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Feasibility and Effects of a Pickleball Program for People With Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pickleball program
Sponsored by
Midwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of idiopathic Parkinson disease, able to walk without an assistive device, and able to tolerate 45 minutes of activity with occasional seated rest. Exclusion Criteria: Diagnosis of any other neurologic disorder, any current illness, injury, or cognitive function that would prevent ability to perform the study tasks, and not regularly participating in pickleball (less than 3 times a month).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Mini-BEStest
    Comprehensive balance assessment
    10-Meter Walk Test
    Measure of gait speed
    Grip strength dynamometry
    Assessment of grip strength

    Secondary Outcome Measures

    The shirt-buttoning task
    An upper limb functional performance test
    9-Hole Peg Test
    Assessment of finger dexterity
    Parkinson's Disease Questionnaire-8
    Measure of perceived quality of life
    PD-Pain Classification System
    Tool for differentiating PD-pain from PD-unrelated pain
    Montreal Cognitive Assessment
    Assessment of cognitive abilities

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    August 8, 2023
    Sponsor
    Midwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05994508
    Brief Title
    Feasibility and Effects of a Pickleball Program for People With Parkinson Disease
    Official Title
    A Community Pickleball Program for People With Parkinson Disease: A Feasibility and Preliminary Results Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Midwestern University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants
    Arm Type
    Experimental
    Arm 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(s)
    Pickleball program
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Mini-BEStest
    Description
    Comprehensive balance assessment
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion
    Title
    10-Meter Walk Test
    Description
    Measure of gait speed
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion
    Title
    Grip strength dynamometry
    Description
    Assessment of grip strength
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion
    Secondary Outcome Measure Information:
    Title
    The shirt-buttoning task
    Description
    An upper limb functional performance test
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion
    Title
    9-Hole Peg Test
    Description
    Assessment of finger dexterity
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion
    Title
    Parkinson's Disease Questionnaire-8
    Description
    Measure of perceived quality of life
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion
    Title
    PD-Pain Classification System
    Description
    Tool for differentiating PD-pain from PD-unrelated pain
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion
    Title
    Montreal Cognitive Assessment
    Description
    Assessment of cognitive abilities
    Time Frame
    Within 7 day before and after the intervention as well as one-month after intervention completion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of idiopathic Parkinson disease, able to walk without an assistive device, and able to tolerate 45 minutes of activity with occasional seated rest. Exclusion Criteria: Diagnosis of any other neurologic disorder, any current illness, injury, or cognitive function that would prevent ability to perform the study tasks, and not regularly participating in pickleball (less than 3 times a month).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzanne O'Neal, DPT, DHSc
    Phone
    6235723938
    Email
    soneal@midwestern.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tara McIsaac, PhD
    Phone
    6028124582
    Email
    taramcisaac@creighton.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suzanne O'Neal, DPT, DHSc
    Organizational Affiliation
    Midwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Feasibility and Effects of a Pickleball Program for People With Parkinson Disease

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