<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/NCT03253042</url>
  </required_header>
  <id_info>
    <org_study_id>DL2017</org_study_id>
    <nct_id>NCT03253042</nct_id>
  </id_info>
  <brief_title>Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly</brief_title>
  <official_title>Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</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 purpose of this study is to analyze the immediate and chronic effects of an exercise&#xD;
      protocol on the vibration platform on the functional and neuromuscular performance of lower&#xD;
      limbs, postural control and life quality in healthy elderly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research is a randomized controlled trial that will be developed at the Laboratório de&#xD;
      Análise da Performance Muscular (LAPERN) of the Physiotherapy Department of the Federal&#xD;
      University of Rio Grande do Norte (UFRN). The population of the present study will be formed&#xD;
      by elderly individuals living in the city of Natal / RN, aged between 65 and 75 years, of&#xD;
      both sexes, without distinction of race, education and marital status. The research sample&#xD;
      will be of a non-probabilistic type, in which these will be allocated randomly into two&#xD;
      distinct groups: placebo group (GP) and experimental group (GE). This research was submitted&#xD;
      to the Research Ethics Committee (CEP) for UFRN through the national interface Plataforma&#xD;
      Brasil. The present research contemplates the ethical aspects based on Resolution 466/2012 of&#xD;
      the National Health Council (CNS) and the Declaration of Helsinki for research with humans.&#xD;
      In addition, the survey will be recorded in Clinicals Trial. All data will be recorded in a&#xD;
      database of the laboratory under confidentiality and can only be handled by the responsible&#xD;
      researchers. The study will only begin after the issuance of the referent opinion approving&#xD;
      the project. All subjects will be duly informed and instructed regarding the scheduled&#xD;
      procedures, which will only be executed after reading, accepting and signing the Term of Free&#xD;
      and Informed Consent (TFIC). After approval by the Research Ethics Committee, following&#xD;
      resolution 466/2012, a pilot study was carried out aiming at the adequacy of all the research&#xD;
      procedures, as well as the training of the researchers involved. Initially the research will&#xD;
      begin with the selection of the sample according to the inclusion criteria descried&#xD;
      elsewhere. The evaluation will be scheduled by telephone contact. Following this, the&#xD;
      volunteers will receive the TFIC for reading and due signature. The data collection process&#xD;
      will take place in four stages: (1) initial evaluation, (2) sample allocation (3) application&#xD;
      of exercise program and (4) reevaluations. The evaluations will be composed by the&#xD;
      dynamometric analysis associated with EMG (electromyography), functional performance and&#xD;
      postural control analysis. The volunteers will be allocated randomly into 2 groups: placebo&#xD;
      group (with the platform off) or experimental group (with the platform set at a frequency of&#xD;
      40 Hz and amplitude of 4 mm). Both will participate in a program of exercises in the&#xD;
      platform, consisting of a static bipodal squat at 40 ° of knee flexion, with 4 sets of 1.5&#xD;
      min, with a rest interval of 1 minute. Immediately after the first session, 4 and 8 weeks of&#xD;
      training, the volunteers will be submitted to the new evaluations, with the same procedures&#xD;
      of the initial evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Muscle Performance measured through isokinetic dynamometer</measure>
    <time_frame>Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.</time_frame>
    <description>The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, average power, total work and time to peak torque.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle activation measured through surface electromyography</measure>
    <time_frame>Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.</time_frame>
    <description>Measured by surface electromyography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balance measured through baropodometry</measure>
    <time_frame>Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.</time_frame>
    <description>Measured by baropodometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life measured through SF-36 questionnaire</measure>
    <time_frame>Baseline, after 4 and 8 weeks of the beginning of exercise program.</time_frame>
    <description>measured by SF-36 questionnaire score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional mobility measured through Timed up and Go test</measure>
    <time_frame>Baseline, after 4 and 8 weeks of the beginning of exercise program.</time_frame>
    <description>measured by Timed up and Go test time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Neuromuscular Performance and Balance</condition>
  <arm_group>
    <arm_group_label>WBV exercise program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week exercise program associated with the vibratory platform. Each exercise session will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will be connected at the beginning of each series, set at a vibration frequency of 40 Hertz (Hz) and peak-to-peak amplitude of 4 millimeters (mm) resulting in a peak acceleration of 128 ms2 (12.8 g). This should provide the equivalent of 3600 vertical vibrations, totaling 14400 vibrations per training session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham WBV exercise program</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>8-week exercise program in which each session will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WBV exercise program</intervention_name>
    <description>The intervention will consist of a 8-week whole-body vibration exercise program with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected.</description>
    <arm_group_label>WBV exercise program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham WBV exercise program</intervention_name>
    <description>The intervention will consist of a 8-week exercise program, but the platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.</description>
    <arm_group_label>Sham WBV exercise program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders;&#xD;
&#xD;
          -  Exhibiting ankle, hip and knee joint integrity of the non-dominant limb;&#xD;
&#xD;
          -  No history of muscle or joint injuries in the assessed limb in the last 6 months, or&#xD;
             neurological, visual and/or non-corrected auditory impairments;&#xD;
&#xD;
          -  Do not have metallic implants in the lower limbs;&#xD;
&#xD;
          -  Do not have decompensated and / or untreated cardiovascular diseases;&#xD;
&#xD;
          -  Do not have advanced osteoporosis;&#xD;
&#xD;
          -  Do not have neurodegenerative diseases;&#xD;
&#xD;
          -  Do not have vestibular disorders;&#xD;
&#xD;
          -  Do not have uncorrected visual or hearing deficits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elderly classified as very active or active;&#xD;
&#xD;
          -  Report cardiac and / or respiratory discomfort, nausea, vertigo and pain during during&#xD;
             the evaluations and exercise sessions;&#xD;
&#xD;
          -  Do not understand and do not correctly perform the commands offered in the assessment&#xD;
             and / or intervention protocols;&#xD;
&#xD;
          -  Miss 2 consecutive sessions during the exercise program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel T Borges, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio Grande do Norte</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lidiane C Correia, Esp</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio Grande do Norte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Rio Grande do Norte (UFRN)</name>
      <address>
        <city>Natal</city>
        <state>RN</state>
        <zip>59140-840</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>June 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Jamilson Simões Brasileiro</investigator_full_name>
    <investigator_title>Associeted Professor and Researcher</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Vibration</keyword>
  <keyword>Torque</keyword>
  <keyword>Aging</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/NCT03253042
org study id: DL2017
nct id: NCT03253042
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to analyze the immediate and chronic effects of an exercise
      protocol on the vibration platform on the functional and neuromuscular performance of lower
      limbs, postural control and life quality in healthy elderly.
