<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/NCT03030456</url>
  </required_header>
  <id_info>
    <org_study_id>57756916.0.0000.5343</org_study_id>
    <nct_id>NCT03030456</nct_id>
  </id_info>
  <brief_title>Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders</brief_title>
  <official_title>Evaluation of the Effects of Whole Body Vibration Training on Functional Capacity, Muscle Strength, and Biochemical Profile in Elderly Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Santa Cruz do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Santa Cruz do Sul</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized clinical trial that has as objective to evaluate the effects of&#xD;
      training with a vibratory platform on body composition, muscular strength functional&#xD;
      capacity, flexibility and biochemical profile on elderly women. It will be done in the city&#xD;
      of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80&#xD;
      years-old, within the municipal limits and nearby areas selected randomly by a brown envelope&#xD;
      in which a note will be stating if they belong to the control or vibratory platform group, in&#xD;
      which the participant will be receiving whole body vibrations on the platform. The recruiting&#xD;
      will be done by the institution through e-mail or by public call.&#xD;
&#xD;
      Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied,&#xD;
      in order to evaluate if they don´t have counterindications for the vibratory platform. They&#xD;
      will be evaluated in their general health, socio-economical status, and history of physical&#xD;
      activity. Participants will have their doubts cleared about the study, and a written consent&#xD;
      will be signed. Before the intervention with whole body vibrations, nutritional and physical&#xD;
      activity aspects will be evaluated. The treatment period on the vibratory platform will be of&#xD;
      8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility, palmar&#xD;
      prehension strength, metabolic basal load, and functional capacity measurements will be&#xD;
      taken. Before and after every session on the vibratory platform, heart rate, respiratory&#xD;
      rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The&#xD;
      interventional procedure will be done with a vibratory platform (Power Plate®, model my7™,&#xD;
      UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will&#xD;
      last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training,&#xD;
      and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee&#xD;
      flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the&#xD;
      amplitude of 2 mm.&#xD;
&#xD;
      The study aims to contribute with reducing the body mass index and body fat percentage, to&#xD;
      improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and&#xD;
      flexibility, also obtaining better biochemical profiles after the training period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After evaluating the anamnesis and having the written consent signed and clarified, the&#xD;
      elderly women will be evaluated before and after the intervention period of 8 weeks of&#xD;
      training on the vibratory platform. First, academics from the nutrition degree of the&#xD;
      University of Santa Cruz do Sul (UNISC) will perform nutritional evaluations on the subjects,&#xD;
      asking them their 24 hour eating habits, there will not be any interference on the subjects&#xD;
      diet, also they will have to keep these habits until the end of the trial. Then there will be&#xD;
      a socio-economical indicators evaluation through a questionnaire of socio-economical&#xD;
      classification from the Brazilian Association of Research Companies.The evaluation of their&#xD;
      level of physical activity will be done by the International Physical Activity Questionnaire.&#xD;
      The anthropometrical evaluation will consider height, weight, body mass index, waist&#xD;
      circumference, hip circumference, and hip-waist ratio. Body fat percentage, lean mass, and&#xD;
      basal metabolic rate will be obtained through bioimpedance (Biodynamics 450, USA),&#xD;
      recommending 5 hours fasting prior to the procedure. Biochemical tests will be done&#xD;
      collecting blood at the University of Santa Cruz Exercise Biochemistry Laboratory, on the&#xD;
      following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric&#xD;
      acid. Oxidative stress evaluation with the Thiobarbituric acid reactive substances (TBARS)&#xD;
      test will be done after urine collection once a week, before intervention and immediately&#xD;
      after the session. Control group subjects will have urine collected twice: on the day when&#xD;
