<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/NCT03280875</url>
  </required_header>
  <id_info>
    <org_study_id>Casillas ANR 2015</org_study_id>
    <nct_id>NCT03280875</nct_id>
  </id_info>
  <brief_title>Creation of an Algorithm for the Personalisation of Pedalling Exercises</brief_title>
  <acronym>EXOMODE</acronym>
  <official_title>Personalisation of Exercise by Muscle Modulation, Step 1: Construction and Validation of an Algorithm for Personalisation for Pedalling Exercises</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the EXO-MODE project is to develop an innovative algorithm for the personalisation&#xD;
      of Concentric and / or Eccentric training programmes adapted to the individual to improve the&#xD;
      efficiency and tolerance. This algorithm will make it possible to personalise trainings&#xD;
      programmes according to the different profiles of subjects, determined on the basis of their&#xD;
      personal characteristics (age, sex, comorbidities), their exercise capacity and muscle&#xD;
      performance, their level of motivation and their perception of the workload, and of the&#xD;
      principal objective of the training programme. The final goal is to develop a tool to allow&#xD;
      elderly populations to exercise more easily and more effectively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">May 13, 2021</completion_date>
  <primary_completion_date type="Actual">April 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preliminary phase: level of perception of effort dissociated from the pain felt</measure>
    <time_frame>through study phase completion, an average of 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1:level of pain measured by visual analog scale</measure>
    <time_frame>through study phase completion, an average of 9 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pedalling exercises</intervention_name>
    <description>pedalling exercises on a bicycle ergometer</description>
    <arm_group_label>healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject able to understand simple instructions and to provide consent&#xD;
&#xD;
          -  Men or women aged 18 to 75 years old.&#xD;
&#xD;
          -  Subjects who engage in moderate physical activity (Level 1 or 2 defined by the&#xD;
             recommendations for the classification of subjects during performance studies) [2].&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons without national health insurance cover,&#xD;
&#xD;
          -  Cardio-respiratory failure, coronaropathy, severe obstructive cardiomyopathy,&#xD;
&#xD;
          -  Recent history of venous thromboembolism (previous 3 months),&#xD;
&#xD;
          -  Any medical disorder that could have a major impact on functional capacities&#xD;
             (examples: non-stabilised metabolic disorders, such as progressive renal failure,&#xD;
             severe asthenia related to a non-stabilised disease, such as neoplasia, systemic&#xD;
             disease…),&#xD;
&#xD;
          -  Physical disability affecting the lower limbs or the pelvis that could impair or&#xD;
             prevent exercise on a cycle ergometer, whether neurological (central or peripheral),&#xD;
             arterial (i particular, arteriopathy of the lower limbs with a systolic index &lt; 0.6)&#xD;
             or orthopaedic (degenerative or inflammatory rheumatism).&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03280875
org study id: Casillas ANR 2015
nct id: NCT03280875
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the EXO-MODE project is to develop an innovative algorithm for the personalisation
      of Concentric and / or Eccentric training programmes adapted to the individual to improve the
      efficiency and tolerance. This algorithm will make it possible to personalise trainings
      programmes according to the different profiles of subjects, determined on the basis of their
      personal characteristics (age, sex, comorbidities), their exercise capacity and muscle
      performance, their level of motivation and their perception of the workload, and of the
      principal objective of the training programme. The final goal is to develop a tool to allow
      elderly populations to exercise more easily and more effectively.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Preliminary phase: level of perception of effort dissociated from the pain felt
time frame: through study phase completion, an average of 3 months
measure: Phase 1:level of pain measured by visual analog scale
time frame: through study phase completion, an average of 9 months
arm group label: healthy volunteers
arm group type: Experimental
intervention type: Other
intervention name: pedalling exercises
description: pedalling exercises on a bicycle ergometer
arm group label: healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor