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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563807
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Movement Disorders Neuro-Degenerative Disease Other: Golf Instruction Other: Tai Chi Class Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: A blinded rater will perform the Mini-BESTest of balance before and after the intervention
Primary Purpose: Supportive Care
Official Title: Feasibility and Tolerability of Group Golf Instruction Versus Tai Chi for Patients With Moderate to Advanced Parkinson's Disease
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Golf
Group golf lessons will be led by professional golf instructors.
Other: Golf Instruction
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.

Active Comparator: Tai Chi
Group Tai Chi classes led by a certified Tai Chi instructor.
Other: Tai Chi Class
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 Measures :
  1. Tolerability of group golf instruction compared to Tai Chi [ Time Frame: Both interventions will continue for 10 weeks and subject participation rates will be recorded during this time. ]
    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 :
  1. Safety of group golf instruction compared to Tai Chi [ Time Frame: Both interventions will continue for 10 weeks and any adverse events will be recorded during this time. ]
    The frequency of treatment-related adverse events including falls will be summarized by treatment group and system organ class by CTCAE v 4.0

  2. Key Secondary objectives are to measure the efficacy of golf instruction compared to Tai Chi on measures of balance. [ 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. ]
    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.

  3. Activities Specific Balance Confidence Scale [ Time Frame: Both interventions will continue for 10 weeks. Participants will complete the questionnaire before and after the intervention period. ]
    This is a self-reported measure of confidence in performing various ambulatory activities without falling. The scale is out of 100



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563807


Contacts
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Contact: Remy Johnson 617-726-4936 rkjohnson@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Remy Johnson, BA    617-726-4936    rkjohnson@mgh.harvard.edu   
Contact: Kate Gilpin, BA    617-726-4936    kkgilpin@mgh.harvard.edu   
Principal Investigator: Anne-Marie Wills, MD MPH         
Sponsors and Collaborators
Massachusetts General Hospital

Publications:
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Responsible Party: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03563807    
Other Study ID Numbers: 2018P000394
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases