<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/NCT02968875</url>
  </required_header>
  <id_info>
    <org_study_id>15/B/03</org_study_id>
    <nct_id>NCT02968875</nct_id>
  </id_info>
  <brief_title>Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training</brief_title>
  <acronym>MARAE</acronym>
  <official_title>Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common&#xD;
      forms of dementia in humans and memory disorder is one of the first symptoms that lead to&#xD;
      diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Present in greater amounts in the regions of the hippocampus and cortex, the Brain-derived&#xD;
      neurotrophic factor (BDNF) is essential to both learning and memory processes. This protein&#xD;
      is found in lower amounts in people with AD. Acute physical activity of moderate to vigorous&#xD;
      intensity would increase the levels of plasma BDNF whether for a healthy person or a person&#xD;
      with AD. Nevertheless in rest, healthy people have higher level of BDNF than individuals with&#xD;
      AD. There are no studies on the effect of chronic exercise based on BDNF level at rest in&#xD;
      people with AD. In a hypothetical endurance training of 18 sessions, whether interval or&#xD;
      continuous training the levels of BDNF would increase in people with AD at rest. Their&#xD;
      physiological and neuropsychological performances would also show a rise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.</measure>
    <time_frame>Up to 4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measuring the effect of training on the psychological performance by using questionnaire MMSE</measure>
    <time_frame>Up to 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)</measure>
    <time_frame>Up to 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)</measure>
    <time_frame>Up to 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress test</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress test</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Measuring the effect of training on the physiological performance by determining the grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the effect of training on the physiological performance with a walk test of 6 minutes.</measure>
    <time_frame>Up to 4 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Endurance Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The first group of 40 people will do endurance training; 20 of them will perform a continuous exercise on cycle ergometer at a power equivalent to 70% of the maximal heart rate, twice a week. The other group will do Interval Training, with a four minute long base and one minute long peak, twice a week. The base workload will be equivalent to an intensity of 60% of the maximal heart rate and the peak will be equivalent to 80% of the maximal heart rate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endurance Training</intervention_name>
    <description>40 people will submitted to endurance training: 20 will perform a continuous training and 20 will perform an interval training. The variables that will be analyzed are maximum aerobic power, endurance, heart rate, prehension strength, Mini-Mental State Examination (MMSE), REY's test, biological examination and level of BDNF plasma, before and after the intervention and one month after the end of the intervention and one month after the end of the intervention.</description>
    <arm_group_label>Endurance Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>therapeutic education meetings</intervention_name>
    <description>Group of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alzheimer's disease patients diagnosed by a consultation memory (DSM- IV)&#xD;
&#xD;
          -  Person with at least 60 years&#xD;
&#xD;
          -  Person with a score higher than 15 in the Mini Mental State Examination&#xD;
&#xD;
          -  No one can achieve the pedaling motion&#xD;
&#xD;
          -  People who do not perform regular physical activity on bike&#xD;
&#xD;
          -  Nobody has given free and informed consent in writing or obtained from a trusted&#xD;
             person or the family environment&#xD;
&#xD;
          -  People affiliated to a social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who refused to provide written consent&#xD;
&#xD;
          -  Inability to pedal&#xD;
&#xD;
          -  Recent myocardial necrosis (less than 3 months)&#xD;
&#xD;
          -  Aortic Stenosis&#xD;
&#xD;
          -  Uncompensated heart failure&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Ventricular arrythmia&#xD;
&#xD;
          -  Pulmonary embolism&#xD;
&#xD;
          -  Coxarthrosis, knee, ankle osteoarthritis&#xD;
&#xD;
          -  Not affiliated to a social security&#xD;
&#xD;
          -  Patient already participating in another biomedical research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Luc Ms FANON, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>May 24, 2018</last_update_submitted>
  <last_update_submitted_qc>May 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endurance training</keyword>
  <keyword>BDNF analysis</keyword>
  <keyword>cognitive function</keyword>
  <keyword>physiological abilities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT02968875
org study id: 15/B/03
nct id: NCT02968875
lead sponsor: 
has dmc: No
Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common
      forms of dementia in humans and memory disorder is one of the first symptoms that lead to
      diagnosis.
Present in greater amounts in the regions of the hippocampus and cortex, the Brain-derived
      neurotrophic factor (BDNF) is essential to both learning and memory processes. This protein
      is found in lower amounts in people with AD. Acute physical activity of moderate to vigorous
      intensity would increase the levels of plasma BDNF whether for a healthy person or a person
      with AD. Nevertheless in rest, healthy people have higher level of BDNF than individuals with
      AD. There are no studies on the effect of chronic exercise based on BDNF level at rest in
      people with AD. In a hypothetical endurance training of 18 sessions, whether interval or
      continuous training the levels of BDNF would increase in people with AD at rest. Their
      physiological and neuropsychological performances would also show a rise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
time frame: Up to 4 months
measure: Measuring the effect of training on the psychological performance by using questionnaire MMSE
time frame: Up to 4 months
measure: Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)
time frame: Up to 4 months
measure: Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)
time frame: Up to 4 months
measure: Stress test
time frame: Up to 4 months
description: Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated
measure: Stress test
time frame: Up to 4 months
description: Measuring the effect of training on the physiological performance by determining the grip strength
measure: Measuring the effect of training on the physiological performance with a walk test of 6 minutes.
time frame: Up to 4 months
arm group label: Endurance Training
arm group type: Active Comparator
description: The first group of 40 people will do endurance training; 20 of them will perform a continuous exercise on cycle ergometer at a power equivalent to 70% of the maximal heart rate, twice a week. The other group will do Interval Training, with a four minute long base and one minute long peak, twice a week. The base workload will be equivalent to an intensity of 60% of the maximal heart rate and the peak will be equivalent to 80% of the maximal heart rate.
arm group label: Control group
arm group type: Active Comparator
description: 20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings.
intervention type: Device
intervention name: Endurance Training
description: 40 people will submitted to endurance training: 20 will perform a continuous training and 20 will perform an interval training. The variables that will be analyzed are maximum aerobic power, endurance, heart rate, prehension strength, Mini-Mental State Examination (MMSE), REY's test, biological examination and level of BDNF plasma, before and after the intervention and one month after the end of the intervention and one month after the end of the intervention.
arm group label: Endurance Training
intervention type: Other
intervention name: therapeutic education meetings
description: Group of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Luc Ms FANON, Doctor
role: Principal Investigator
affiliation: CHU de Martinique
facility: 
country: Martinique
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No