<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/NCT03302923</url>
  </required_header>
  <id_info>
    <org_study_id>2016-08</org_study_id>
    <secondary_id>2016-A00068-43</secondary_id>
    <nct_id>NCT03302923</nct_id>
  </id_info>
  <brief_title>Brisk Walking Study in Nursing Home Residents</brief_title>
  <official_title>Effects of Brisk Walking on Autonomic Nervous System Reactivation in Nursing Home Residents.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Mutualiste Chirurgicale de la Loire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital of Saint-Etienne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinique Mutualiste Chirurgicale de la Loire</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>
      It is well established that physical activity reduces the physiological effects of ageing.&#xD;
      Among them, the decrease of the autonomic nervous system activity (ANS) is associated with&#xD;
      the increase of cardiovascular events and sleep disorders occurence. It has been shown that&#xD;
      high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years&#xD;
      old. However, such trainings were done by old athletes used to train at intensities that&#xD;
      could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking&#xD;
      shall be defined to make it practicable for the many in convalescent homes. The investigators&#xD;
      hypothesize that long term brisk walking training could lead to reactivate ANS in people&#xD;
      living in convalescent homes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to compare the effects of a 9 month brisk walking training (1 time a&#xD;
      week or 3 times a week) on the ANS of nursing home residents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Anticipated">November 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SDNN value</measure>
    <time_frame>9 months</time_frame>
    <description>Standard deviation of all normal nocturnal RR intervals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability parameters</measure>
    <time_frame>9 months</time_frame>
    <description>Autonomic nervous system balance (RMSSD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability parameters</measure>
    <time_frame>9 months</time_frame>
    <description>Autonomic nervous system balance (LF/HF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability parameters</measure>
    <time_frame>9 months</time_frame>
    <description>Autonomic nervous system balance (Ptot)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baroreflex sensitivity (BRS)</measure>
    <time_frame>9 months</time_frame>
    <description>BRS slope variation measured at rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum oxygen uptake (VO2max)</measure>
    <time_frame>9 months</time_frame>
    <description>Cardiopulmonary exercise testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily physical activity</measure>
    <time_frame>9 months</time_frame>
    <description>Actimetry (Actigraph-GT3X)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily physical activity</measure>
    <time_frame>9 months</time_frame>
    <description>Adult physical activity questionnaire (APAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary periods</measure>
    <time_frame>9 months</time_frame>
    <description>Actimetry (Actigraph GT3X)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary periods</measure>
    <time_frame>9 months</time_frame>
    <description>Adult physical activity questionnaire (APAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular force</measure>
    <time_frame>9 months</time_frame>
    <description>Lower limbs maximum voluntary force test measured on force chair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular endurance</measure>
    <time_frame>9 months</time_frame>
    <description>Lower limbs endurance test measured on force chair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular volume gains</measure>
    <time_frame>9 months</time_frame>
    <description>Lower limbs muscular magnetic resonance imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasmatic dosages of inflammatory molecules</measure>
    <time_frame>9 months</time_frame>
    <description>CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasmatic dosages of inflammatory molecules</measure>
    <time_frame>9 months</time_frame>
    <description>TNF alpha</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasmatic dosages of inflammatory molecules</measure>
    <time_frame>9 months</time_frame>
    <description>IL 17</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive improvements</measure>
    <time_frame>9 months</time_frame>
    <description>Neuropsychological evaluation with a neuropsychologist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>9 months</time_frame>
    <description>SF-36 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Physical Activity</condition>
  <condition>Autonomic Nervous System Imbalance</condition>
  <arm_group>
    <arm_group_label>Brisk walking 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 time a week of 9 months brisk walking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brisk walking 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 times a week of 9 months brisk walking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No brisk walking session</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brisk walking</intervention_name>
    <description>Prospective randomized clinical trial with 2 intervention groups and 1 control group.</description>
    <arm_group_label>Brisk walking 1</arm_group_label>
    <arm_group_label>Brisk walking 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being over 60 years old&#xD;
&#xD;
          -  Living in a nursing home of Mutualité Française de la Loire, France&#xD;
&#xD;
          -  Being able to walk without human aid&#xD;
&#xD;
          -  Being able to speak and write French&#xD;
&#xD;
          -  Being inactive (less than 1 hours of physical activity per week)&#xD;
