<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/NCT01733303</url>
  </required_header>
  <id_info>
    <org_study_id>201003065R</org_study_id>
    <nct_id>NCT01733303</nct_id>
  </id_info>
  <brief_title>Fracture and Fall Prevention in Elderly With Osteoporosis</brief_title>
  <official_title>Fracture and Fall Prevention in Elderly With Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <brief_summary>
    <textblock>
      Osteoporosis is a prevalent health concern among older adults and is associated with an&#xD;
      increased risk of falls that can cause fracture, injury or mortality. Identifying the factors&#xD;
      related to falls occurring within this population is essential for the development of&#xD;
      effective regimes for fall prevention. Studies have shown that muscle quality and good&#xD;
      posture alignments are critical for balance control in older adults. People are diagnosed&#xD;
      with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading&#xD;
      vertebral, fractures and poor balance control, even falls. Therefore, improving muscle&#xD;
      quality, strengthening weak muscles and correcting postural alignment are essential elements&#xD;
      for fracture and fall prevention in older adults with osteoporosis. The long-term objectives&#xD;
      of this work are to prevent fracture and fall in older adults with osteoporosis by improving&#xD;
      the function of degenerative muscles using exercise training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of torque demand to capacity ratio 6 months</measure>
    <time_frame>Change from Baseline intorque demand to capacity ratio at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of torque demand to capacity ratio at 3 months</measure>
    <time_frame>Change from Baseline in torque demand to capacity ratio at 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of torque demand to capacity ratio at 12months</measure>
    <time_frame>Change from Baseline in torque demand to capacity ratio at 12 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>personalized core muscle training program</intervention_name>
    <description>Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality. The program will run for 3 months with patients attending for one hour three times a week. The age-matched control group will maintain their usual daily life activities without any specific instruction. The exercise training will be run by an experienced physiotherapist, who will encourage patients individually to progress at their own pace.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criteria for osteopenia or osteoporosis group:&#xD;
&#xD;
          1. able to stand and walk for 5 minutes independently;&#xD;
&#xD;
          2. having normal or corrected to normal vision;&#xD;
&#xD;
          3. having age between &gt; 50 years&#xD;
&#xD;
          4. with osteopenia (-2.5 &lt; t-score &lt; -1.0) or osteoporosis (t-score &lt;-2.5).&#xD;
&#xD;
        The exclusion criteria for osteopenia or osteoporosis group:&#xD;
&#xD;
          1. being pregnant;&#xD;
&#xD;
          2. sensory-motor deficits;&#xD;
&#xD;
          3. inability of communication&#xD;
&#xD;
          4. lack of access to a telephone.&#xD;
&#xD;
        The inclusion criteria for control age-matched group:&#xD;
&#xD;
          1. able to stand and walk for 5 minutes independently;&#xD;
&#xD;
          2. having normal or corrected to normal vision;&#xD;
&#xD;
          3. having age between &gt; 50 years&#xD;
&#xD;
          4. without osteopenia or osteoporosis (t-score &gt; -1.0).&#xD;
&#xD;
        The exclusion criteria for control age-matched group:&#xD;
&#xD;
          1. being pregnant;&#xD;
&#xD;
          2. sensory-motor deficits;&#xD;
&#xD;
          3. inability of communication&#xD;
&#xD;
          4. lack of access to a telephone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weili Hsu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weili Hsu, PhD</last_name>
    <phone>886-2-3366-8127</phone>
    <email>wlhsu@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10055</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weili Hsu, PhD</last_name>
      <phone>886-2-3366-8127</phone>
      <email>wlhsu@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</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/NCT01733303
org study id: 201003065R
nct id: NCT01733303
lead sponsor: 
Osteoporosis is a prevalent health concern among older adults and is associated with an
      increased risk of falls that can cause fracture, injury or mortality. Identifying the factors
      related to falls occurring within this population is essential for the development of
      effective regimes for fall prevention. Studies have shown that muscle quality and good
      posture alignments are critical for balance control in older adults. People are diagnosed
      with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading
      vertebral, fractures and poor balance control, even falls. Therefore, improving muscle
      quality, strengthening weak muscles and correcting postural alignment are essential elements
      for fracture and fall prevention in older adults with osteoporosis. The long-term objectives
      of this work are to prevent fracture and fall in older adults with osteoporosis by improving
      the function of degenerative muscles using exercise training.
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes of torque demand to capacity ratio 6 months
time frame: Change from Baseline intorque demand to capacity ratio at 6 months
measure: Changes of torque demand to capacity ratio at 3 months
time frame: Change from Baseline in torque demand to capacity ratio at 3 months
measure: Change of torque demand to capacity ratio at 12months
time frame: Change from Baseline in torque demand to capacity ratio at 12 months
arm group label: Exercise
arm group type: Experimental
description: Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality.
intervention type: Behavioral
intervention name: personalized core muscle training program
description: Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality. The program will run for 3 months with patients attending for one hour three times a week. The age-matched control group will maintain their usual daily life activities without any specific instruction. The exercise training will be run by an experienced physiotherapist, who will encourage patients individually to progress at their own pace.
arm group label: Exercise
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Weili Hsu, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Weili Hsu, PhD
phone: 886-2-3366-8127
email: wlhsu@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Osteoporosis