<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/NCT02218411</url>
  </required_header>
  <id_info>
    <org_study_id>CEU UCH</org_study_id>
    <nct_id>NCT02218411</nct_id>
  </id_info>
  <brief_title>Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults.</brief_title>
  <official_title>Effectiveness of a Video-supported Group-based Otago Exercise Programme on Physical Performance in Community-dwelling Older Adults: a Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardenal Herrera University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardenal Herrera University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the effects of a video-supported group-based Otago&#xD;
      exercise programme intervention on balance, mobility, physical performance and aerobic&#xD;
      endurance in community-dwelling older adults 65+ years old.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Timed Up and Go test</measure>
    <time_frame>Pre intervention and after 4-month intervention</time_frame>
    <description>General mobility measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Berg Balance Scale</measure>
    <time_frame>Pre intervention and after 4-month intervention</time_frame>
    <description>Functional Balance measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the 6.min Walk Test</measure>
    <time_frame>Pre intervention and after 4-month intervention</time_frame>
    <description>Aerobic Endurance Measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the One-Leg Stand</measure>
    <time_frame>Pre intervention and after 4-month intervention</time_frame>
    <description>One-leg Balance Measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Short Physical Performance Battery</measure>
    <time_frame>Pre intervention and after 4-month intervention</time_frame>
    <description>Lower Limb Functional Measurement</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Healthy Aging</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercises routine based on the Otago exercise programme</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <description>Exercises routine based on the Otago exercise programme</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 65 years and older.&#xD;
&#xD;
          -  Living in the community (Valencia, Spain).&#xD;
&#xD;
          -  Able to ambulate independently without a walking aid.&#xD;
&#xD;
          -  Have no severe medical contraindication for physical activity.&#xD;
&#xD;
          -  Able to communicate.&#xD;
&#xD;
          -  Have self-reported visual and auditory capacities to follow commands.&#xD;
&#xD;
          -  Provide signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to ambulate independently.&#xD;
&#xD;
          -  Mini-mental state examination score of &lt;24.&#xD;
&#xD;
          -  Barthel Index score of &lt;80.&#xD;
&#xD;
          -  Severe visual and auditory disabilities.&#xD;
&#xD;
          -  Unstable cardiovascular disease.&#xD;
&#xD;
          -  Neurological disorder that could compromise them from exercising.&#xD;
&#xD;
          -  Upper or lower extremity fracture in the past year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vicent Benavent-Caballer, PT, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>CEU UCH</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardenal Herrera University</investigator_affiliation>
    <investigator_full_name>Eva Segura Ortí</investigator_full_name>
    <investigator_title>Effectiveness of a video-supported group-based Otago exercise programme on physical performance in community-dwelling older adults: a pilot randomized controlled trial</investigator_title>
  </responsible_party>
  <!-- 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/NCT02218411
org study id: CEU UCH
nct id: NCT02218411
lead sponsor: 
has dmc: Yes
The purpose of this study was to evaluate the effects of a video-supported group-based Otago
      exercise programme intervention on balance, mobility, physical performance and aerobic
      endurance in community-dwelling older adults 65+ years old.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in the Timed Up and Go test
time frame: Pre intervention and after 4-month intervention
description: General mobility measurement
measure: Change in the Berg Balance Scale
time frame: Pre intervention and after 4-month intervention
description: Functional Balance measurement
measure: Change in the 6.min Walk Test
time frame: Pre intervention and after 4-month intervention
description: Aerobic Endurance Measurement
measure: Change in the One-Leg Stand
time frame: Pre intervention and after 4-month intervention
description: One-leg Balance Measurement
measure: Change in the Short Physical Performance Battery
time frame: Pre intervention and after 4-month intervention
description: Lower Limb Functional Measurement
arm group label: Exercise
arm group type: Experimental
description: Exercises routine based on the Otago exercise programme
intervention type: Other
intervention name: Exercise training
description: Exercises routine based on the Otago exercise programme
arm group label: Exercise
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vicent Benavent-Caballer, PT, MS
role: Principal Investigator
affiliation: CEU UCH
responsible party type: Principal Investigator
investigator affiliation: Cardenal Herrera University
investigator full name: Eva Segura Ortí
investigator title: Effectiveness of a video-supported group-based Otago exercise programme on physical performance in community-dwelling older adults: a pilot randomized controlled trial