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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05994508
Other study ID # IRBAZ/5214
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date May 2024

Study information

Verified date August 2023
Source Midwestern University
Contact Suzanne O'Neal, DPT, DHSc
Phone 6235723938
Email soneal@midwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16
Est. completion date May 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Pickleball program
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Midwestern University

Outcome

Type Measure Description Time frame Safety issue
Primary Mini-BEStest Comprehensive balance assessment Within 7 day before and after the intervention as well as one-month after intervention completion
Primary 10-Meter Walk Test Measure of gait speed Within 7 day before and after the intervention as well as one-month after intervention completion
Primary Grip strength dynamometry Assessment of grip strength Within 7 day before and after the intervention as well as one-month after intervention completion
Secondary The shirt-buttoning task An upper limb functional performance test Within 7 day before and after the intervention as well as one-month after intervention completion
Secondary 9-Hole Peg Test Assessment of finger dexterity Within 7 day before and after the intervention as well as one-month after intervention completion
Secondary Parkinson's Disease Questionnaire-8 Measure of perceived quality of life Within 7 day before and after the intervention as well as one-month after intervention completion
Secondary PD-Pain Classification System 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
Secondary Montreal Cognitive Assessment Assessment of cognitive abilities Within 7 day before and after the intervention as well as one-month after intervention completion
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