<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/NCT04490577</url>
  </required_header>
  <id_info>
    <org_study_id>KA18/268</org_study_id>
    <nct_id>NCT04490577</nct_id>
  </id_info>
  <brief_title>Whole-Body Vibration Training and Pilates Exercises for Healthy Women</brief_title>
  <official_title>Comparison of the Effects of Whole-Body Vibration Training and Pilates Exercises on Physical Fitness, Fatigue and Physical Self Perception in Healthy Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent 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>
      This study aimed to compare the effects of whole-body vibration (WBV) training and Pilates&#xD;
      exercises on physical fitness, fatigue, and physical self-perception in healthy women. This&#xD;
      study was carried out on 36 healthy sedentary female subjects. Subjects were divided into&#xD;
      three groups; Pilates training group, WBV training group, and control group. In the Pilates&#xD;
      group, the exercises were performed with &quot;Reformer®&quot; for eight weeks, twice in a week, 45-min&#xD;
      per day. In the WBV group, the training was given &quot;Power Plate®&quot; for eight weeks, twice in a&#xD;
      week, and 30 minutes in a day. The control group did not receive any training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aimed to compare the effects of whole-body vibration (WBV) training and Pilates&#xD;
      exercises on physical fitness, fatigue, and physical self-perception in healthy women aged&#xD;
      between 25-45 years. The study was conducted between August 2018-January 2019 in a health and&#xD;
      physiotherapy clinic. This study was carried out on 36 healthy sedantary female subjects.&#xD;
&#xD;
      Before starting the study, the subjects were divided into three groups in a randomized manner&#xD;
      using &quot;Random Online Allocation Software&quot; (www.Graphpad.com)&#xD;
&#xD;
        1. Group 1: Pilates training group&#xD;
&#xD;
        2. Group 2: WBV training group&#xD;
&#xD;
        3. Group 3: Control group&#xD;
&#xD;
      Pilates training group: The exercises were performed with &quot;Reformer®&quot; for eight weeks, twice&#xD;
      in a week, 45-min per day. Warm-up and cool-down exercises were performed before and after&#xD;
      the training.&#xD;
&#xD;
      WBV training group: The training was given &quot;Power Plate®&quot; for eight weeks, twice in a week,&#xD;
      and 30 minutes in a day. Warm-up and cool-down exercises were performed before and after the&#xD;
      training.&#xD;
&#xD;
      Control group: The control group did not receive any training.&#xD;
&#xD;
      The body composition of the subjects was evaluated with body mass index, waist-hip ratio and&#xD;
      bioelectrical impedance analysis; functional capacity with Shuttle Run Test; core endurance&#xD;
      with lateral bridge test, modified Biering-Sorensen test, trunk flexion test and prone bridge&#xD;
      test and functional core strength with sit-ups and modified push-up tests. The stability of&#xD;
      the core muscles was also measured with a pressure biofeedback instrument. The Sit and Reach&#xD;
      test was used to assess flexibility and the Functional Reach Test was used for balance.&#xD;
      Fatigue was evaluated with The Fatigue Severity Scale and physical self-perception was&#xD;
      assessed with the Physical Self Perception Profile. The subjects were evaluated&#xD;
      pre-intervention and immediately after the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2018</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</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>Factorial Assignment</intervention_model>
    <intervention_model_description>The 36 healthy participants divided into three groups.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Composition Change</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The body composition of the subjects was evaluated with bioelectrical impedance analysis (Tanita BC 601,Tanita Corp., Maeno-Cho, Tokyo, Japan). Body fat proportion was recorded as a percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The body composition of the subjects was evaluated with body mass index (BMI). The BMI is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-hip ratio</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The body composition of the subjects was also evaluated with waist-hip ratio. The waist to hip ratio measurement is calculated by dividing the measurement of your waist by your hip measurement. The score recorded as centimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aerobic capacity</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The aerobic capacity of the participants was evaluated with Shuttle-run test. Shuttle run test involve repetitive running back and forth, either over the same distance, or with changing distances. The shorter trial recorded as seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibility</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The sit and reach test used for flexibility. Sit and reach test measures measures the flexibility of the lower back and hamstring muscles.The score is recorded to the nearest centimeter as the distance reached by the hand.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The balance was evaluated by Functional reach test. The test evaluated dynamic balance and limit of stability. This test measures the distance between the length of an outstretched arm in a maximal forward reach from a standing position,while maintaining a fixed base of support. The score recorded as centimeter. Higher scores indicate good level of balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Self-Perception</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>Physical self-perception was assessed with Physical Self Perception Profile. The questionnaire has four subdomain subscales designed to assess perceived bodily attractiveness, sports competence, physical strength, and physical conditioning were constructed along with a general physical self-worth subscale as the basis of the Physical Self-Perception Profile.