<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/NCT01734083</url>
  </required_header>
  <id_info>
    <org_study_id>HSEARS20120929006</org_study_id>
    <nct_id>NCT01734083</nct_id>
  </id_info>
  <brief_title>Whole Body Vibration Exercise for Elderly With Cognitive Impairments</brief_title>
  <official_title>The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Community-dwelling Elderly With Cognitive Impairments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The whole body vibration exercise group will have significantly more improvement in mobility,&#xD;
      muscle strength, balance, balance confidence, and cognitive function with a lower fall rate&#xD;
      than the control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timed-up-and-go test</measure>
    <time_frame>week 0</time_frame>
    <description>A measure of functional mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed-up-and-go test</measure>
    <time_frame>week 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed-up-and-go test</measure>
    <time_frame>week 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>week 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>week 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>week 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific balance confidence scale</measure>
    <time_frame>week 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific balance confidence scale</measure>
    <time_frame>week 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific balance confidence scale</measure>
    <time_frame>week 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>five times sit-to-stand test</measure>
    <time_frame>week 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>five times sit-to-stand test</measure>
    <time_frame>week 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>five times sit-to-stand test</measure>
    <time_frame>week 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination</measure>
    <time_frame>week 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination</measure>
    <time_frame>week 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination</measure>
    <time_frame>week 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Alzheimer's disease</measure>
    <time_frame>week 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Alzheimer's disease</measure>
    <time_frame>week 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Alzheimer's disease</measure>
    <time_frame>week 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of falls</measure>
    <time_frame>daily starting from week 0 to week 33</time_frame>
    <description>Incidence of falls will be recorded by using fall diaries.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Whole body vibration exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will receive 2 sessions of whole body vibration exercise training and conventional exercise per week for a period of 9 weeks. The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration frequency and amplitude used will be 30 Hz and 1 mm, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Whole body vibration exercise</intervention_name>
    <description>The whole body vibration will be delivered by a platform that can generate vibration signals (Powerplate). The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration bouts (30-45 seconds per bout) will be interspersed with a 1 to 2 minutes of rest period. While standing on the vibration platform, subjects will be instructed to repeat two exercises: (1) static semi-squats, and (2) dynamic semi-squats.</description>
    <arm_group_label>Whole body vibration exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional exercise</intervention_name>
    <description>The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.</description>
    <arm_group_label>Conventional exercise</arm_group_label>
    <arm_group_label>Whole body vibration exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a diagnosis of mild or moderate dementia, with a Clinical Dementia Rating (CDR) of 1&#xD;
             to 2, and a Cantonese Mini-mental State Examination (CMMSE) score at 10 or above but&#xD;
             below the local cutoff for dementia (18-22, depending on education level)&#xD;
&#xD;
          -  able to stand for at least 1 minute with or without hand support&#xD;
&#xD;
          -  living in the community&#xD;
&#xD;
          -  having an informed consent (from the primary caregiver)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant musculoskeletal conditions (e.g. amputations)&#xD;
&#xD;
          -  metal implants in the lower extremity&#xD;
&#xD;
          -  recent fracture in the lower extremity&#xD;
&#xD;
          -  vestibular disorders&#xD;
&#xD;
          -  peripheral vascular disease&#xD;
&#xD;
          -  other serious illnesses or contraindications to exercise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Pang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marco Pang, PhD</last_name>
    <phone>852-2766-7156</phone>
    <email>Marco.Pang@polyu.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jockey Club Centre for Positive Ageing</name>
      <address>
        <city>Shatin</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Timothy Kwok, MD</last_name>
      <phone>852-2636-6323</phone>
      <email>tkwok@cuhk.edu.hk</email>
    </contact>
    <investigator>
      <last_name>Timothy Kwok, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.</citation>
    <PMID>16372905</PMID>
  </reference>
  <reference>
    <citation>Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.</citation>
    <PMID>15706558</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Marco Yiu-Chung Pang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>exercise</keyword>
  <keyword>fall</keyword>
  <keyword>muscle</keyword>
  <keyword>vibration</keyword>
  <keyword>mobility</keyword>
  <keyword>cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT01734083
org study id: HSEARS20120929006
nct id: NCT01734083
lead sponsor: 
collaborator: 
has dmc: Yes
The whole body vibration exercise group will have significantly more improvement in mobility,
      muscle strength, balance, balance confidence, and cognitive function with a lower fall rate
      than the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Timed-up-and-go test
time frame: week 0
description: A measure of functional mobility
measure: Timed-up-and-go test
time frame: week 9
measure: Timed-up-and-go test
time frame: week 21
measure: Berg balance scale
time frame: week 0
measure: Berg balance scale
time frame: week 9
measure: Berg balance scale
time frame: week 21
measure: Activities-specific balance confidence scale
time frame: week 0
measure: Activities-specific balance confidence scale
time frame: week 9
measure: Activities-specific balance confidence scale
time frame: week 21
measure: five times sit-to-stand test
time frame: week 0
measure: five times sit-to-stand test
time frame: week 9
measure: five times sit-to-stand test
time frame: week 21
measure: Mini-Mental State Examination
time frame: week 0
measure: Mini-Mental State Examination
time frame: week 9
measure: Mini-Mental State Examination
time frame: week 21
measure: Quality of Life in Alzheimer's disease
time frame: week 0
measure: Quality of Life in Alzheimer's disease
time frame: week 9
measure: Quality of Life in Alzheimer's disease
time frame: week 21
measure: incidence of falls
time frame: daily starting from week 0 to week 33
description: Incidence of falls will be recorded by using fall diaries.
arm group label: Whole body vibration exercise
arm group type: Experimental
description: The experimental group will receive 2 sessions of whole body vibration exercise training and conventional exercise per week for a period of 9 weeks. The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration frequency and amplitude used will be 30 Hz and 1 mm, respectively.
arm group label: Conventional exercise
arm group type: Active Comparator
description: This group will receive 2 sessions of conventional exercise training per week for a period of 9 weeks.
intervention type: Device
intervention name: Whole body vibration exercise
description: The whole body vibration will be delivered by a platform that can generate vibration signals (Powerplate). The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration bouts (30-45 seconds per bout) will be interspersed with a 1 to 2 minutes of rest period. While standing on the vibration platform, subjects will be instructed to repeat two exercises: (1) static semi-squats, and (2) dynamic semi-squats.
arm group label: Whole body vibration exercise
intervention type: Behavioral
intervention name: Conventional exercise
description: The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.
arm group label: Conventional exercise
arm group label: Whole body vibration exercise
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Marco Pang, PhD
role: Principal Investigator
affiliation: Hong Kong Polytechnic University
last name: Marco Pang, PhD
phone: 852-2766-7156
email: Marco.Pang@polyu.edu.hk
facility: 
status: Recruiting
contact: 
investigator: 
country: Hong Kong
citation: Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.
PMID: 16372905
citation: Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
PMID: 15706558
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Marco Yiu-Chung Pang
investigator title: Associate Professor
mesh term: Cognitive Dysfunction