      cards will be handed in and on the last day of evaluations. Physical evaluation will be done&#xD;
      in the week prior to the intervention with the vibratory platform and in the last week of&#xD;
      treatment, where flexibility through Wells Bank will be evaluated, as well as lower limb&#xD;
      muscular strength by the maximum repetitions test, and palmar prehension strength will be&#xD;
      obtained through dynamometer. Functional Capacity will be evaluated with the six minute walk&#xD;
      test.&#xD;
&#xD;
      The intervention procedure with the vibratory platform (Power Plate®, model my7™, UK) will&#xD;
      last 8 weeks, 3 times a week with work periods lasting between 30 seconds and 1 hour and rest&#xD;
      periods of 30 seconds to 1 minute with a total session time of 10 to 20 minutes. The&#xD;
      individual will be then positioned in orthosis with a knee flexion of a 15° and a foot width&#xD;
      distance of 20 cm. A frequency of 35 Hz and an amplitude of 2 mm will be used. The protocol&#xD;
      with number of session, time of session, time of vibrations and rest, is as follows: 1st&#xD;
      through 6th session, total time of 10 minutes, with 30 seconds of vibration alternated with 1&#xD;
      minute rest; 7th through 12th session, total time of 10 minutes, vibrations and rest time of&#xD;
      1 minute each; 13th trough 18th session, total session time of 15 minutes, vibrations and&#xD;
      rest time of 1 minute each, 19th through 24th session, total time of 20 minutes, time of&#xD;
      vibration 1 minute and rest time of 30 seconds.&#xD;
&#xD;
      Statistical analysis: This will be done using the Statistical Package for Social Science&#xD;
      (Version 23.0 USA) program. To test data normality the investigators will use the&#xD;
      Kolmogorov-Smirnov test. Parametric data will be presented in mean and standard deviation and&#xD;
      non-parametric data in median and interquartile intervals. The intragroup deltas from the pre&#xD;
      and post training periods on the vibratory platform on both groups will be evaluated through&#xD;
      Student´s T Test (paired T test or non-parametric equivalent for intergroup comparisons).&#xD;
&#xD;
      To evaluate body composition, metabolic rate, palmar prehension strength, flexibility,&#xD;
      muscular strength, distance traveled through the Six minute walking test (6SMWT), biochemical&#xD;
      profile and oxidative stress between the groups evaluated pre and post training period, a&#xD;
      Student´s T test will be used. Significance level will be p &lt; 0,05.&#xD;
&#xD;
      Sample size: It was based on a previous study by Rees et al. (2008). To detect a difference&#xD;
      of 8,9 W/Kg between knee flexion torque pre and post training on the vibratory platform,&#xD;
      considering a p value &lt; 0,05, a statistical power of 80% and a 10% loss, 34 subjects will be&#xD;
      needed in each group to be evaluated in pre and post training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of whole body vibrations training on Functional Capacity in Elderly Women.</measure>
    <time_frame>eight weeks</time_frame>
    <description>Functional Capacity will be measured through distance traveled with the six minute walk test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of whole body vibrations training on Muscle Strength in Elderly Women.</measure>
    <time_frame>eight weeks</time_frame>
    <description>Muscular strength will be measured by the maximum repetitions test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of whole body vibrations training on Biochemical Profile in Elderly Women.</measure>
    <time_frame>eight weeks</time_frame>
    <description>Biochemical profile will be measured through blood collection and there will be a result (number) for each one of the following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric acid. Oxidative stress will be measured through TBARS test, which will present a numerical result.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Aging</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Elderly women receiving a list of general health orientations through an 8 week period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Power Plate®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Power Plate®: training of elderly women</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Power Plate®</intervention_name>
    <description>Training of elderly women with Whole Body Vibrations through the use of a vibratory platform.</description>
    <arm_group_label>Power Plate®</arm_group_label>
    <other_name>Whole Body Vibrations</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged 60 or older.&#xD;
&#xD;
          -  Non-physical activity practicing elderly women.&#xD;
