xml: <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/NCT05994508</url>
    </required_header>
    <id_info>
      <org_study_id>IRBAZ/5214</org_study_id>
      <nct_id>NCT05994508</nct_id>
    </id_info>
    <brief_title>Feasibility and Effects of a Pickleball Program for People With Parkinson Disease</brief_title>
    <official_title>A Community Pickleball Program for People With Parkinson Disease: A Feasibility and Preliminary Results Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Midwestern University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Midwestern University</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>
        Pickleball is a fast-growing sport that has been shown to improve social integration, life&#xD;
        satisfaction, function, and cognitive function in older adults. Parkinson disease is a&#xD;
        neurodegenerative disorder characterized by bradykinesia, rigidity, tremors, and postural&#xD;
        instability. Exercise has been shown to improve physical and cognitive function in people&#xD;
        with Parkinson disease (PD). The purpose of this study is to assess if a community pickleball&#xD;
        program can be a feasible and effective for people living with PD.The primary aim of this&#xD;
        study is to assess the feasibility of a group pickleball program for people with PD.&#xD;
        Secondary aims is to assess the effects of a 6-week pickleball exercise program on balance,&#xD;
        gait, cognition, upper extremity function, pain, and quality of life in people with PD. This&#xD;
        will be a pre-test, post-test single-group, prospective, mixed-methods study with 1- month&#xD;
        follow-up. Sixteen participants will be enrolled in a 6-week pickleball program, at a&#xD;
        frequency of twice a week for one hour each session. Feasibility will be assessed by&#xD;
        retention rates, adherence rates, resources, and number of adverse events. Quantitative data&#xD;
        to be collected will include the Mini-BESTest, gait and body posture variables, Parkinson's&#xD;
        Disease Questionnaire-8, the Shirt-Buttoning Task, 9 Hole Peg Test, grip strength, PD-Pain&#xD;
        Classification System, and the National Institutes of Health Toolbox Cognition Battery.&#xD;
        Additionally, participants will be scheduled for small semi-structured focus group interviews&#xD;
        to gain qualitative data about their experiences of the program. It is hypothesized that a&#xD;
        pickleball program for people living with PD will be a feasible activity and will result in&#xD;
        improvements in balance, gait, cognition, upper extremity function, and quality of life.&#xD;
        Additionally, it is hypothesized that participants will have a favorable opinion on the&#xD;
        activity.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mini-BEStest</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>Comprehensive balance assessment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>10-Meter Walk Test</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>Measure of gait speed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Grip strength dynamometry</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>Assessment of grip strength</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The shirt-buttoning task</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>An upper limb functional performance test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>9-Hole Peg Test</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>Assessment of finger dexterity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parkinson's Disease Questionnaire-8</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>Measure of perceived quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PD-Pain Classification System</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>Tool for differentiating PD-pain from PD-unrelated pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment</measure>
      <time_frame>Within 7 day before and after the intervention as well as one-month after intervention completion</time_frame>
      <description>Assessment of cognitive abilities</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single group of participants with Parkinson disease will participate in a 6-week pickleball program with pre-test, post-test, and one month follow-up testing.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pickleball program</intervention_name>
      <description>The intervention will be a 6-week pickleball program, at a frequency of two times a week. Each session will be one hour which will consist of dynamic warm-up drills, pickleball-related skill practice and game play, and a cool-down period.</description>
      <arm_group_label>Participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Diagnosis of idiopathic Parkinson disease, able to walk without an assistive device, and&#xD;
          able to tolerate 45 minutes of activity with occasional seated rest.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Diagnosis of any other neurologic disorder, any current illness, injury, or cognitive&#xD;
          function that would prevent ability to perform the study tasks, and not regularly&#xD;
          participating in pickleball (less than 3 times a month).&#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>Suzanne O'Neal, DPT, DHSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Midwestern University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suzanne O'Neal, DPT, DHSc</last_name>
      <phone>6235723938</phone>
      <email>soneal@midwestern.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tara McIsaac, PhD</last_name>
      <phone>6028124582</phone>
      <email>taramcisaac@creighton.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994508
  org study id: IRBAZ/5214
  nct id: NCT05994508
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pickleball is a fast-growing sport that has been shown to improve social integration, life
        satisfaction, function, and cognitive function in older adults. Parkinson disease is a
        neurodegenerative disorder characterized by bradykinesia, rigidity, tremors, and postural
        instability. Exercise has been shown to improve physical and cognitive function in people
        with Parkinson disease (PD). The purpose of this study is to assess if a community pickleball
        program can be a feasible and effective for people living with PD.The primary aim of this
        study is to assess the feasibility of a group pickleball program for people with PD.
        Secondary aims is to assess the effects of a 6-week pickleball exercise program on balance,
        gait, cognition, upper extremity function, pain, and quality of life in people with PD. This
        will be a pre-test, post-test single-group, prospective, mixed-methods study with 1- month
        follow-up. Sixteen participants will be enrolled in a 6-week pickleball program, at a
        frequency of twice a week for one hour each session. Feasibility will be assessed by
        retention rates, adherence rates, resources, and number of adverse events. Quantitative data
        to be collected will include the Mini-BESTest, gait and body posture variables, Parkinson's
        Disease Questionnaire-8, the Shirt-Buttoning Task, 9 Hole Peg Test, grip strength, PD-Pain
        Classification System, and the National Institutes of Health Toolbox Cognition Battery.
        Additionally, participants will be scheduled for small semi-structured focus group interviews
        to gain qualitative data about their experiences of the program. It is hypothesized that a
        pickleball program for people living with PD will be a feasible activity and will result in
        improvements in balance, gait, cognition, upper extremity function, and quality of life.
        Additionally, it is hypothesized that participants will have a favorable opinion on the
        activity.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Mini-BEStest
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: Comprehensive balance assessment
  measure: 10-Meter Walk Test
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: Measure of gait speed
  measure: Grip strength dynamometry
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: Assessment of grip strength
  measure: The shirt-buttoning task
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: An upper limb functional performance test
  measure: 9-Hole Peg Test
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: Assessment of finger dexterity
  measure: Parkinson's Disease Questionnaire-8
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: Measure of perceived quality of life
  measure: PD-Pain Classification System
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: Tool for differentiating PD-pain from PD-unrelated pain
  measure: Montreal Cognitive Assessment
  time frame: Within 7 day before and after the intervention as well as one-month after intervention completion
  description: Assessment of cognitive abilities
  arm group label: Participants
  arm group type: Experimental
  description: A single group of participants with Parkinson disease will participate in a 6-week pickleball program with pre-test, post-test, and one month follow-up testing.
  intervention type: Other
  intervention name: Pickleball program
  description: The intervention will be a 6-week pickleball program, at a frequency of two times a week. Each session will be one hour which will consist of dynamic warm-up drills, pickleball-related skill practice and game play, and a cool-down period.
  arm group label: Participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Suzanne O'Neal, DPT, DHSc
  role: Principal Investigator
  affiliation: Midwestern University
  last name: Suzanne O'Neal, DPT, DHSc
  phone: 6235723938
  email: soneal@midwestern.edu
  last name: Tara McIsaac, PhD
  phone: 6028124582
  email: taramcisaac@creighton.edu
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No