<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/NCT01681719</url>
  </required_header>
  <id_info>
    <org_study_id>ERGOFORCE1</org_study_id>
    <nct_id>NCT01681719</nct_id>
  </id_info>
  <brief_title>Ergospirometric Values and WBV in Elderly</brief_title>
  <acronym>EVAWIE</acronym>
  <official_title>Whole Body Vibration as Alternative for Improve the Ergospirometric Values in Elderly: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maíra F Pessoa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Pernambuco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      this study aims evaluate the ergospirometric values after 03 months of training with WBV in&#xD;
      elderly health people. The hypothesis is increases of ergospirometric values.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <primary_completion_date type="Actual">December 2011</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximal O2 consumption</measure>
    <time_frame>started and finished the protocol after 03 months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>WBV and resistance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>used both interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WBV &amp; resistance sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>used the vibrating platform and sham for resistance training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance &amp; sham WBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>used resistance exercises and sham for vibrating platform</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WBV and Resistance</intervention_name>
    <description>use of WBV and resistance device during 03 months in elderly health people. The WBV used progressive increases of time and amplitude and the resistance training improves the weight.&#xD;
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.&#xD;
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.</description>
    <arm_group_label>WBV and resistance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>resistance &amp; sham WBV</intervention_name>
    <description>used only resistance&#xD;
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.&#xD;
For WBV: used MY3 platform (Power Plate®, MY3, UK)off.</description>
    <arm_group_label>Resistance &amp; sham WBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WBV &amp; resistance sham</intervention_name>
    <description>used really the WBV, but sham for resistance training&#xD;
For Resistance: performed similar movments in upper and lower limbs in weight machine Mega II Movement®, without using weights.&#xD;
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.</description>
    <arm_group_label>WBV &amp; resistance sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 60-74 years,&#xD;
&#xD;
          -  Sedentary or Moderate A in accord with IPAQ short form (International Physical&#xD;
             Activity Questionnaire) and those without disease.&#xD;
&#xD;
          -  furthermore, the subjects should reach the ventilatory threshold 1, considered after&#xD;
             meeting two of the following events:&#xD;
&#xD;
          -  respiratory quotient (R) increases (R ≥1,1);&#xD;
&#xD;
          -  loss of linearity between the pulmonary ventilation curve (VE) and oxygen consumption&#xD;
             (VO2), plateau of VO2 or plateau of heart rate (HR) and increases of end-tidal PO2&#xD;
             (Pet O2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Were excluded subjects with changes in Mini-mental state examination (MMSE) scores by&#xD;
             age and educational level where the minimum score represents: illiterate 13 points,&#xD;
             less than 8 study years is 18 points, 8 or more study years is 26 points 11.&#xD;
&#xD;
          -  Were also excluded current smokers or previous, subjects with thrombosis,&#xD;
             labyrinthitis, diabetes, hemodynamic instabilities, obesity, osteoporosis,&#xD;
             neuromuscular diseases, pulmonary or cardiac diseases, changes in resting&#xD;
             electrocardiogram or in exercise, ingestion of drugs to metabolism bone / muscle /&#xD;
             heart chronotropism or with difficulties in adapting protocols&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UFPE</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50740-560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 5, 2012</last_update_submitted>
  <last_update_submitted_qc>September 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Maíra F Pessoa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>VO2</keyword>
  <keyword>VCO2</keyword>
  <keyword>VE/VO2</keyword>
  <keyword>heart rate</keyword>
  <!-- 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/NCT01681719
org study id: ERGOFORCE1
nct id: NCT01681719
lead sponsor: 
has dmc: Yes
this study aims evaluate the ergospirometric values after 03 months of training with WBV in
      elderly health people. The hypothesis is increases of ergospirometric values.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: maximal O2 consumption
time frame: started and finished the protocol after 03 months
arm group label: WBV and resistance
arm group type: Experimental
description: used both interventions
arm group label: WBV & resistance sham
arm group type: Experimental
description: used the vibrating platform and sham for resistance training
arm group label: Resistance & sham WBV
arm group type: Experimental
description: used resistance exercises and sham for vibrating platform
intervention type: Device
intervention name: WBV and Resistance
description: use of WBV and resistance device during 03 months in elderly health people. The WBV used progressive increases of time and amplitude and the resistance training improves the weight.
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.
arm group label: WBV and resistance
intervention type: Device
intervention name: resistance & sham WBV
description: used only resistance
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
For WBV: used MY3 platform (Power Plate®, MY3, UK)off.
arm group label: Resistance & sham WBV
intervention type: Device
intervention name: WBV & resistance sham
description: used really the WBV, but sham for resistance training
For Resistance: performed similar movments in upper and lower limbs in weight machine Mega II Movement®, without using weights.
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.
arm group label: WBV & resistance sham
criteria: 
gender: All
minimum age: 60 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Maíra F Pessoa
investigator title: Principal Investigator