<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/NCT02253732</url>
  </required_header>
  <id_info>
    <org_study_id>UEE-SAS</org_study_id>
    <nct_id>NCT02253732</nct_id>
  </id_info>
  <brief_title>Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism &amp; Cognitive Function: Role for Myokines &amp; miRNAs</brief_title>
  <acronym>Brain-Muscle</acronym>
  <official_title>Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism &amp; Cognitive Function: Role for Myokines &amp; miRNAs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Slovak Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Bratislava</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Slovak Academy of Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine specific changes in muscle secretory profile&#xD;
      (myokines, miRNA) in association with neurodegenerative disease progression and metabolic&#xD;
      dysfunction. Next the investigators would like to determine the shift in the muscle secretory&#xD;
      activity induced by regular exercise intervention, which the investigators think could be&#xD;
      translated into the beneficial changes in clinical phenotypes, determined by neuroimaging,&#xD;
      cognitive function tests and metabolic phenotyping.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard Operating Procedures for patient recruitment, data collection, data management, data&#xD;
      analysis routinely used in University Hospital Bratislava and in Institute of Experimental&#xD;
      Endocrinology Slovak Academy of Sciences will be employed.&#xD;
&#xD;
      Statistical analysis will be employed to address the primary and secondary objectives, as&#xD;
      specified in the study protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>muscle microRNAs and myokines</measure>
    <time_frame>up to 24 months</time_frame>
    <description>We will determine muscle bioactive secretory products (myokines &amp; miRNAs) that are regulated by acute bout of exercise in patients with neurodegenerative disease as well as in sedentary age, gender and BMI matched controls in association with their metabolic phenotype.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>whole body energy metabolism</measure>
    <time_frame>up to 24 months</time_frame>
    <description>changes in whole body energy metabolism will be determined with indirect calorimetry. &amp; oral glucose tolerance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cognitive function</measure>
    <time_frame>up to 24 months</time_frame>
    <description>exercise related changes in cognitive &amp; motoric functions will be determined with the aid of questionaires, and proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>motoric function</measure>
    <time_frame>up to 30 months</time_frame>
    <description>Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle functional tests</measure>
    <time_frame>up to 30 months</time_frame>
    <description>Dynamometry will be used to determine maximal voluntary contraction force and the rate of force development, and Phosphorus (31P)-magnetic resonance spectroscopy to measure muscle metabolism in vivo.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Alzheimer Disease</condition>
  <condition>Parkinson Disease</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>'3 months exercise intervention program'</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>all participants will be subjected to 3 months supervised exercise intervention programme</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>3 months exercise intervention program</intervention_name>
    <description>3 months exercise intervention program which is given 3-times per week, 60 min session duration, 65-75% repetition maximum or heart rate maximum, combined strength &amp; aerobic exercises</description>
    <arm_group_label>'3 months exercise intervention program'</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent.&#xD;
&#xD;
          2. Diagnosed with Parkinson disease&#xD;
&#xD;
          3. Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious systemic cardiovascular, hepatic, renal disease, cancer.&#xD;
&#xD;
          2. Lack of compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Valkovic, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Bratislava</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stanislav Sutovsky, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Bratislava</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy Hospital in Bratislava</name>
      <address>
        <city>Bratislava</city>
        <zip>81369</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inst. Exp. Endocrinology Slovak Acad Sci</name>
      <address>
        <city>Bratislava</city>
        <zip>83306</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovakia</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>April 14, 2018</last_update_submitted>
  <last_update_submitted_qc>April 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Slovak Academy of Sciences</investigator_affiliation>
    <investigator_full_name>Jozef Ukropec</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>MicroRNAs</keyword>
  <keyword>exercise</keyword>
  <keyword>skeletal muscle</keyword>
  <keyword>metabolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT02253732
org study id: UEE-SAS
nct id: NCT02253732
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine specific changes in muscle secretory profile
      (myokines, miRNA) in association with neurodegenerative disease progression and metabolic
      dysfunction. Next the investigators would like to determine the shift in the muscle secretory
      activity induced by regular exercise intervention, which the investigators think could be
      translated into the beneficial changes in clinical phenotypes, determined by neuroimaging,
      cognitive function tests and metabolic phenotyping.
Standard Operating Procedures for patient recruitment, data collection, data management, data
      analysis routinely used in University Hospital Bratislava and in Institute of Experimental
      Endocrinology Slovak Academy of Sciences will be employed.

      Statistical analysis will be employed to address the primary and secondary objectives, as
      specified in the study protocol.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: muscle microRNAs and myokines
time frame: up to 24 months
description: We will determine muscle bioactive secretory products (myokines & miRNAs) that are regulated by acute bout of exercise in patients with neurodegenerative disease as well as in sedentary age, gender and BMI matched controls in association with their metabolic phenotype.
measure: whole body energy metabolism
time frame: up to 24 months
description: changes in whole body energy metabolism will be determined with indirect calorimetry. & oral glucose tolerance test
measure: cognitive function
time frame: up to 24 months
description: exercise related changes in cognitive & motoric functions will be determined with the aid of questionaires, and proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy
measure: motoric function
time frame: up to 30 months
description: Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing
measure: Muscle functional tests
time frame: up to 30 months
description: Dynamometry will be used to determine maximal voluntary contraction force and the rate of force development, and Phosphorus (31P)-magnetic resonance spectroscopy to measure muscle metabolism in vivo.
arm group label: '3 months exercise intervention program'
arm group type: Experimental
description: all participants will be subjected to 3 months supervised exercise intervention programme
intervention type: Behavioral
intervention name: 3 months exercise intervention program
description: 3 months exercise intervention program which is given 3-times per week, 60 min session duration, 65-75% repetition maximum or heart rate maximum, combined strength & aerobic exercises
arm group label: '3 months exercise intervention program'
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Valkovic, MD, PhD
role: Study Chair
affiliation: University Hospital Bratislava
last name: Stanislav Sutovsky, MD, PhD
role: Study Chair
affiliation: University Hospital Bratislava
facility: 
facility: 
country: Slovakia
responsible party type: Principal Investigator
investigator affiliation: Slovak Academy of Sciences
investigator full name: Jozef Ukropec
investigator title: PhD
mesh term: Parkinson Disease
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction