the subject was deemed to have (Rodríguez-Romero, Bello, Vivas Costa and Carballo-Costa, 2018).
measure: Assessment of changes in the Waist and Hip circumference
time frame: 12weeks
description: To find the waist/hip (WHr) ratio, participants' waist circumference was taken in centimeters (cm) using a tape measure to measure the point midway between the costal margin and iliac crest on the mid-axillary line, with the subject standing and breathing normally. Hip circumference (cm) was measured at the widest point around the greater trochanter. The waist-to-hip ratios of participants were calculated by dividing their waist measurement by their hip measurement (Tam and Çakır, 2012).
arm group label: training gruop
arm group type: Experimental
description: The plates exercise program is concerned with the following main principles: efficient breathing, mental concentration, relaxation, correct spine elongation and posture, correct abdominal muscle control over spine stability and mobility, correct function of each upper and lower limb, precision, lowing integrated movement, and achieving muscle strength and stamina.
arm group label: training group
arm group type: Active Comparator
description: Therapeutic exercise program was designed according to the American Collage of Sports Medicine's recommendations for healthy people. The exercise program was conducted using low- to moderate-intensity therapeutic exercises. These therapeutic exercises included a short educational talk that provided information on proper body mechanics, the benefits of exercise, realistic goal-setting, and overcoming common barriers (such as fear) when developing an exercise routine.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group have no exercise in this study.
intervention type: Behavioral
intervention name: training
description: plates and therapeutic exercises applied on young adults
arm group label: training group
arm group label: training gruop
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: saltan
role: Principal Investigator
affiliation: researcher
citation: Toprak Celenay S, Ozer Kaya D. An 8-week thoracic spine stabilization exercise program improves postural back pain, spine alignment, postural sway, and core endurance in university students:a randomized controlled study. Turk J Med Sci. 2017 Apr 18;47(2):504-513. doi: 10.3906/sag-1511-155.
PMID: 28425239
citation: Caldwell K, Harrison M, Adams M, Triplett NT. Effect of Pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther. 2009 Apr;13(2):155-63. doi: 10.1016/j.jbmt.2007.12.001. Epub 2008 Feb 20.
PMID: 19329051
citation: Ozer Kaya D, Duzgun I, Baltaci G, Karacan S, Colakoglu F. Effects of calisthenics and Pilates exercises on coordination and proprioception in adult women: a randomized controlled trial. J Sport Rehabil. 2012 Aug;21(3):235-43. doi: 10.1123/jsr.21.3.235. Epub 2011 Nov 16.
PMID: 22104298
responsible party type: Principal Investigator
investigator affiliation: University of Yalova
investigator full name: asuman saltan
investigator title: ASSIST PROF
mesh term: Depression
sharing ipd: No