<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/NCT03245216</url>
  </required_header>
  <id_info>
    <org_study_id>DSN-032017</org_study_id>
    <nct_id>NCT03245216</nct_id>
  </id_info>
  <brief_title>Facilitating Motor Skill Learning in Parkinson's Disease</brief_title>
  <acronym>FAST-PD</acronym>
  <official_title>Facilitating Motor Skill Learning by Aerobic Training in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Foundation for Neurology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Erlangen-Nürnberg</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>
      The study is designed to assess the effects of aerobic exercise on motor learning in&#xD;
      Parkinson patients. Specifically, the investigators examine whether a single bout of moderate&#xD;
      intensity aerobic exercise, performed immediately before task practice, facilitates the&#xD;
      acquisition and retention of a motor skill. In a cross-over design, participants will be&#xD;
      randomly allocated to either the intervention group (aerobic exercise before motor learning)&#xD;
      or control group (rest before motor learning).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's disease is a progressive neurodegenerative disorder that is characterized by&#xD;
      motor control impairments, such as gait disturbances and postural instability. Beneficial&#xD;
      effects of exercise are attributed to mechanisms of neuroplasticity, and task-specific motor&#xD;
      training is consequently considered to be a motor learning process. While motor learning is&#xD;
      preserved in persons with Parkinson's disease, slower acquisition rates and reduced retention&#xD;
      have been reported compared to healthy individuals.&#xD;
&#xD;
      Thus, it is crucial to identify strategies to enhance motor learning in people with&#xD;
      Parkinson's disease. Recent studies have accumulated evidence to show that aerobic exercise&#xD;
      can facilitate motor skill learning. However, these observations are limited to healthy&#xD;
      individuals and have not been addressed in individuals with neurologic conditions.&#xD;
&#xD;
      The present study is designed to assess the effects of a single bout of moderate intensity&#xD;
      aerobic exercise on a motor skill learning task in patients with Parkinson's disease.&#xD;
&#xD;
      In a cross-over design, participants will be randomly allocated to one of two groups. Both&#xD;
      groups will practice balancing on a specific stability platform (motor learning task). The&#xD;
      experimental group will additionally perform a bout of aerobic exercise (cycle ergometer)&#xD;
      immediately before the motor learning task, while the control group will rest before&#xD;
      practice. Subsequently, the acquisition and one-day retention of the motor learning task will&#xD;
      be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor Learning (Precision)</measure>
    <time_frame>Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).</time_frame>
    <description>Change from baseline in time in balance (±5° from horizontal) during balancing task.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor Learning (Variability)</measure>
    <time_frame>Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).</time_frame>
    <description>Change from baseline in mean standard deviation (root mean square error) of platform deflection (in degree).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>aerobic exercise + motor skill practice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>acute bout of aerobic exercise before motor learning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rest + motor skill practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>seated rest before motor learning</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>aerobic exercise</intervention_name>
    <description>Single-bout of moderate intensity aerobic exercise on a cycle ergometer before motor learning</description>
    <arm_group_label>aerobic exercise + motor skill practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>rest</intervention_name>
    <description>Seated rest before motor learning</description>
    <arm_group_label>rest + motor skill practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>motor learning</intervention_name>
    <description>Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in an horizontal position.</description>
    <arm_group_label>aerobic exercise + motor skill practice</arm_group_label>
    <arm_group_label>rest + motor skill practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease stage 1-3 on Hoehn &amp; Yahr scale&#xD;
&#xD;
          -  Ability to stand unaided and walk without an assistive device&#xD;
&#xD;
          -  Stable medication during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On-off and wearing-off phenomena&#xD;
&#xD;
          -  Unstable medical or psychiatric illness&#xD;
&#xD;
          -  Clinically relevant cardiovascular or orthopaedic disease&#xD;
&#xD;
          -  Severe polyneuropathy&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Smoking &gt; 10 cigarettes/day&#xD;
&#xD;
          -  Caffeine &gt; 6 cups of coffee/day&#xD;
&#xD;
          -  Alcohol &gt; 50 g (two glasses)/day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Steib, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b</name>
      <address>
        <city>Erlangen</city>
        <zip>91058</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.sport.fau.de/lehrstuehle-und-fachgebiete/bewegung-und-gesundheit/forschungsprojekte/optimierung-motorischer-lernprozesse-in-der-rehabilitation-von-parkinsonpatienten/</url>
    <description>project webpage</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg</investigator_affiliation>
    <investigator_full_name>Simon Steib, PhD</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>motor learning</keyword>
  <keyword>aerobic exercise</keyword>
  <keyword>cardiovascular exercise</keyword>
  <keyword>balance</keyword>
  <keyword>postural instability</keyword>
  <keyword>motor skill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03245216
org study id: DSN-032017
nct id: NCT03245216
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is designed to assess the effects of aerobic exercise on motor learning in
      Parkinson patients. Specifically, the investigators examine whether a single bout of moderate
      intensity aerobic exercise, performed immediately before task practice, facilitates the
      acquisition and retention of a motor skill. In a cross-over design, participants will be
      randomly allocated to either the intervention group (aerobic exercise before motor learning)
      or control group (rest before motor learning).
Parkinson's disease is a progressive neurodegenerative disorder that is characterized by
      motor control impairments, such as gait disturbances and postural instability. Beneficial
      effects of exercise are attributed to mechanisms of neuroplasticity, and task-specific motor
      training is consequently considered to be a motor learning process. While motor learning is
      preserved in persons with Parkinson's disease, slower acquisition rates and reduced retention
      have been reported compared to healthy individuals.

