<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/NCT03299374</url>
  </required_header>
  <id_info>
    <org_study_id>Pilates _FB</org_study_id>
    <nct_id>NCT03299374</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Pilates Method to Prevent and Reduce Falls in Older People</brief_title>
  <official_title>Estudio Comparativo de Los Beneficios Del Método Pilates Frente a un Programa específico de prevención de caídas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</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>
      The present research aims at evidencing the effect of one of the training methodologies&#xD;
      increasingly demanded by the older adult, and used to promote, maintain and enhance physical&#xD;
      and biopsychosocial aspects. Consequently, we intend to base the evidence supporting Pilates&#xD;
      as an effective method in the following specific aspects: balance, prevention and reduction&#xD;
      of falls, and improvement of the quality of life in the older adult&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 15, 2018</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants are informed, so masking is not ensured Outcomes evaluator masked Physiotherapist none masked External adviser masked (randomization and data analysis)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Falls calendar</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Number of falls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale International</measure>
    <time_frame>change from baseline to end of intervention (4 month) and follow-up (1 year)</time_frame>
    <description>Risk of falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed UP and Go Test</measure>
    <time_frame>change from baseline to end of intervention (4 month) and follow-up (1 year)</time_frame>
    <description>Dynamic balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Reach Test</measure>
    <time_frame>change from baseline to end of intervention (4 month) and follow-up (1 year)</time_frame>
    <description>Stability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One Leg stance</measure>
    <time_frame>change from baseline to end of intervention (4 month) and follow-up (1 year)</time_frame>
    <description>Static Balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euro Quality of Life 5 Dimension</measure>
    <time_frame>change from baseline to end of intervention (4 month) and follow-up (1 year)</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Aging Problems</condition>
  <arm_group>
    <arm_group_label>Falls Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Falls prevention intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pilates Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pilates intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates Intervention</intervention_name>
    <description>Intervention based on Pilates principles</description>
    <arm_group_label>Pilates Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fall prevention intervention</intervention_name>
    <description>Intervention based on principles to prevent falls</description>
    <arm_group_label>Falls Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects +60 years.&#xD;
&#xD;
          -  Subjects without cognitive impairment that prevent from performing interventions. A&#xD;
             score in the Mini-Cognitive Examination of Lobo has to be equal or greater than 20&#xD;
             points.&#xD;
&#xD;
          -  Subjects without physical impairment that prevent from performing interventions, or&#xD;
             can directly influence the evaluation of the balance abilities (i.e., vestibular&#xD;
             pathologies, amputated limbs, etc.)&#xD;
&#xD;
          -  Subjects willing to participate, and have read, understood and signed an informed&#xD;
             consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose M Blasco, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Jose María Blasco Igual</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pilates</keyword>
  <keyword>Balance</keyword>
  <keyword>Falls</keyword>
  <keyword>Older people</keyword>
  <!-- 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/NCT03299374
org study id: Pilates _FB
nct id: NCT03299374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present research aims at evidencing the effect of one of the training methodologies
      increasingly demanded by the older adult, and used to promote, maintain and enhance physical
      and biopsychosocial aspects. Consequently, we intend to base the evidence supporting Pilates
      as an effective method in the following specific aspects: balance, prevention and reduction
      of falls, and improvement of the quality of life in the older adult
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Participants are informed, so masking is not ensured Outcomes evaluator masked Physiotherapist none masked External adviser masked (randomization and data analysis)
measure: Falls calendar
time frame: 1 year follow-up
description: Number of falls
measure: Falls Efficacy Scale International
time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
description: Risk of falls
measure: Timed UP and Go Test
time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
description: Dynamic balance
measure: Functional Reach Test
time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
description: Stability
measure: One Leg stance
time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
description: Static Balance
measure: Euro Quality of Life 5 Dimension
time frame: change from baseline to end of intervention (4 month) and follow-up (1 year)
description: Quality of life
arm group label: Falls Group
arm group type: Active Comparator
description: Falls prevention intervention
arm group label: Pilates Group
arm group type: Experimental
description: Pilates intervention
intervention type: Other
intervention name: Pilates Intervention
description: Intervention based on Pilates principles
arm group label: Pilates Group
intervention type: Other
intervention name: Fall prevention intervention
description: Intervention based on principles to prevent falls
arm group label: Falls Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jose M Blasco, PhD
role: Principal Investigator
affiliation: University of Valencia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Jose María Blasco Igual
investigator title: Principal Investigator