Clinical trial NCT03563807: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Movement Disorders
Neuro-Degenerative Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Tolerability of group golf instruction compared to Tai Chi
timeFrame: Both interventions will continue for 10 weeks and subject participation rates will be recorded during this time.
Secondary outcomes:
measure: Safety of group golf instruction compared to Tai Chi
timeFrame: Both interventions will continue for 10 weeks and any adverse events will be recorded during this time.
measure: Key Secondary objectives are to measure the efficacy of golf instruction compared to Tai Chi on measures of balance.
timeFrame: Both interventions will continue for 10 weeks. The Mini-BESTest will be performed by a blinded rater before and after the intervention period.
measure: Activities Specific Balance Confidence Scale
timeFrame: Both interventions will continue for 10 weeks. Participants will complete the questionnaire before and after the intervention period.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
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.
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.
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.