<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/NCT02263573</url>
  </required_header>
  <id_info>
    <org_study_id>5830</org_study_id>
    <nct_id>NCT02263573</nct_id>
  </id_info>
  <brief_title>Effect of PEP'C-R on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70</brief_title>
  <acronym>PEP'C-R</acronym>
  <official_title>Effect of a New Training Protocol: the PEP'C With Constant Load and Intermittent Recovery (PEP'C-R), on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of the protocol is to determine the effects of a new program of PEP'C&#xD;
      &quot;PEP'C with constant load and intermittent recovery&quot; (PEP'C-R) on endurance parameters of&#xD;
      older seniors.&#xD;
&#xD;
      The study hypothesis: the investigators propose that PEP'C-R training offers a significant&#xD;
      improvement in endurance parameters for older seniors.&#xD;
&#xD;
      The secondary objectives are to determine the effects of PEP'C-R on maximal&#xD;
      cardio-respiratory function, FMD (Flow-mediated dilation), PWV (pulse wave velocity),&#xD;
      systolic and diastolic heart function, body composition (measured by impedance), biological,&#xD;
      functional and cognitive functioning and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    -  Interim analysis on 60 randomized subjects showed significant result for the main outcome&#xD;
         (VT1)&#xD;
&#xD;
      -  Enrollment difficulty&#xD;
  </why_stopped>
  <start_date type="Actual">December 4, 2014</start_date>
  <completion_date type="Actual">October 18, 2017</completion_date>
  <primary_completion_date type="Actual">October 18, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in intensity in W of the first ventilatory threshold (VT1)</measure>
    <time_frame>From baseline to 9.5 weeks</time_frame>
    <description>Determine the intensity in W of the first ventilatory threshold (VT1) for the experimental group and for the control group.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Sedentary Lifestyle in Patients Over 70</condition>
  <arm_group>
    <arm_group_label>PEP'C-R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will benefit from one preliminary session and 18 sessions of PEP'C-R, (2 sessions per week for 9.5 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEP'C-R</intervention_name>
    <description>Preliminary session of calibration and tolerance: Test of Borg: determination of VT1 for 10 minutes, 3 min pedaling at 25 W and then 20 minutes pedaling on VT1 determined during the exercise test (ET) -10%.&#xD;
Session 1: 30 min of pedaling at constant load VT1 determined during exercise testing (EE) - 10%.&#xD;
Session 2 Session 17: increase in the burden of BASE (5 BASE * 5 min: 25 min) by 10% and decrease in relation to the load of the PIC (5 PIC * 1 min: 5 min) to get a cumulative charge of the same session. Changes in heart rate (HR) determine the evolution of sustained loads: a decrease of 10 bpm in heart rate leads to an increase by 10% in the intensity of the base (PIC load remains constant).&#xD;
Session 18 = Session 1.</description>
    <arm_group_label>PEP'C-R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group usual activities</intervention_name>
    <description>Participants in the control group will not follow the intervention PEP'C-R. They will continue their usual activities for 9.5 weeks and will be assessed before and after this period. After the study, they will be offered the benefit of the conventional program of the PEP'C.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low physical activity determined using the questionnaire IPAQ in METs (&lt;3).&#xD;
&#xD;
          -  Informed about the results of examinations performed at screening visit.&#xD;
&#xD;
          -  Subject able to understand the purpose, procedures and risks of the study and give&#xD;
             written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to perform the cardiac stress test and PEP'C-R (Musculoskeletal&#xD;
             limitations, Unstabilized heart Failure with chest pain on exertion under maximal&#xD;
             medical therapy, ventricular and supraventricular disorders, Acute coronary syndrome&#xD;
             within &lt;1 month, Unstabilized respiratory failure or oxygen-dependent)&#xD;
&#xD;
          -  Abnormality shown at the cardiac stress test : clinical abnormality (chest pain),&#xD;
             electric abnormality (found on ECG), abnormal blood pressure, abnormality of the&#xD;
             ventilatory system (bronchospasm, hypoxemia,...)&#xD;
&#xD;
          -  Cognitive impairment which exclude PEP'C-R training.&#xD;
&#xD;
          -  Current Cancer chemotherapy.&#xD;
&#xD;
          -  Visual Impairment which exclude PEP'C-R training.&#xD;
&#xD;
          -  Presence of fibromyalgia.&#xD;
&#xD;
          -  Subject treated with beta-blockers and other negative chronotropic molecules.&#xD;
&#xD;
          -  Acute infection at the time of inclusion.&#xD;
&#xD;
          -  Dependent patient.&#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>Thomas VOGEL, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg Cedex</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PEP'C-R</keyword>
  <keyword>Endurance parameters</keyword>
  <keyword>Maximal cardio-respiratory function</keyword>
  <keyword>Older seniors</keyword>
  <keyword>Over 70</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/NCT02263573
org study id: 5830
nct id: NCT02263573
lead sponsor: 
has dmc: No
The primary purpose of the protocol is to determine the effects of a new program of PEP'C
      "PEP'C with constant load and intermittent recovery" (PEP'C-R) on endurance parameters of
      older seniors.

      The study hypothesis: the investigators propose that PEP'C-R training offers a significant
      improvement in endurance parameters for older seniors.

      The secondary objectives are to determine the effects of PEP'C-R on maximal
      cardio-respiratory function, FMD (Flow-mediated dilation), PWV (pulse wave velocity),
      systolic and diastolic heart function, body composition (measured by impedance), biological,
      functional and cognitive functioning and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in intensity in W of the first ventilatory threshold (VT1)
time frame: From baseline to 9.5 weeks
description: Determine the intensity in W of the first ventilatory threshold (VT1) for the experimental group and for the control group.
arm group label: PEP'C-R
arm group type: Experimental
description: Subjects will benefit from one preliminary session and 18 sessions of PEP'C-R, (2 sessions per week for 9.5 weeks).
arm group label: Control group
arm group type: Active Comparator
description: Subjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks.
intervention type: Other
intervention name: PEP'C-R
description: Preliminary session of calibration and tolerance: Test of Borg: determination of VT1 for 10 minutes, 3 min pedaling at 25 W and then 20 minutes pedaling on VT1 determined during the exercise test (ET) -10%.
Session 1: 30 min of pedaling at constant load VT1 determined during exercise testing (EE) - 10%.
Session 2 Session 17: increase in the burden of BASE (5 BASE * 5 min: 25 min) by 10% and decrease in relation to the load of the PIC (5 PIC * 1 min: 5 min) to get a cumulative charge of the same session. Changes in heart rate (HR) determine the evolution of sustained loads: a decrease of 10 bpm in heart rate leads to an increase by 10% in the intensity of the base (PIC load remains constant).
Session 18 = Session 1.
arm group label: PEP'C-R
intervention type: Other
intervention name: Control group usual activities
description: Participants in the control group will not follow the intervention PEP'C-R. They will continue their usual activities for 9.5 weeks and will be assessed before and after this period. After the study, they will be offered the benefit of the conventional program of the PEP'C.
arm group label: Control group
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas VOGEL, MD, PhD
role: Principal Investigator
affiliation: CHRU Strasbourg
facility: 
country: France
responsible party type: Sponsor