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each item consists of statements that are scored on a seven-point Likert type scale ranging from 1 (&quot;strongly disagree&quot;) to 7 (&quot;strongly agree&quot;). The higher scores indicates severe fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lateral Bridge test</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>Lateral bridge test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine. The score recorded as second. Higher scores indicate good level of endurance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Biering-Sorensen test</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>Modified Biering-Sorensen test measuring how many seconds the subject is able to keep the unsupported upper body (from the upper border of the iliac crest) horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest. The score recorded as second. Higher scores indicate good level of endurance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk flexion test</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>Trunk flexion test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed position. The score recorded as second. Higher scores indicate good level of endurance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prone bridge test</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The prone bridge test measures the muscular endurance of the abdominal muscles.The score recorded as second. Higher scores indicate good level of endurance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sit-ups test</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The sit-ups test is a measure the endurance of the abdominal and hip-flexor muscles. The aim of this test is to perform as many sit-ups as you can in two minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified push-up test</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>The modified push-up test was used to measure upper body strength endurance and trunk stability. This variation, which uses a modified technique with a clap behind the back while in the 'down' position and a touch from one hand to the other in the 'up' position.The total number of correctly completed push-ups were recorded.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Lifestyle</condition>
  <condition>Body Weight</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Pilates training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the Pilates group, the exercises were performed with &quot;Reformer®&quot; for eight weeks, twice in a week, one hour per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole-body vibration (WBV) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the WBV group, the training was given &quot;Power Plate®&quot; for eight weeks, twice in a week, and 30 minutes in a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group did not receive any training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates exercises</intervention_name>
    <description>Pilates exercises are a combined exercise procedure including strengthening and stretching. Pilates exercises are performed with different equipment for example; therabands, mats, reformer, etc.</description>
    <arm_group_label>Pilates training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole body vibration</intervention_name>
    <description>Whole-body vibration gives vibration to the body with a platform at different frequencies (Power-plate). The participant performed exercises on the platform.</description>
    <arm_group_label>Whole-body vibration (WBV) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals have not been exercising regularly in the last six months&#xD;
&#xD;
          -  Physical activity level was between 600-3000 MET min/week (Metabolic equivalent&#xD;
             minutes/week) according to the result of the &quot;International Physical Activity&#xD;
             Questionnaire&quot;&#xD;
&#xD;
          -  Bodyweight of less than 130 kg Individuals.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of malignancy&#xD;
&#xD;
          -  Pregnant individuals&#xD;
&#xD;
          -  Musculoskeletal pain due to orthopedic or rheumatic diseases&#xD;
&#xD;
          -  History of fractures in the past year&#xD;
&#xD;
          -  Neurological disease (stroke, epilepsy, etc.)&#xD;
&#xD;
          -  Chronic kidney or liver disease, cardiovascular diseases (cardiac arrhythmia, cardiac&#xD;
             insufficiency, etc.)&#xD;
&#xD;
          -  Imbalance due to peripheral vestibular disorder diagnosis (Benign paroxysmal&#xD;
             positional vertigo, Meniere's disease, etc.)&#xD;
&#xD;
          -  Individuals who not be able to tolerate vibration for more than five minutes were not&#xD;
             included in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozlem Yuruk, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Baskent University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baskent University</name>
      <address>
        <city>Ankara</city>
        <zip>06810</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University</investigator_affiliation>
    <investigator_full_name>Ozlem Yuruk</investigator_full_name>
    <investigator_title>PT, PHD, Assoc Prof</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>Physical fitness</keyword>
  <keyword>Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Body Weight</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/NCT04490577
org study id: KA18/268
nct id: NCT04490577
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to compare the effects of whole-body vibration (WBV) training and Pilates
      exercises on physical fitness, fatigue, and physical self-perception in healthy women. This
      study was carried out on 36 healthy sedentary female subjects. Subjects were divided into
      three groups; Pilates training group, WBV training group, and control group. In the Pilates
      group, the exercises were performed with "Reformer®" for eight weeks, twice in a week, 45-min
      per day. In the WBV group, the training was given "Power Plate®" for eight weeks, twice in a
      week, and 30 minutes in a day. The control group did not receive any training.
This study aimed to compare the effects of whole-body vibration (WBV) training and Pilates
      exercises on physical fitness, fatigue, and physical self-perception in healthy women aged
      between 25-45 years. The study was conducted between August 2018-January 2019 in a health and
      physiotherapy clinic. This study was carried out on 36 healthy sedantary female subjects.