&#xD;
          -  Maximum weight of 159 kg.&#xD;
&#xD;
          -  BMI between 18 and 39 kg/m².&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic arterial hypertension, (systolic arterial pressure &gt;140 mmHg or diastolic&#xD;
             arterial pressure &gt;90 mmHg).&#xD;
&#xD;
          -  Cognitive compromising neutropenia.&#xD;
&#xD;
          -  Individual subject to surgical procedures, where bone prosthetics has been implanted&#xD;
             or cardiac pacemaker.&#xD;
&#xD;
          -  Individuals diagnosed with labyrinthitis, disc hernia, thrombosis,decompensated&#xD;
             diabetes or cancer.&#xD;
&#xD;
          -  Cognitive deficit.&#xD;
&#xD;
          -  Orthopedic deficit which makes participation impossible.&#xD;
&#xD;
          -  Persistent discomfort after using the vibratory platform.&#xD;
&#xD;
          -  Individuals missing three consecutive training sessions on the vibratory platform.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Greice Raquel Machado</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masters Student</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Santa Cruz do Sul</investigator_affiliation>
    <investigator_full_name>Greice Raquel Machado</investigator_full_name>
    <investigator_title>PHYSICAL THERAPIST</investigator_title>
  </responsible_party>
  <keyword>whole body vibration</keyword>
  <keyword>Oxidative Stress</keyword>
  <keyword>Aged</keyword>
  <keyword>Biochemical profile</keyword>
  <keyword>muscle strength</keyword>
  <keyword>flexibility</keyword>
  <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/NCT03030456
org study id: 57756916.0.0000.5343
nct id: NCT03030456
lead sponsor: 
has dmc: No
This study is a randomized clinical trial that has as objective to evaluate the effects of
      training with a vibratory platform on body composition, muscular strength functional
      capacity, flexibility and biochemical profile on elderly women. It will be done in the city
      of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80
      years-old, within the municipal limits and nearby areas selected randomly by a brown envelope
      in which a note will be stating if they belong to the control or vibratory platform group, in
      which the participant will be receiving whole body vibrations on the platform. The recruiting
      will be done by the institution through e-mail or by public call.

      Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied,
      in order to evaluate if they don´t have counterindications for the vibratory platform. They
      will be evaluated in their general health, socio-economical status, and history of physical
      activity. Participants will have their doubts cleared about the study, and a written consent
      will be signed. Before the intervention with whole body vibrations, nutritional and physical
      activity aspects will be evaluated. The treatment period on the vibratory platform will be of
      8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility, palmar
      prehension strength, metabolic basal load, and functional capacity measurements will be
      taken. Before and after every session on the vibratory platform, heart rate, respiratory
      rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The
      interventional procedure will be done with a vibratory platform (Power Plate®, model my7™,
      UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will
      last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training,
      and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee
      flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the
      amplitude of 2 mm.

      The study aims to contribute with reducing the body mass index and body fat percentage, to
      improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and
      flexibility, also obtaining better biochemical profiles after the training period.
After evaluating the anamnesis and having the written consent signed and clarified, the
      elderly women will be evaluated before and after the intervention period of 8 weeks of
      training on the vibratory platform. First, academics from the nutrition degree of the
      University of Santa Cruz do Sul (UNISC) will perform nutritional evaluations on the subjects,
      asking them their 24 hour eating habits, there will not be any interference on the subjects
      diet, also they will have to keep these habits until the end of the trial. Then there will be
      a socio-economical indicators evaluation through a questionnaire of socio-economical
      classification from the Brazilian Association of Research Companies.The evaluation of their
      level of physical activity will be done by the International Physical Activity Questionnaire.
