<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/NCT03019211</url>
  </required_header>
  <id_info>
    <org_study_id>PrePhysFalls</org_study_id>
    <nct_id>NCT03019211</nct_id>
  </id_info>
  <brief_title>Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly</brief_title>
  <acronym>PrePhysFalls</acronym>
  <official_title>Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ramon Llull</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanitas Mayores Les Corts</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Residencial Augusta Park</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ramon Llull</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot randomized control trial with single blinding of the assessor that will be&#xD;
      conducted in two nursing homes residence to evaluate the applicability of a physical exercise&#xD;
      program performed in an aquatic environment compared with the same realization but land-based&#xD;
      to reduce falls in the institutionalized old people. The secondary objectives are to study&#xD;
      the applicability of the intervention in improving balance, function, gait mobility, muscle&#xD;
      strength of the lower limbs and the perception of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will be randomized and divided into the hydrotherapy group or the control&#xD;
      group. Each participant will attend a total of 24 physical exercise sessions of 50 minutes of&#xD;
      duration. The study outcomes will be measured before the intervention and in 3 posterior&#xD;
      phases to evaluate its effects in the short, medium and long terms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Number of Falls at 3 months, 6 months and 9 months</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
    <description>Falls follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Balance measured with Performance Oriented Mobility Assessment</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
    <description>Measured with Performance Oriented Mobility Assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain measured with Visual Analogue Scale</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
    <description>Measured with Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility measured with Timed Up &amp; Go Test</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
    <description>Measured with Timed Up &amp; Go Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily living activities measured with Barthel Test</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
    <description>Measured with Barthel Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength measured with Five Sit to Stand test and Handgrip Test</measure>
    <time_frame>3 months, 6 months, 9 months</time_frame>
    <description>Measured with Five Sit to Stand test and Handgrip Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Perception measured with Qualitative interview</measure>
    <time_frame>3 months</time_frame>
    <description>Qualitative interview</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Age Problems</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Elderly</condition>
  <condition>Postural Balance</condition>
  <condition>Strength</condition>
  <arm_group>
    <arm_group_label>Hydrotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise performed in an aquatic environment. The participants will perform static/dynamic exercises (balance and resistance training) in an aquatic environment. Training volume and intensity we will increase systematically over 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants will perform exercises (balance and resistance training) like hydrotherapy group but out of the aquatic environment, during a 12 weeks training period (3sessions/week). Training volume and intensity we will increase systematically over 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Hydrotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be institutionalized in a care center&#xD;
&#xD;
          -  Participate voluntarily and sign the informed consent&#xD;
&#xD;
          -  Have a punctuation of 2 or more in The Downton Fall Risk Index&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffer from a condition that can be affected or hinder exercise&#xD;
&#xD;
          -  Acute disease unresolved in 10 days&#xD;
&#xD;
          -  Not controlled hypertension&#xD;
&#xD;
          -  Contagious skin disorder&#xD;
&#xD;
          -  Urinary or faecal incontinence&#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>Mercè Sitjà Rabert, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ramon Llull</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitat Ramon Llull</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical Therapy Modalities</keyword>
  <keyword>Accidental Fall</keyword>
  <keyword>Elderly</keyword>
  <keyword>Hydrotherapy</keyword>
  <keyword>Nursing Home</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03019211
org study id: PrePhysFalls
nct id: NCT03019211
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a pilot randomized control trial with single blinding of the assessor that will be
      conducted in two nursing homes residence to evaluate the applicability of a physical exercise
      program performed in an aquatic environment compared with the same realization but land-based
      to reduce falls in the institutionalized old people. The secondary objectives are to study
      the applicability of the intervention in improving balance, function, gait mobility, muscle
      strength of the lower limbs and the perception of the intervention.
The participants will be randomized and divided into the hydrotherapy group or the control
      group. Each participant will attend a total of 24 physical exercise sessions of 50 minutes of
      duration. The study outcomes will be measured before the intervention and in 3 posterior
      phases to evaluate its effects in the short, medium and long terms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline Number of Falls at 3 months, 6 months and 9 months
time frame: 3 months, 6 months, 9 months
description: Falls follow up
measure: Balance measured with Performance Oriented Mobility Assessment
time frame: 3 months, 6 months, 9 months
description: Measured with Performance Oriented Mobility Assessment
measure: Pain measured with Visual Analogue Scale
time frame: 3 months, 6 months, 9 months
description: Measured with Visual Analogue Scale
measure: Mobility measured with Timed Up & Go Test
time frame: 3 months, 6 months, 9 months
description: Measured with Timed Up & Go Test
measure: Daily living activities measured with Barthel Test
time frame: 3 months, 6 months, 9 months
description: Measured with Barthel Test
measure: Muscle strength measured with Five Sit to Stand test and Handgrip Test
time frame: 3 months, 6 months, 9 months
description: Measured with Five Sit to Stand test and Handgrip Test
measure: Intervention Perception measured with Qualitative interview
time frame: 3 months
description: Qualitative interview
arm group label: Hydrotherapy
arm group type: Experimental
description: Exercise performed in an aquatic environment. The participants will perform static/dynamic exercises (balance and resistance training) in an aquatic environment. Training volume and intensity we will increase systematically over 12 weeks.
arm group label: Control
arm group type: Active Comparator
description: The participants will perform exercises (balance and resistance training) like hydrotherapy group but out of the aquatic environment, during a 12 weeks training period (3sessions/week). Training volume and intensity we will increase systematically over 12 weeks.
intervention type: Other
intervention name: Exercise
arm group label: Control
arm group label: Hydrotherapy
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mercè Sitjà Rabert, PhD, PT
role: Principal Investigator
affiliation: University Ramon Llull
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No