      Thus, it is crucial to identify strategies to enhance motor learning in people with
      Parkinson's disease. Recent studies have accumulated evidence to show that aerobic exercise
      can facilitate motor skill learning. However, these observations are limited to healthy
      individuals and have not been addressed in individuals with neurologic conditions.

      The present study is designed to assess the effects of a single bout of moderate intensity
      aerobic exercise on a motor skill learning task in patients with Parkinson's disease.

      In a cross-over design, participants will be randomly allocated to one of two groups. Both
      groups will practice balancing on a specific stability platform (motor learning task). The
      experimental group will additionally perform a bout of aerobic exercise (cycle ergometer)
      immediately before the motor learning task, while the control group will rest before
      practice. Subsequently, the acquisition and one-day retention of the motor learning task will
      be examined.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Motor Learning (Precision)
time frame: Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).
description: Change from baseline in time in balance (±5° from horizontal) during balancing task.
measure: Motor Learning (Variability)
time frame: Baseline (first trial of practice day 1), 1 day (last trial of practice day 1), and 7 days (first trial of 7-day retention session).
description: Change from baseline in mean standard deviation (root mean square error) of platform deflection (in degree).
arm group label: aerobic exercise + motor skill practice
arm group type: Experimental
description: acute bout of aerobic exercise before motor learning
arm group label: rest + motor skill practice
arm group type: Active Comparator
description: seated rest before motor learning
intervention type: Behavioral
intervention name: aerobic exercise
description: Single-bout of moderate intensity aerobic exercise on a cycle ergometer before motor learning
arm group label: aerobic exercise + motor skill practice
intervention type: Behavioral
intervention name: rest
description: Seated rest before motor learning
arm group label: rest + motor skill practice
intervention type: Behavioral
intervention name: motor learning
description: Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in an horizontal position.
arm group label: aerobic exercise + motor skill practice
arm group label: rest + motor skill practice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Steib, Dr.
role: Principal Investigator
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport
facility: 
country: Germany
url: https://www.sport.fau.de/lehrstuehle-und-fachgebiete/bewegung-und-gesundheit/forschungsprojekte/optimierung-motorischer-lernprozesse-in-der-rehabilitation-von-parkinsonpatienten/
description: project webpage
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg
investigator full name: Simon Steib, PhD
investigator title: Dr.
mesh term: Parkinson Disease
sharing ipd: Undecided