      The anthropometrical evaluation will consider height, weight, body mass index, waist
      circumference, hip circumference, and hip-waist ratio. Body fat percentage, lean mass, and
      basal metabolic rate will be obtained through bioimpedance (Biodynamics 450, USA),
      recommending 5 hours fasting prior to the procedure. Biochemical tests will be done
      collecting blood at the University of Santa Cruz Exercise Biochemistry Laboratory, on the
      following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric
      acid. Oxidative stress evaluation with the Thiobarbituric acid reactive substances (TBARS)
      test will be done after urine collection once a week, before intervention and immediately
      after the session. Control group subjects will have urine collected twice: on the day when
      cards will be handed in and on the last day of evaluations. Physical evaluation will be done
      in the week prior to the intervention with the vibratory platform and in the last week of
      treatment, where flexibility through Wells Bank will be evaluated, as well as lower limb
      muscular strength by the maximum repetitions test, and palmar prehension strength will be
      obtained through dynamometer. Functional Capacity will be evaluated with the six minute walk
      test.

      The intervention procedure with the vibratory platform (Power Plate®, model my7™, UK) will
      last 8 weeks, 3 times a week with work periods lasting between 30 seconds and 1 hour and rest
      periods of 30 seconds to 1 minute with a total session time of 10 to 20 minutes. The
      individual will be then positioned in orthosis with a knee flexion of a 15° and a foot width
      distance of 20 cm. A frequency of 35 Hz and an amplitude of 2 mm will be used. The protocol
      with number of session, time of session, time of vibrations and rest, is as follows: 1st
      through 6th session, total time of 10 minutes, with 30 seconds of vibration alternated with 1
      minute rest; 7th through 12th session, total time of 10 minutes, vibrations and rest time of
      1 minute each; 13th trough 18th session, total session time of 15 minutes, vibrations and
      rest time of 1 minute each, 19th through 24th session, total time of 20 minutes, time of
      vibration 1 minute and rest time of 30 seconds.

      Statistical analysis: This will be done using the Statistical Package for Social Science
      (Version 23.0 USA) program. To test data normality the investigators will use the
      Kolmogorov-Smirnov test. Parametric data will be presented in mean and standard deviation and
      non-parametric data in median and interquartile intervals. The intragroup deltas from the pre
      and post training periods on the vibratory platform on both groups will be evaluated through
      Student´s T Test (paired T test or non-parametric equivalent for intergroup comparisons).

      To evaluate body composition, metabolic rate, palmar prehension strength, flexibility,
      muscular strength, distance traveled through the Six minute walking test (6SMWT), biochemical
      profile and oxidative stress between the groups evaluated pre and post training period, a
      Student´s T test will be used. Significance level will be p < 0,05.

      Sample size: It was based on a previous study by Rees et al. (2008). To detect a difference
      of 8,9 W/Kg between knee flexion torque pre and post training on the vibratory platform,
      considering a p value < 0,05, a statistical power of 80% and a 10% loss, 34 subjects will be
      needed in each group to be evaluated in pre and post training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Effects of whole body vibrations training on Functional Capacity in Elderly Women.
time frame: eight weeks
description: Functional Capacity will be measured through distance traveled with the six minute walk test.
measure: Effects of whole body vibrations training on Muscle Strength in Elderly Women.
time frame: eight weeks
description: Muscular strength will be measured by the maximum repetitions test.
measure: Effects of whole body vibrations training on Biochemical Profile in Elderly Women.
time frame: eight weeks
description: Biochemical profile will be measured through blood collection and there will be a result (number) for each one of the following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric acid. Oxidative stress will be measured through TBARS test, which will present a numerical result.
arm group label: Control Group
arm group type: No Intervention
description: Elderly women receiving a list of general health orientations through an 8 week period
arm group label: Power Plate®
arm group type: Experimental
description: Power Plate®: training of elderly women
intervention type: Device
intervention name: Power Plate®
description: Training of elderly women with Whole Body Vibrations through the use of a vibratory platform.
arm group label: Power Plate®
other name: Whole Body Vibrations
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Greice Raquel Machado
role: Principal Investigator
affiliation: Masters Student
responsible party type: Principal Investigator
investigator affiliation: University of Santa Cruz do Sul
investigator full name: Greice Raquel Machado
investigator title: PHYSICAL THERAPIST
sharing ipd: No