&#xD;
          -  Having a normal sinus rhythm&#xD;
&#xD;
          -  Being affiliated to the social welfare system&#xD;
&#xD;
          -  Signing the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having serious balance disorders&#xD;
&#xD;
          -  Suffering from cardiac or respiratory pathologies that contraindicate physical&#xD;
             activity&#xD;
&#xD;
          -  Serious comorbidities contraindicating physical activity&#xD;
&#xD;
          -  Diagnosed cardiac pathologies that prevent heart rate variability analysis: congestive&#xD;
             heart failure, cardiac pacemaker, implantable cardioverter defibrillator, serious&#xD;
             ventricular rhythm troubles, atrial fibrillation, atrial flutter.&#xD;
&#xD;
          -  Persons under legal protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David HUPIN, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Saint-Etienne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David HUPIN, MD, PhD</last_name>
    <phone>0477829109</phone>
    <phone_ext>+33</phone_ext>
    <email>david.hupin@chu-st-etienne.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>French Loire Mutuality</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claude MONTUY-COQUARD, Me</last_name>
      <phone>0477476309</phone>
      <phone_ext>+33</phone_ext>
      <email>CMontuyCoquard@mutualite-loire.com</email>
    </contact>
    <investigator>
      <last_name>Jean-Claude BARTHELEMY, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Frédéric ROCHE, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Léonard FEASSON, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pascal EDOUARD, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul CALMELS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe TERRAT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie-Christine DIANA, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thierry BUSSO, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Diana RIMAUD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nursing home residents</keyword>
  <keyword>Brisk walking</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/NCT03302923
org study id: 2016-08
secondary id: 2016-A00068-43
nct id: NCT03302923
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is well established that physical activity reduces the physiological effects of ageing.
      Among them, the decrease of the autonomic nervous system activity (ANS) is associated with
      the increase of cardiovascular events and sleep disorders occurence. It has been shown that
      high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years
      old. However, such trainings were done by old athletes used to train at intensities that
      could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking
      shall be defined to make it practicable for the many in convalescent homes. The investigators
      hypothesize that long term brisk walking training could lead to reactivate ANS in people
      living in convalescent homes.
The investigators aim to compare the effects of a 9 month brisk walking training (1 time a
      week or 3 times a week) on the ANS of nursing home residents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SDNN value
time frame: 9 months
description: Standard deviation of all normal nocturnal RR intervals
measure: Heart rate variability parameters
time frame: 9 months
description: Autonomic nervous system balance (RMSSD)
measure: Heart rate variability parameters
time frame: 9 months
description: Autonomic nervous system balance (LF/HF)
measure: Heart rate variability parameters
time frame: 9 months
description: Autonomic nervous system balance (Ptot)
measure: Baroreflex sensitivity (BRS)
time frame: 9 months
description: BRS slope variation measured at rest
measure: Maximum oxygen uptake (VO2max)
time frame: 9 months
description: Cardiopulmonary exercise testing
measure: Daily physical activity
time frame: 9 months
description: Actimetry (Actigraph-GT3X)
measure: Daily physical activity
time frame: 9 months
description: Adult physical activity questionnaire (APAQ)
measure: Sedentary periods
time frame: 9 months
description: Actimetry (Actigraph GT3X)
measure: Sedentary periods
time frame: 9 months
description: Adult physical activity questionnaire (APAQ)
measure: Muscular force
time frame: 9 months
description: Lower limbs maximum voluntary force test measured on force chair
measure: Muscular endurance
time frame: 9 months
description: Lower limbs endurance test measured on force chair
measure: Muscular volume gains
time frame: 9 months
description: Lower limbs muscular magnetic resonance imaging (MRI)
measure: Plasmatic dosages of inflammatory molecules
time frame: 9 months
description: CRP
measure: Plasmatic dosages of inflammatory molecules
time frame: 9 months
description: TNF alpha
measure: Plasmatic dosages of inflammatory molecules
time frame: 9 months
description: IL 17
measure: Cognitive improvements
time frame: 9 months
description: Neuropsychological evaluation with a neuropsychologist.
measure: Quality of life
time frame: 9 months
description: SF-36 questionnaire
arm group label: Brisk walking 1
arm group type: Experimental
description: 1 time a week of 9 months brisk walking
arm group label: Brisk walking 3
arm group type: Experimental
description: 3 times a week of 9 months brisk walking
arm group label: Control group
arm group type: No Intervention
description: No brisk walking session
intervention type: Behavioral
intervention name: Brisk walking
description: Prospective randomized clinical trial with 2 intervention groups and 1 control group.
arm group label: Brisk walking 1
arm group label: Brisk walking 3
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: David HUPIN, MD, PhD
role: Principal Investigator
affiliation: University Hospital of Saint-Etienne
last name: David HUPIN, MD, PhD
phone: 0477829109
phone ext: +33
email: david.hupin@chu-st-etienne.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No