The research is a randomized controlled trial that will be developed at the Laboratório de
      Análise da Performance Muscular (LAPERN) of the Physiotherapy Department of the Federal
      University of Rio Grande do Norte (UFRN). The population of the present study will be formed
      by elderly individuals living in the city of Natal / RN, aged between 65 and 75 years, of
      both sexes, without distinction of race, education and marital status. The research sample
      will be of a non-probabilistic type, in which these will be allocated randomly into two
      distinct groups: placebo group (GP) and experimental group (GE). This research was submitted
      to the Research Ethics Committee (CEP) for UFRN through the national interface Plataforma
      Brasil. The present research contemplates the ethical aspects based on Resolution 466/2012 of
      the National Health Council (CNS) and the Declaration of Helsinki for research with humans.
      In addition, the survey will be recorded in Clinicals Trial. All data will be recorded in a
      database of the laboratory under confidentiality and can only be handled by the responsible
      researchers. The study will only begin after the issuance of the referent opinion approving
      the project. All subjects will be duly informed and instructed regarding the scheduled
      procedures, which will only be executed after reading, accepting and signing the Term of Free
      and Informed Consent (TFIC). After approval by the Research Ethics Committee, following
      resolution 466/2012, a pilot study was carried out aiming at the adequacy of all the research
      procedures, as well as the training of the researchers involved. Initially the research will
      begin with the selection of the sample according to the inclusion criteria descried
      elsewhere. The evaluation will be scheduled by telephone contact. Following this, the
      volunteers will receive the TFIC for reading and due signature. The data collection process
      will take place in four stages: (1) initial evaluation, (2) sample allocation (3) application
      of exercise program and (4) reevaluations. The evaluations will be composed by the
      dynamometric analysis associated with EMG (electromyography), functional performance and
      postural control analysis. The volunteers will be allocated randomly into 2 groups: placebo
      group (with the platform off) or experimental group (with the platform set at a frequency of
      40 Hz and amplitude of 4 mm). Both will participate in a program of exercises in the
      platform, consisting of a static bipodal squat at 40 ° of knee flexion, with 4 sets of 1.5
      min, with a rest interval of 1 minute. Immediately after the first session, 4 and 8 weeks of
      training, the volunteers will be submitted to the new evaluations, with the same procedures
      of the initial evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Muscle Performance measured through isokinetic dynamometer
time frame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
description: The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, average power, total work and time to peak torque.
measure: Change in Muscle activation measured through surface electromyography
time frame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
description: Measured by surface electromyography
measure: Change in Balance measured through baropodometry
time frame: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
description: Measured by baropodometry
measure: Change in Quality of life measured through SF-36 questionnaire
time frame: Baseline, after 4 and 8 weeks of the beginning of exercise program.
description: measured by SF-36 questionnaire score
measure: Change in Functional mobility measured through Timed up and Go test
time frame: Baseline, after 4 and 8 weeks of the beginning of exercise program.
description: measured by Timed up and Go test time
arm group label: WBV exercise program
arm group type: Experimental
description: 8-week exercise program associated with the vibratory platform. Each exercise session will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will be connected at the beginning of each series, set at a vibration frequency of 40 Hertz (Hz) and peak-to-peak amplitude of 4 millimeters (mm) resulting in a peak acceleration of 128 ms2 (12.8 g). This should provide the equivalent of 3600 vertical vibrations, totaling 14400 vibrations per training session.
arm group label: Sham WBV exercise program
arm group type: Sham Comparator
description: 8-week exercise program in which each session will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.
intervention type: Other
intervention name: WBV exercise program
description: The intervention will consist of a 8-week whole-body vibration exercise program with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected.
arm group label: WBV exercise program
intervention type: Other
intervention name: Sham WBV exercise program
description: The intervention will consist of a 8-week exercise program, but the platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.
arm group label: Sham WBV exercise program
criteria: 
gender: All
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel T Borges, MD
role: Principal Investigator
affiliation: Universidade Federal do Rio Grande do Norte
last name: Lidiane C Correia, Esp
role: Principal Investigator
affiliation: Universidade Federal do Rio Grande do Norte
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Jamilson Simões Brasileiro
investigator title: Associeted Professor and Researcher
sharing ipd: No