- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05994508
Feasibility and Effects of a Pickleball Program for People With Parkinson Disease
August 8, 2023 updated by: Midwestern University
A Community Pickleball Program for People With Parkinson Disease: A Feasibility and Preliminary Results Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Suzanne O'Neal, DPT, DHSc
- Phone Number: 6235723938
- Email: soneal@midwestern.edu
Study Contact Backup
- Name: Tara McIsaac, PhD
- Phone Number: 6028124582
- Email: taramcisaac@creighton.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-BEStest
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
Comprehensive balance assessment
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
10-Meter Walk Test
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
Measure of gait speed
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
Grip strength dynamometry
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
Assessment of grip strength
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The shirt-buttoning task
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
An upper limb functional performance test
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
9-Hole Peg Test
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
Assessment of finger dexterity
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
Parkinson's Disease Questionnaire-8
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
Measure of perceived quality of life
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
PD-Pain Classification System
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
Tool for differentiating PD-pain from PD-unrelated pain
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
Montreal Cognitive Assessment
Time Frame: Within 7 day before and after the intervention as well as one-month after intervention completion
|
Assessment of cognitive abilities
|
Within 7 day before and after the intervention as well as one-month after intervention completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzanne O'Neal, DPT, DHSc, Midwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
August 8, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Actual)
August 16, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBAZ/5214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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