Clinical trial NCT05994508: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Mini-BEStest
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
measure: 10-Meter Walk Test
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
measure: Grip strength dynamometry
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
Secondary outcomes:
measure: The shirt-buttoning task
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
measure: 9-Hole Peg Test
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
measure: Parkinson's Disease Questionnaire-8
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
measure: PD-Pain Classification System
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
measure: Montreal Cognitive Assessment
timeFrame: Within 7 day before and after the intervention as well as one-month after intervention completion
Other outcomes:
Locations:
Study officials:
affiliation: Midwestern University
name: Suzanne O'Neal, DPT, DHSc
role: PRINCIPAL_INVESTIGATOR
References: