<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/NCT03833349</url>
  </required_header>
  <id_info>
    <org_study_id>06538</org_study_id>
    <nct_id>NCT03833349</nct_id>
  </id_info>
  <brief_title>The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease</brief_title>
  <acronym>PDExercise</acronym>
  <official_title>The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Premier Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parkinson's Disease Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Premier Health</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 purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and&#xD;
      depression in Parkinson's disease. It is well established that exercise improves the motor&#xD;
      symptoms of Parkinson's disease. However, it is not clear which types of exercise are most&#xD;
      beneficial for specific non-motor symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-site trial (12 patients in each site). The investigators are recruiting 24&#xD;
      patients who will be randomized into either a spinning class, yoga class, dance class, or no&#xD;
      exercise intervention. Classes will be conducted twice a week for 6 weeks total at times&#xD;
      convenient for the patients. Patients will also be asked to complete questionnaires after&#xD;
      exercise classes to see if the exercise intervention improves measures of fatigue, anxiety,&#xD;
      and depression - and what exercise intervention may be superior. All participants will be&#xD;
      asked to complete questionnaires each week and will be asked to wear a &quot;Microsoft exercise&#xD;
      band&quot; during the course of the study. Use of the exercise band is optional.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">October 2, 2019</completion_date>
  <primary_completion_date type="Actual">October 2, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline, if any, in subjects' Fatigue Severity Scale</measure>
    <time_frame>screening through study completion, up to 18 weeks</time_frame>
    <description>Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 1(strongly disagree) to 7(strongly agree).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline, if any, in subjects' Zung self-report Anxiety Scale</measure>
    <time_frame>screening through study completion, up to 18 weeks</time_frame>
    <description>Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 1(a little of the time) to 4(most of the time).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline, if any, in subjects' Beck Depression Inventory II scale</measure>
    <time_frame>screening through study completion, up to 18 weeks</time_frame>
    <description>Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 0(Normal) to 3(Severe).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Spinning Class</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomly selected for the spinning group will participate in spinning classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yoga Class</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomly selected for the yoga group will participate in yoga classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dance Class</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomly selected for the dance group will participate in dance classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Spinning Class</intervention_name>
    <description>Spinning Class twice a week for six weeks.</description>
    <arm_group_label>Spinning Class</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga Class</intervention_name>
    <description>Yoga Class twice a week for six weeks.</description>
    <arm_group_label>Yoga Class</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dance Class</intervention_name>
    <description>Dance Class twice a week for six weeks.</description>
    <arm_group_label>Dance Class</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects diagnosed with Idiopathic Parkinson's Disease&#xD;
&#xD;
          2. Age between 18 - 75 years&#xD;
&#xD;
          3. Hoehn and Yahr stage less than or equal to 3&#xD;
&#xD;
          4. Mini-Mental State Exam (MMSE) score of over 23 at screening&#xD;
&#xD;
          5. If subjects are taking any medications for depression, fatigue, or anxiety, regimen&#xD;
             must be stable for 8 weeks prior to baseline visit&#xD;
&#xD;
          6. Subjects willing and able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with a diagnosis of an atypical Parkinsonism&#xD;
&#xD;
          2. Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider&#xD;
&#xD;
          3. Score of 60 or more on UPDRS III at screening&#xD;
&#xD;
          4. Scores in the 'normal' range on all three study assessments: Beck Depression Index II,&#xD;
             Fatigue Severity Scale, and Zung self-rating Anxiety Scale&#xD;
&#xD;
          5. Participation in any of the 3 physical activities more than 3 times in the past for 8&#xD;
             weeks prior to baseline&#xD;
&#xD;
          6. Any other reason that, in the investigator's opinion, would exclude the subject from&#xD;
             participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Feldman, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Premier Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Health</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>fatigue</keyword>
  <keyword>anxiety</keyword>
  <keyword>depression</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Depression</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/NCT03833349
org study id: 06538
nct id: NCT03833349
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and
      depression in Parkinson's disease. It is well established that exercise improves the motor
      symptoms of Parkinson's disease. However, it is not clear which types of exercise are most
      beneficial for specific non-motor symptoms.
This is a multi-site trial (12 patients in each site). The investigators are recruiting 24
      patients who will be randomized into either a spinning class, yoga class, dance class, or no
      exercise intervention. Classes will be conducted twice a week for 6 weeks total at times
      convenient for the patients. Patients will also be asked to complete questionnaires after
      exercise classes to see if the exercise intervention improves measures of fatigue, anxiety,
      and depression - and what exercise intervention may be superior. All participants will be
      asked to complete questionnaires each week and will be asked to wear a "Microsoft exercise
      band" during the course of the study. Use of the exercise band is optional.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline, if any, in subjects' Fatigue Severity Scale
time frame: screening through study completion, up to 18 weeks
description: Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 1(strongly disagree) to 7(strongly agree).
measure: Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
time frame: screening through study completion, up to 18 weeks
description: Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 1(a little of the time) to 4(most of the time).
measure: Change from baseline, if any, in subjects' Beck Depression Inventory II scale
time frame: screening through study completion, up to 18 weeks
description: Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 0(Normal) to 3(Severe).
arm group label: Spinning Class
arm group type: Experimental
description: Subjects randomly selected for the spinning group will participate in spinning classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.
arm group label: Yoga Class
arm group type: Experimental
description: Subjects randomly selected for the yoga group will participate in yoga classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.
arm group label: Dance Class
arm group type: Experimental
description: Subjects randomly selected for the dance group will participate in dance classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.
intervention type: Behavioral
intervention name: Spinning Class
description: Spinning Class twice a week for six weeks.
arm group label: Spinning Class
intervention type: Behavioral
intervention name: Yoga Class
description: Yoga Class twice a week for six weeks.
arm group label: Yoga Class
intervention type: Behavioral
intervention name: Dance Class
description: Dance Class twice a week for six weeks.
arm group label: Dance Class
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mary Feldman, DO
role: Principal Investigator
affiliation: Premier Health
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Fatigue
mesh term: Depression
sharing ipd: Undecided