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
About this trial
This is an interventional treatment trial for Parkinson Disease
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).
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
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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