<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/NCT04438876</url>
  </required_header>
  <id_info>
    <org_study_id>GERI1618</org_study_id>
    <nct_id>NCT04438876</nct_id>
  </id_info>
  <brief_title>The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore</brief_title>
  <official_title>The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geriatric Education and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Geriatric Education and Research Institute</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>
      To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail&#xD;
      and frail community-dwelling older adults in Singapore for the management of physical&#xD;
      frailty. The proposed study will provide information on the benefits of FPT on physical&#xD;
      performances of older adults and help to shape future exercise recommendations to slow or&#xD;
      reverse the onset and severity of physical frailty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Frail status at 12 and 24 weeks</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Cardiovascular Health Study (CHS) Frailty status which characterizes frailty based on five components: unintentional weight loss, weakness, slowness, exhaustion and low physical activity. 1 point for each category. Robust: 0 point, Pre-Frail: 1-2 points , Frail: 3-5 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of hand grip strength at 12 and 24 weeks</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Hand grip strength (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of knee extensor strength at 12 and 24 weeks</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Knee extensor strength (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Timed up and go (TUG) at 12 and 24 weeks</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Timed up and go (TUG) (seconds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of SPPB at 12 and 24 weeks</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Short Physical Performance Battery (SPPB) consist of:&#xD;
Balance test&#xD;
Gait speed&#xD;
Chair stand test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise adherence</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Exercise journals</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Frailty</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Function power training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-week structured FPT program, conducted by a certified trainer from a community service provider. Sessions were held twice weekly at the respective community senior activity centers, each lasting 60 minutes in duration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Power Training</intervention_name>
    <description>The exercise intervention encompassed high-velocity movement, balance, and mobility exercises with the use of body weight and resistance bands as resistance. Participants were instructed to move rapidly during the concentric phase and slowly during the eccentric phase when performing the dynamic exercises.</description>
    <arm_group_label>Function power training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 55 years and above&#xD;
&#xD;
          -  low muscle strength - handgrip strength less than 26kg for men and 18kg for women&#xD;
&#xD;
          -  ambulate without human assistance&#xD;
&#xD;
          -  able to understand basic instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently enrolled in another study&#xD;
&#xD;
          -  acute musculoskeletal injury&#xD;
&#xD;
          -  unable to participate in the full duration of the study&#xD;
&#xD;
          -  unwilling to participate if not assigned to the intervention group&#xD;
&#xD;
          -  deemed not suitable to participate in exercise by a medical doctor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiou-Liang Wee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geriatric Education &amp; Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geriatric Education &amp; Research Institute</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</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>Muscle Weakness</mesh_term>
    <mesh_term>Frailty</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/NCT04438876
org study id: GERI1618
nct id: NCT04438876
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail
      and frail community-dwelling older adults in Singapore for the management of physical
      frailty. The proposed study will provide information on the benefits of FPT on physical
      performances of older adults and help to shape future exercise recommendations to slow or
      reverse the onset and severity of physical frailty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change of Frail status at 12 and 24 weeks
time frame: baseline, 12 weeks, 24 weeks
description: Cardiovascular Health Study (CHS) Frailty status which characterizes frailty based on five components: unintentional weight loss, weakness, slowness, exhaustion and low physical activity. 1 point for each category. Robust: 0 point, Pre-Frail: 1-2 points , Frail: 3-5 points.
measure: Change of hand grip strength at 12 and 24 weeks
time frame: baseline, 12 weeks, 24 weeks
description: Hand grip strength (kg)
measure: Change of knee extensor strength at 12 and 24 weeks
time frame: baseline, 12 weeks, 24 weeks
description: Knee extensor strength (kg)
measure: Change of Timed up and go (TUG) at 12 and 24 weeks
time frame: baseline, 12 weeks, 24 weeks
description: Timed up and go (TUG) (seconds)
measure: Change of SPPB at 12 and 24 weeks
time frame: baseline, 12 weeks, 24 weeks
description: Short Physical Performance Battery (SPPB) consist of:
Balance test
Gait speed
Chair stand test
measure: Exercise adherence
time frame: baseline, 12 weeks, 24 weeks
description: Exercise journals
arm group label: Function power training
arm group type: Experimental
description: 12-week structured FPT program, conducted by a certified trainer from a community service provider. Sessions were held twice weekly at the respective community senior activity centers, each lasting 60 minutes in duration.
arm group label: Usual care
arm group type: Active Comparator
description: Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.
intervention type: Other
intervention name: Functional Power Training
description: The exercise intervention encompassed high-velocity movement, balance, and mobility exercises with the use of body weight and resistance bands as resistance. Participants were instructed to move rapidly during the concentric phase and slowly during the eccentric phase when performing the dynamic exercises.
arm group label: Function power training
intervention type: Other
intervention name: Usual care
description: Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.
arm group label: Usual care
criteria: 
gender: All
minimum age: 55 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shiou-Liang Wee, PhD
role: Principal Investigator
affiliation: Geriatric Education & Research Institute
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Frailty
sharing ipd: No