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Golf Instruction Versus Tai Chi for People With Parkinson's Disease

Primary Purpose

Parkinson Disease, Movement Disorders, Neuro-Degenerative Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Golf Instruction
Tai Chi Class
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult participants with a diagnosis of Parkinson's disease by a Movement Disorders specialist, H&Y stage II-III in the "On" state treated with Parkinson's disease medications
  • Participants must be capable of providing informed consent and complying with trial procedures including transportation to and from classes.
  • Participants must be willing and able to participate in group exercise classes.
  • Participants who are engaged in physical therapy or other exercise programs must be at a stable regimen for 60 days prior to the start of the study and must be willing to maintain their current regimen for the duration of the study.

Exclusion Criteria:

  • Clinical evidence of unstable medical or psychiatric illness which would prevent them from engaging in exercise
  • Participants who are already active golfers or currently active in Tai Chi would be excluded.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Golf

Tai Chi

Arm Description

Group golf lessons will be led by professional golf instructors.

Group Tai Chi classes led by a certified Tai Chi instructor.

Outcomes

Primary Outcome Measures

Tolerability of group golf instruction compared to Tai Chi
The number of participants who complete 10 weeks in the study will be measured using weekly attendance sheets. We will consider the intervention to be tolerable if the proportion of participants who withdraw consent prior to the end of the study is less than 40% with 80% confidence.

Secondary Outcome Measures

Safety of group golf instruction compared to Tai Chi
The frequency of treatment-related adverse events including falls will be summarized by treatment group and system organ class by CTCAE v 4.0
Key Secondary objectives are to measure the efficacy of golf instruction compared to Tai Chi on measures of balance.
The Mini-BESTest will be used to measure balance before and after the intervention. The Mini-BESTest is scored from 0-28 where lower scores are better.
Activities Specific Balance Confidence Scale
This is a self-reported measure of confidence in performing various ambulatory activities without falling. The scale is out of 100

Full Information

First Posted
May 8, 2018
Last Updated
September 2, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03563807
Brief Title
Golf Instruction Versus Tai Chi for People With Parkinson's Disease
Official Title
Feasibility and Tolerability of Group Golf Instruction Versus Tai Chi for Patients With Moderate to Advanced Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

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
The purpose of this study is to determine the feasibility and tolerability of golf instruction for participants with moderate to advanced Parkinson's disease (PD). Other forms of exercise have been shown to be beneficial for PD. Golf is a low impact sport that utilizes balance and strength. Currently, there are no data looking at the effects of golf on PD. This pilot study aims to test the effects of golf in the PD patient population, particularly its effect on balance. In this study, we will be comparing group golf instruction to group Tai Chi lessons (the gold standard balance exercise for patients with PD).
Detailed Description
Approximately, 40-50 participants with Parkinson's Disease (H&Y stage 2 to 3) will be enrolled in this study. Participants who provide informed consent will be randomized 1:1 to either group golf instruction or group Tai Chi classes. Participants will be evaluated before and after the intervention with a battery of cognitive, motor and balance assessments including the UPDRS, the Mini-BESTest of balance, and timed up and go tests. They will participate in classes twice weekly for 10 weeks which will be provided free of charge. At the end of the intervention period they will repeat the assessments. The primary outcomes of the study are feasibility and tolerability. The key secondary objectives are to measure the efficacy of golf instruction on measures of balance, risk of falls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Movement Disorders, Neuro-Degenerative Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
A blinded rater will perform the Mini-BESTest of balance before and after the intervention
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Golf
Arm Type
Experimental
Arm Description
Group golf lessons will be led by professional golf instructors.
Arm Title
Tai Chi
Arm Type
Active Comparator
Arm Description
Group Tai Chi classes led by a certified Tai Chi instructor.
Intervention Type
Other
Intervention Name(s)
Golf Instruction
Intervention Description
Subjects will participate in two weekly hour-long golf classes. Classes will be led by professional golf instructors that will work with individuals to teach participants how to play golf. This will include stretching, individual coaching, and working with participants to maximize their golf swing.
Intervention Type
Other
Intervention Name(s)
Tai Chi Class
Intervention Description
Tai Chi is an ancient martial art that uses meditative movement to improve strength, flexibility, and balance. Subjects will participate in two weekly hour-long Tai Chi classes.The class will be led by a certified Tai Chi instructor and consist of approximately 12 people.
Primary Outcome Measure Information:
Title
Tolerability of group golf instruction compared to Tai Chi
Description
The number of participants who complete 10 weeks in the study will be measured using weekly attendance sheets. We will consider the intervention to be tolerable if the proportion of participants who withdraw consent prior to the end of the study is less than 40% with 80% confidence.
Time Frame
Both interventions will continue for 10 weeks and subject participation rates will be recorded during this time.
Secondary Outcome Measure Information:
Title
Safety of group golf instruction compared to Tai Chi
Description
The frequency of treatment-related adverse events including falls will be summarized by treatment group and system organ class by CTCAE v 4.0
Time Frame
Both interventions will continue for 10 weeks and any adverse events will be recorded during this time.
Title
Key Secondary objectives are to measure the efficacy of golf instruction compared to Tai Chi on measures of balance.
Description
The Mini-BESTest will be used to measure balance before and after the intervention. The Mini-BESTest is scored from 0-28 where lower scores are better.
Time Frame
Both interventions will continue for 10 weeks. The Mini-BESTest will be performed by a blinded rater before and after the intervention period.
Title
Activities Specific Balance Confidence Scale
Description
This is a self-reported measure of confidence in performing various ambulatory activities without falling. The scale is out of 100
Time Frame
Both interventions will continue for 10 weeks. Participants will complete the questionnaire before and after the intervention period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult participants with a diagnosis of Parkinson's disease by a Movement Disorders specialist, H&Y stage II-III in the "On" state treated with Parkinson's disease medications Participants must be capable of providing informed consent and complying with trial procedures including transportation to and from classes. Participants must be willing and able to participate in group exercise classes. Participants who are engaged in physical therapy or other exercise programs must be at a stable regimen for 60 days prior to the start of the study and must be willing to maintain their current regimen for the duration of the study. Exclusion Criteria: Clinical evidence of unstable medical or psychiatric illness which would prevent them from engaging in exercise Participants who are already active golfers or currently active in Tai Chi would be excluded.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29027544
Citation
Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.
Results Reference
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PubMed Identifier
22316445
Citation
Li F, Harmer P, Fitzgerald K, Eckstrom E, Stock R, Galver J, Maddalozzo G, Batya SS. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012 Feb 9;366(6):511-9. doi: 10.1056/NEJMoa1107911.
Results Reference
background
PubMed Identifier
21416145
Citation
Gao KL, Hui-Chan CW, Tsang WW. Golfers have better balance control and confidence than healthy controls. Eur J Appl Physiol. 2011 Nov;111(11):2805-12. doi: 10.1007/s00421-011-1910-7. Epub 2011 Mar 17.
Results Reference
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Golf Instruction Versus Tai Chi for People With Parkinson's Disease

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