<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/NCT04481438</url>
  </required_header>
  <id_info>
    <org_study_id>201900696B0</org_study_id>
    <nct_id>NCT04481438</nct_id>
  </id_info>
  <brief_title>Effects of Acupunch Exercises on the Frail Older Adults in Long-Term Care Facilities</brief_title>
  <official_title>Effects of Acupunch Exercises on the Frail Older Adults in Long-Term Care Facilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      Frailty is a complex elderly problem and a precursor of functional degradation in elder&#xD;
      adults. The aim of this study will to test the effects of acupunch exercises on the frail&#xD;
      older adults in long-term care facilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Frailty is a complex elderly problem and a precursor of functional degradation in elder&#xD;
      adults. The cause of frailty is multifactorial. Regular exercise intervension could improve&#xD;
      frailty condition and general functional fitness. The acupunch exercise program was developed&#xD;
      based on Jing-Luo theory of tranditional Chinese Medicine. The aim of this study will to test&#xD;
      the effects of acupunch exercises on the frail older adults in long-term care facilities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 24, 2020</start_date>
  <completion_date type="Actual">March 24, 2021</completion_date>
  <primary_completion_date type="Actual">March 24, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>handgrip strength</measure>
    <time_frame>24 weeks</time_frame>
    <description>handgrip strength measured by the Digital Handgrip Dynamometer (in kilograms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>upper limb muscle endurance</measure>
    <time_frame>24 weeks</time_frame>
    <description>upper limb muscle endurance measured by the Arm Curl Test in times per 30 seconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lower limb muscle endurance</measure>
    <time_frame>24 weeks</time_frame>
    <description>lower limb muscle endurance measured by the Chair-to-Stand Test in times per 30 seconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lung function</measure>
    <time_frame>24 weeks</time_frame>
    <description>lung function measured by Peak Flow Meter (in liters)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>upper body flexibility</measure>
    <time_frame>24 weeks</time_frame>
    <description>upper body flexibility measured by the Back Scratch Test( in centimeters)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>forward flexion</measure>
    <time_frame>24 weeks</time_frame>
    <description>forward flexion measured by the Chair Sit-and-Reach Test( in centimeters)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>shoulder joint flexion</measure>
    <time_frame>24 weeks</time_frame>
    <description>shoulder joint flexion measured by protractor( in degree)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>shoulder joint abduction</measure>
    <time_frame>24 weeks</time_frame>
    <description>shoulder joint abduction measured by protractor( in degree)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>frailty status</measure>
    <time_frame>24 weeks</time_frame>
    <description>evaluated based on the guidelines of the SOF Research Group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Frailty</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exercise group will receive acupunch exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group will maintain the regular activities of their original daily lives</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupunch Exercises</intervention_name>
    <description>The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The experiment group will receive Acupunch exercise for 40 minute sessions, 3 times a week, for 24 weeks</description>
    <arm_group_label>exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  frail older adults&#xD;
&#xD;
          -  aged 65 and above&#xD;
&#xD;
          -  had lived in the long-term care facilities more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dementia patient&#xD;
&#xD;
          -  psychiatric patient&#xD;
&#xD;
          -  spinal cord injury patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chia-Pei Chou, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elderly Care Center</name>
      <address>
        <city>Renwu</city>
        <state>Kaohsiung City</state>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Citizens' Home</name>
      <address>
        <city>Yanchao</city>
        <state>Kaohsiung City</state>
        <zip>824</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Conservation Center</name>
      <address>
        <city>Daliao</city>
        <state>Kaohsiung</state>
        <zip>831</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elderly Care Center</name>
      <address>
        <city>Fengshan</city>
        <state>Kaohsiung</state>
        <zip>830</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nursing Home</name>
      <address>
        <city>Gangshan</city>
