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

Sponsor
Midwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05994508
Collaborator
(none)
16
1
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pickleball program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Community Pickleball Program for People With Parkinson Disease: A Feasibility and Preliminary Results Study
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Mini-BEStest [Within 7 day before and after the intervention as well as one-month after intervention completion]

    Comprehensive balance assessment

  2. 10-Meter Walk Test [Within 7 day before and after the intervention as well as one-month after intervention completion]

    Measure of gait speed

  3. Grip strength dynamometry [Within 7 day before and after the intervention as well as one-month after intervention completion]

    Assessment of grip strength

Secondary Outcome Measures

  1. The shirt-buttoning task [Within 7 day before and after the intervention as well as one-month after intervention completion]

    An upper limb functional performance test

  2. 9-Hole Peg Test [Within 7 day before and after the intervention as well as one-month after intervention completion]

    Assessment of finger dexterity

  3. Parkinson's Disease Questionnaire-8 [Within 7 day before and after the intervention as well as one-month after intervention completion]

    Measure of perceived quality of life

  4. PD-Pain Classification System [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

  5. Montreal Cognitive Assessment [Within 7 day before and after the intervention as well as one-month after intervention completion]

    Assessment of cognitive abilities

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Midwestern University

Investigators

  • Principal Investigator: Suzanne O'Neal, DPT, DHSc, Midwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Midwestern University
ClinicalTrials.gov Identifier:
NCT05994508
Other Study ID Numbers:
  • IRBAZ/5214
First Posted:
Aug 16, 2023
Last Update Posted:
Aug 16, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2023