Golf Instruction Versus Tai Chi for People With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03563807|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Movement Disorders Neuro-Degenerative Disease||Other: Golf Instruction Other: Tai Chi Class||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
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.
- 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.
- 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
- 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.
- 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
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
|Contact: Remy Johnsonemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Remy Johnson, BA 617-726-4936 firstname.lastname@example.org|
|Contact: Kate Gilpin, BA 617-726-4936 email@example.com|
|Principal Investigator: Anne-Marie Wills, MD MPH|