<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/NCT02214485</url>
  </required_header>
  <id_info>
    <org_study_id>201101038RC</org_study_id>
    <nct_id>NCT02214485</nct_id>
  </id_info>
  <brief_title>Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan</brief_title>
  <official_title>Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan</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>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To determine the differential effectiveness of integrated care (IC) and lower&#xD;
      extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.&#xD;
&#xD;
      Method: The investigators randomize participants at Bei-Hu site from the &quot;Intervention study&#xD;
      of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial&quot;&#xD;
      into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks&#xD;
      and 6 months after initiation of the interventions.&#xD;
&#xD;
      Interventions:&#xD;
&#xD;
        1. IC: Participants visit the study site with health education, social activities, warm up,&#xD;
           stretch, and low intensity resistance exercise for about 1 hour per week. If any medical&#xD;
           problems or functional decline suspected during the visit, the case manager refers&#xD;
           participants to their primary care physicians for further managements.&#xD;
&#xD;
        2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining&#xD;
           using isotonic strength training machines each week. The intensity is set at 60-80% of 1&#xD;
           repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks&#xD;
           for individualized adjustments&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">March 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>Single Group Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>leg extension power</measure>
    <time_frame>changes in 12 weeks</time_frame>
    <description>Leg extension power is to be measured at baseline, 12 weeks (after completion of intervention), and 6 months (after completion of the study). Specifically, following warm-up of three submaximal isotonic contractions, each subject was asked to extend his knee through a range of motions from -80 to -10 degrees of knee extension (0° extension being full knee extension without hyperextension) at an initial resistance equal to 25 percent of the subject's body weight. Knee range of motion was determined goniometrically. Following the successful completion of one full repetition, additional resistance of 1 kg, or a multiple thereof, was added. The repetition was repeated until the subject was no longer able to complete one full repetition. The number is the measured leg extension power</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>integrated care (IC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive such care twice weekly for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lower extremity strength training (LEST)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive training twice weekly for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>integrated care</intervention_name>
    <description>Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements.</description>
    <arm_group_label>integrated care (IC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lower extremity strength training</intervention_name>
    <description>Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments.</description>
    <arm_group_label>lower extremity strength training (LEST)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese&#xD;
             In-Person Interview Version score is 3-6&#xD;
&#xD;
          -  frailty index ≧ 1 (Cardiovascular Health Study Phenotypical Classification)。&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age ≧ 80 years&#xD;
&#xD;
          -  live in the nursing home.&#xD;
&#xD;
          -  can not speak Chinese,Taiwanese.&#xD;
&#xD;
          -  communication or hearing disorders affect daily activities.&#xD;
&#xD;
          -  visual impairment or daily activities affect communication.&#xD;
&#xD;
          -  another reason can not Communication or finish Canadian Study of Health and Aging&#xD;
             Clinical Frailty Scale (CSHA- CFS) Chinese In-Person Version&#xD;
&#xD;
          -  study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese In-Person&#xD;
             Interview [9, 10]Version score is 0-2 and 7.&#xD;
&#xD;
          -  communication or cognitive impairments affect daily activities(Exclusion 3-Item Recall&#xD;
             score is &lt;=1)&#xD;
&#xD;
          -  can not stand to walk (available walkers) 5 meters, or unsteady gait when walking five&#xD;
             meters, it looks fast fall&#xD;
&#xD;
          -  there is serious risk of suicide (defined as: Suicide risk assessment score&gt; = 6&#xD;
             points)&#xD;
&#xD;
          -  alcoholism (defined as: the problem of alcoholism Chinese people self-administered&#xD;
             screening questionnaire CAGE have two questions (including) above answer is &quot;yes&quot;&#xD;
&#xD;
          -  long-term epilepsy, brain tumor, brain surgery, schizophrenia or bipolar disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching-Yu Chen, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Family MedicineNational Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 30, 2013</study_first_submitted>
  <study_first_submitted_qc>August 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 10, 2014</last_update_submitted>
  <last_update_submitted_qc>August 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>frailty</keyword>
  <keyword>exercise</keyword>
  <keyword>intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</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/NCT02214485
org study id: 201101038RC
nct id: NCT02214485
lead sponsor: 
has dmc: No
Objective: To determine the differential effectiveness of integrated care (IC) and lower
      extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.

      Method: The investigators randomize participants at Bei-Hu site from the "Intervention study
      of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial"
      into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks
      and 6 months after initiation of the interventions.

      Interventions:

        1. IC: Participants visit the study site with health education, social activities, warm up,
           stretch, and low intensity resistance exercise for about 1 hour per week. If any medical
           problems or functional decline suspected during the visit, the case manager refers
           participants to their primary care physicians for further managements.

        2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining
           using isotonic strength training machines each week. The intensity is set at 60-80% of 1
           repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks
           for individualized adjustments
allocation: Randomized
intervention model: Single Group Assignment
masking: Single (Participant)
measure: leg extension power
time frame: changes in 12 weeks
description: Leg extension power is to be measured at baseline, 12 weeks (after completion of intervention), and 6 months (after completion of the study). Specifically, following warm-up of three submaximal isotonic contractions, each subject was asked to extend his knee through a range of motions from -80 to -10 degrees of knee extension (0° extension being full knee extension without hyperextension) at an initial resistance equal to 25 percent of the subject's body weight. Knee range of motion was determined goniometrically. Following the successful completion of one full repetition, additional resistance of 1 kg, or a multiple thereof, was added. The repetition was repeated until the subject was no longer able to complete one full repetition. The number is the measured leg extension power
arm group label: integrated care (IC)
arm group type: Experimental
description: Subjects will receive such care twice weekly for 12 weeks.
arm group label: lower extremity strength training (LEST)
arm group type: Experimental
description: Subjects will receive training twice weekly for 12 weeks
intervention type: Behavioral
intervention name: integrated care
description: Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements.
arm group label: integrated care (IC)
intervention type: Behavioral
intervention name: lower extremity strength training
description: Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments.
arm group label: lower extremity strength training (LEST)
criteria: 
gender: All
minimum age: 65 Years
maximum age: 79 Years
healthy volunteers: No
last name: Ching-Yu Chen, PHD
role: Study Chair
affiliation: Department of Family MedicineNational Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Frailty