      Before starting the study, the subjects were divided into three groups in a randomized manner
      using "Random Online Allocation Software" (www.Graphpad.com)

        1. Group 1: Pilates training group

        2. Group 2: WBV training group

        3. Group 3: Control group

      Pilates training group: The exercises were performed with "Reformer®" for eight weeks, twice
      in a week, 45-min per day. Warm-up and cool-down exercises were performed before and after
      the training.

      WBV training group: The training was given "Power Plate®" for eight weeks, twice in a week,
      and 30 minutes in a day. Warm-up and cool-down exercises were performed before and after the
      training.

      Control group: The control group did not receive any training.

      The body composition of the subjects was evaluated with body mass index, waist-hip ratio and
      bioelectrical impedance analysis; functional capacity with Shuttle Run Test; core endurance
      with lateral bridge test, modified Biering-Sorensen test, trunk flexion test and prone bridge
      test and functional core strength with sit-ups and modified push-up tests. The stability of
      the core muscles was also measured with a pressure biofeedback instrument. The Sit and Reach
      test was used to assess flexibility and the Functional Reach Test was used for balance.
      Fatigue was evaluated with The Fatigue Severity Scale and physical self-perception was
      assessed with the Physical Self Perception Profile. The subjects were evaluated
      pre-intervention and immediately after the intervention.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: The 36 healthy participants divided into three groups.
primary purpose: Prevention
masking: None (Open Label)
measure: Body Composition Change
time frame: Pre-intervention and immediately after the intervention
description: The body composition of the subjects was evaluated with bioelectrical impedance analysis (Tanita BC 601,Tanita Corp., Maeno-Cho, Tokyo, Japan). Body fat proportion was recorded as a percentage.
measure: Body Mass Index
time frame: Pre-intervention and immediately after the intervention
description: The body composition of the subjects was evaluated with body mass index (BMI). The BMI is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.
measure: Waist-hip ratio
time frame: Pre-intervention and immediately after the intervention
description: The body composition of the subjects was also evaluated with waist-hip ratio. The waist to hip ratio measurement is calculated by dividing the measurement of your waist by your hip measurement. The score recorded as centimeter.
measure: Aerobic capacity
time frame: Pre-intervention and immediately after the intervention
description: The aerobic capacity of the participants was evaluated with Shuttle-run test. Shuttle run test involve repetitive running back and forth, either over the same distance, or with changing distances. The shorter trial recorded as seconds.
measure: Flexibility
time frame: Pre-intervention and immediately after the intervention
description: The sit and reach test used for flexibility. Sit and reach test measures measures the flexibility of the lower back and hamstring muscles.The score is recorded to the nearest centimeter as the distance reached by the hand.
measure: Balance
time frame: Pre-intervention and immediately after the intervention
description: The balance was evaluated by Functional reach test. The test evaluated dynamic balance and limit of stability. This test measures the distance between the length of an outstretched arm in a maximal forward reach from a standing position,while maintaining a fixed base of support. The score recorded as centimeter. Higher scores indicate good level of balance.
measure: Physical Self-Perception
time frame: Pre-intervention and immediately after the intervention
description: Physical self-perception was assessed with Physical Self Perception Profile. The questionnaire has four subdomain subscales designed to assess perceived bodily attractiveness, sports competence, physical strength, and physical conditioning were constructed along with a general physical self-worth subscale as the basis of the Physical Self-Perception Profile.
measure: Fatigue Severity Scale
time frame: Pre-intervention and immediately after the intervention
description: The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each item consists of statements that are scored on a seven-point Likert type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The higher scores indicates severe fatigue.
measure: Lateral Bridge test
time frame: Pre-intervention and immediately after the intervention
description: Lateral bridge test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine. The score recorded as second. Higher scores indicate good level of endurance.
measure: Modified Biering-Sorensen test
time frame: Pre-intervention and immediately after the intervention
description: Modified Biering-Sorensen test measuring how many seconds the subject is able to keep the unsupported upper body (from the upper border of the iliac crest) horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest. The score recorded as second. Higher scores indicate good level of endurance.
measure: Trunk flexion test
time frame: Pre-intervention and immediately after the intervention
description: Trunk flexion test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed position. The score recorded as second. Higher scores indicate good level of endurance.
measure: Prone bridge test
time frame: Pre-intervention and immediately after the intervention
description: The prone bridge test measures the muscular endurance of the abdominal muscles.The score recorded as second. Higher scores indicate good level of endurance.
measure: Sit-ups test
time frame: Pre-intervention and immediately after the intervention
description: The sit-ups test is a measure the endurance of the abdominal and hip-flexor muscles. The aim of this test is to perform as many sit-ups as you can in two minutes.
measure: Modified push-up test
time frame: Pre-intervention and immediately after the intervention
description: The modified push-up test was used to measure upper body strength endurance and trunk stability. This variation, which uses a modified technique with a clap behind the back while in the 'down' position and a touch from one hand to the other in the 'up' position.The total number of correctly completed push-ups were recorded.
arm group label: Pilates training group
arm group type: Experimental
description: In the Pilates group, the exercises were performed with "Reformer®" for eight weeks, twice in a week, one hour per day.
arm group label: Whole-body vibration (WBV) group
arm group type: Experimental
description: In the WBV group, the training was given "Power Plate®" for eight weeks, twice in a week, and 30 minutes in a day.
arm group label: Control group
arm group type: No Intervention
description: The control group did not receive any training.
intervention type: Other
intervention name: Pilates exercises
description: Pilates exercises are a combined exercise procedure including strengthening and stretching. Pilates exercises are performed with different equipment for example; therabands, mats, reformer, etc.
arm group label: Pilates training group
intervention type: Other
intervention name: Whole body vibration
description: Whole-body vibration gives vibration to the body with a platform at different frequencies (Power-plate). The participant performed exercises on the platform.
arm group label: Whole-body vibration (WBV) group
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ozlem Yuruk, Assoc. Prof.
role: Study Director
affiliation: Baskent University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Baskent University
investigator full name: Ozlem Yuruk
investigator title: PT, PHD, Assoc Prof
mesh term: Fatigue
mesh term: Body Weight