<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/NCT04504786</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-F(II)-20190045(1)</org_study_id>
    <nct_id>NCT04504786</nct_id>
  </id_info>
  <brief_title>Vitality Acupunch Exercise Program for Sarcopenia Older Adults</brief_title>
  <acronym>VA</acronym>
  <official_title>Effects of the Vitality Acupunch Exercise Program on the ADL and Functional Fitness of Sarcopenia Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University</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>
      This project was aimed to test the effects of a six-month VA program on the activities of&#xD;
      daily living (ADL) and functional fitness of institutional older adults with sarcopenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cluster-randomized controlled trial was conducted to test the effects of a six-month VA&#xD;
      program on ADL and functional fitness (lung capacity, body flexibility, range of the joint's&#xD;
      motion, and muscle endurance) of institutional older adults with sarcopenia. Using&#xD;
      convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and&#xD;
      then cluster-randomized by the facility to a VA experimental or a control group. The&#xD;
      experimental group received the VA program led by certified instructors 3 times per week and&#xD;
      40 minutes per session for six months; the control group continued with their regular daily&#xD;
      activities. One pre-test and two post-tests, three months apart, were conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Actual">March 6, 2021</completion_date>
  <primary_completion_date type="Actual">March 6, 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lung capacity</measure>
    <time_frame>6 months</time_frame>
    <description>measured by the TruZoneTM Peak Flow Meter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Upper body flexibility</measure>
    <time_frame>6 months</time_frame>
    <description>measured by the Back Scratch Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower body flexibility</measure>
    <time_frame>6 months</time_frame>
    <description>measured by the Chair Sit-and-Reach Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of joint motion</measure>
    <time_frame>6 months</time_frame>
    <description>measured by the goniometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm muscle endurance</measure>
    <time_frame>6 months</time_frame>
    <description>measured by the Arm Curl Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leg muscle endurance</measure>
    <time_frame>6 months</time_frame>
    <description>measured by the Chair-to-Stand Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activities of daily living (ADL)</measure>
    <time_frame>6 months</time_frame>
    <description>measured by the Barthel Index. The score of &quot;0-20&quot; means totally dependent; &quot;21-60&quot; means heavily dependent; &quot;61-90&quot; means moderately dependent; &quot;91-99&quot; means mildly dependent; &quot;100&quot; indicates total independence in the ADL of a person.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Activities of Daily Living</condition>
  <condition>Functional Fitness</condition>
  <arm_group>
    <arm_group_label>Vitality acupunch (VA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The VA program took 40 minutes to complete and included three phases: 1) activating qi and blood (5 movements, 10 minutes): warm-up exercises that allowed the body to accumulate heat and promote flexibility of the joints to loosen up the body, 2) punching meridians (14 movements, 20 minutes): both hands were used to exert a vibrating effect according to the rhythms that stimulate the 14 meridians in the entire body to improve aerobic endurance, and 3) relaxing body and mind (5 movements, 10 minutes): muscle relaxing exercises to rest the body and cease the qi. Participants in the experimental group received the VA program led by the instructors, who were trained and certified by the PI, 3 times per week and 40 minutes per session for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the control group continued with their daily activities as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vitality acupunch (VA) exercise program</intervention_name>
    <description>The VA had three phases and took 40 minutes to complete.</description>
    <arm_group_label>Vitality acupunch (VA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants maintained their daily activities.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 65 years old&#xD;
&#xD;
          -  have been living in the facility for at least three months&#xD;
&#xD;
          -  intact cognitive function with the Short Portable Mental Status Questionnaire (SPMSQ)&#xD;
             score ≥ 8&#xD;
&#xD;
          -  hand-grip strength &lt; 28 kg for men and &lt; 18 kg for women&#xD;
&#xD;
          -  calf circumference &lt; 34 cm for men and &lt; 33 cm for women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have spinal cord injury&#xD;
&#xD;
          -  have severe cardiovascular or pulmonary diseases&#xD;
&#xD;
          -  have musculoskeletal diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuei-Min Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Medical University</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80708</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Medical University</investigator_affiliation>
    <investigator_full_name>Kuei-Min Chen, Ph.D., RN.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <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/NCT04504786
org study id: KMUHIRB-F(II)-20190045(1)
nct id: NCT04504786
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project was aimed to test the effects of a six-month VA program on the activities of
      daily living (ADL) and functional fitness of institutional older adults with sarcopenia.
A cluster-randomized controlled trial was conducted to test the effects of a six-month VA
      program on ADL and functional fitness (lung capacity, body flexibility, range of the joint's
      motion, and muscle endurance) of institutional older adults with sarcopenia. Using
      convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and
      then cluster-randomized by the facility to a VA experimental or a control group. The
      experimental group received the VA program led by certified instructors 3 times per week and
      40 minutes per session for six months; the control group continued with their regular daily
      activities. One pre-test and two post-tests, three months apart, were conducted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Lung capacity
time frame: 6 months
description: measured by the TruZoneTM Peak Flow Meter
measure: Upper body flexibility
time frame: 6 months
description: measured by the Back Scratch Test
measure: Lower body flexibility
time frame: 6 months
description: measured by the Chair Sit-and-Reach Test
measure: Range of joint motion
time frame: 6 months
description: measured by the goniometry
measure: Arm muscle endurance
time frame: 6 months
description: measured by the Arm Curl Test
measure: Leg muscle endurance
time frame: 6 months
description: measured by the Chair-to-Stand Test
measure: Activities of daily living (ADL)
time frame: 6 months
description: measured by the Barthel Index. The score of "0-20" means totally dependent; "21-60" means heavily dependent; "61-90" means moderately dependent; "91-99" means mildly dependent; "100" indicates total independence in the ADL of a person.
arm group label: Vitality acupunch (VA)
arm group type: Experimental
description: The VA program took 40 minutes to complete and included three phases: 1) activating qi and blood (5 movements, 10 minutes): warm-up exercises that allowed the body to accumulate heat and promote flexibility of the joints to loosen up the body, 2) punching meridians (14 movements, 20 minutes): both hands were used to exert a vibrating effect according to the rhythms that stimulate the 14 meridians in the entire body to improve aerobic endurance, and 3) relaxing body and mind (5 movements, 10 minutes): muscle relaxing exercises to rest the body and cease the qi. Participants in the experimental group received the VA program led by the instructors, who were trained and certified by the PI, 3 times per week and 40 minutes per session for 6 months.
arm group label: Control
arm group type: Active Comparator
description: Participants in the control group continued with their daily activities as usual.
intervention type: Other
intervention name: Vitality acupunch (VA) exercise program
description: The VA had three phases and took 40 minutes to complete.
arm group label: Vitality acupunch (VA)
intervention type: Other
intervention name: Control
description: Participants maintained their daily activities.
arm group label: Control
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kuei-Min Chen, PhD
role: Principal Investigator
affiliation: Kaohsiung Medical University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Medical University
investigator full name: Kuei-Min Chen, Ph.D., RN.
investigator title: Professor
mesh term: Sarcopenia
sharing ipd: No