<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/NCT03759977</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01833</org_study_id>
    <nct_id>NCT03759977</nct_id>
  </id_info>
  <brief_title>Effects of an Adapted Physical Activity on the Postural Control of Residents in Nursing Home.</brief_title>
  <official_title>Effects of Adapted Physical Activity on the Static and Dynamic Postural Control of Residents in Nursing Home: an Exploratory Study of 8 Weeks in the Réseau Santé de la Glâne (Canton of Fribourg, Switzerland).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne</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 study measures the effects of an Adapted Physical Activity on postural control of&#xD;
      residents in nursing home. Half of participants will follow a program training 3 times a week&#xD;
      during 8 weeks, while the other half will receive the usual accompaniment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">March 22, 2019</completion_date>
  <primary_completion_date type="Actual">March 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>pre- posttest with control group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postural control</measure>
    <time_frame>15 minutes</time_frame>
    <description>Measures of the center of pressure under different conditions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Habitual gait speed in meter per seconde</measure>
    <time_frame>5 minutes</time_frame>
    <description>Gait parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait variability in percentage</measure>
    <time_frame>5 minutes</time_frame>
    <description>Gait parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait asymmetry in percentage</measure>
    <time_frame>5 minutes</time_frame>
    <description>Gait parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery test</measure>
    <time_frame>10 minutes</time_frame>
    <description>This unique test is composed of a standing balance exercise, a gait speed exercise and chair stand exercise. It gives a score of 0 to 12. 0 is the worst performance and 12 the best one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General quality of life</measure>
    <time_frame>5 minutes</time_frame>
    <description>Euro Quality of life 5 dimensions (EQ-5D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>5 minutes</time_frame>
    <description>Geriatric Depression Scale 4 items. 0 (the best) to 4 (the worst) points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of falling</measure>
    <time_frame>5 minutes</time_frame>
    <description>Falls Efficacy Scale International. 7 (no concern about falling) to 28 (severe concern about falling)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Postural Control</condition>
  <arm_group>
    <arm_group_label>Adapted Physical Activity group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive 3 sessions per week of specific physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual accompaniment group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will continue to follow the usual accompaniment of the nursing home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adapted Physical Activity</intervention_name>
    <description>The sessions of Adapted Physical Activity will be focus around the theme of balance, with a small part of resistance training.</description>
    <arm_group_label>Adapted Physical Activity group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to walk 20 meters with or without auxiliary help&#xD;
&#xD;
          -  Able to stand 1 minute without help&#xD;
&#xD;
          -  Health status considered stable&#xD;
&#xD;
          -  Life expectancy greater than 6 months&#xD;
&#xD;
          -  No major cognitive impairment preventing them from understanding a simple instruction&#xD;
&#xD;
          -  No severe visual impairment&#xD;
&#xD;
          -  No severe deafness&#xD;
&#xD;
          -  Understanding french&#xD;
&#xD;
          -  Able to discern&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to walk 20 meters with or without auxiliary help&#xD;
&#xD;
          -  Unable to stand 1 minute without help&#xD;
&#xD;
          -  Health status considered unstable&#xD;
&#xD;
          -  Estimated life expectancy at less than 6 months&#xD;
&#xD;
          -  Major cognitive impairment preventing them from understanding a simple instruction&#xD;
&#xD;
          -  Severe visual impairment&#xD;
&#xD;
          -  Severe deafness&#xD;
&#xD;
          -  Not understanding french&#xD;
&#xD;
          -  Inability to discern&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Gremeaux, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Université de Lausanne</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne</investigator_affiliation>
    <investigator_full_name>Thomas Bugnon</investigator_full_name>
    <investigator_title>Student</investigator_title>
  </responsible_party>
  <keyword>adapted physical activity</keyword>
  <keyword>nursing home</keyword>
  <keyword>elderly</keyword>
  <keyword>postural control</keyword>
  <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/NCT03759977
org study id: 2018-01833
nct id: NCT03759977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study measures the effects of an Adapted Physical Activity on postural control of
      residents in nursing home. Half of participants will follow a program training 3 times a week
      during 8 weeks, while the other half will receive the usual accompaniment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: pre- posttest with control group
primary purpose: Prevention
masking: None (Open Label)
measure: Postural control
time frame: 15 minutes
description: Measures of the center of pressure under different conditions.
measure: Habitual gait speed in meter per seconde
time frame: 5 minutes
description: Gait parameter
measure: Gait variability in percentage
time frame: 5 minutes
description: Gait parameter
measure: Gait asymmetry in percentage
time frame: 5 minutes
description: Gait parameter
measure: Short Physical Performance Battery test
time frame: 10 minutes
description: This unique test is composed of a standing balance exercise, a gait speed exercise and chair stand exercise. It gives a score of 0 to 12. 0 is the worst performance and 12 the best one.
measure: General quality of life
time frame: 5 minutes
description: Euro Quality of life 5 dimensions (EQ-5D)
measure: Depression
time frame: 5 minutes
description: Geriatric Depression Scale 4 items. 0 (the best) to 4 (the worst) points.
measure: Fear of falling
time frame: 5 minutes
description: Falls Efficacy Scale International. 7 (no concern about falling) to 28 (severe concern about falling)
arm group label: Adapted Physical Activity group
arm group type: Experimental
description: This group will receive 3 sessions per week of specific physical activity.
arm group label: Usual accompaniment group
arm group type: No Intervention
description: This group will continue to follow the usual accompaniment of the nursing home.
intervention type: Other
intervention name: Adapted Physical Activity
description: The sessions of Adapted Physical Activity will be focus around the theme of balance, with a small part of resistance training.
arm group label: Adapted Physical Activity group
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vincent Gremeaux, Professor
role: Principal Investigator
affiliation: University of Lausanne
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne
investigator full name: Thomas Bugnon
investigator title: Student
sharing ipd: No