        <state>Kaohsiung</state>
        <zip>820</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nursing Home</name>
      <address>
        <city>Sanmin</city>
        <state>Kaohsiung</state>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nursing Home</name>
      <address>
        <city>Pingtung</city>
        <state>Pingtung City</state>
        <zip>900</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nursing Home</name>
      <address>
        <city>Chaozhou</city>
        <state>Pingtung</state>
        <zip>920</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nursing Home</name>
      <address>
        <city>Pingtung</city>
        <zip>900</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senior Citizens' Home</name>
      <address>
        <city>Pingtung</city>
        <zip>900</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Hsiao CY, Chen KM, Tsai HY, Huang HT, Cheng YY, Tsai AY. Self-Perceived Health and Sleep Quality of Community Older Adults after Acupunch Exercises. Am J Geriatr Psychiatry. 2018 May;26(5):511-520. doi: 10.1016/j.jagp.2018.01.199. Epub 2018 Jan 31.</citation>
    <PMID>29433845</PMID>
  </results_reference>
  <results_reference>
    <citation>Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.</citation>
    <PMID>26255709</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chia-Pei Chou</investigator_full_name>
    <investigator_title>Medical doctor, Family Medicine Department</investigator_title>
  </responsible_party>
  <keyword>Acupunch exercises</keyword>
  <keyword>Frailty</keyword>
  <keyword>long-term care facilities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>for personal privacy reason</ipd_description>
  </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/NCT04481438
org study id: 201900696B0
nct id: NCT04481438
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Frailty is a complex elderly problem and a precursor of functional degradation in elder
      adults. The aim of this study will to test the effects of acupunch exercises on the frail
      older adults in long-term care facilities.
Frailty is a complex elderly problem and a precursor of functional degradation in elder
      adults. The cause of frailty is multifactorial. Regular exercise intervension could improve
      frailty condition and general functional fitness. The acupunch exercise program was developed
      based on Jing-Luo theory of tranditional Chinese Medicine. The aim of this study will to test
      the effects of acupunch exercises on the frail older adults in long-term care facilities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: handgrip strength
time frame: 24 weeks
description: handgrip strength measured by the Digital Handgrip Dynamometer (in kilograms)
measure: upper limb muscle endurance
time frame: 24 weeks
description: upper limb muscle endurance measured by the Arm Curl Test in times per 30 seconds
measure: lower limb muscle endurance
time frame: 24 weeks
description: lower limb muscle endurance measured by the Chair-to-Stand Test in times per 30 seconds
measure: lung function
time frame: 24 weeks
description: lung function measured by Peak Flow Meter (in liters)
measure: upper body flexibility
time frame: 24 weeks
description: upper body flexibility measured by the Back Scratch Test( in centimeters)
measure: forward flexion
time frame: 24 weeks
description: forward flexion measured by the Chair Sit-and-Reach Test( in centimeters)
measure: shoulder joint flexion
time frame: 24 weeks
description: shoulder joint flexion measured by protractor( in degree)
measure: shoulder joint abduction
time frame: 24 weeks
description: shoulder joint abduction measured by protractor( in degree)
measure: frailty status
time frame: 24 weeks
description: evaluated based on the guidelines of the SOF Research Group
arm group label: exercise group
arm group type: Experimental
description: exercise group will receive acupunch exercise
arm group label: control group
arm group type: No Intervention
description: control group will maintain the regular activities of their original daily lives
intervention type: Other
intervention name: Acupunch Exercises
description: The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The experiment group will receive Acupunch exercise for 40 minute sessions, 3 times a week, for 24 weeks
arm group label: exercise group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chia-Pei Chou, MD
role: Study Chair
affiliation: Chang Gung Memorial Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
citation: Hsiao CY, Chen KM, Tsai HY, Huang HT, Cheng YY, Tsai AY. Self-Perceived Health and Sleep Quality of Community Older Adults after Acupunch Exercises. Am J Geriatr Psychiatry. 2018 May;26(5):511-520. doi: 10.1016/j.jagp.2018.01.199. Epub 2018 Jan 31.
PMID: 29433845
citation: Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.
PMID: 26255709
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Chia-Pei Chou
investigator title: Medical doctor, Family Medicine Department
mesh term: Frailty
sharing ipd: No
ipd description: for personal privacy reason