Feasibility and Tolerability of Group Golf Instruction Versus Tai Chi for Patients With Moderate to Advanced Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Tolerability of group golf instruction compared to Tai Chi
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded rater will perform the Mini-BESTest of balance before and after the intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Tolerability of group golf instruction compared to Tai Chi
时间窗: 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.
次要结局
- Activities Specific Balance Confidence Scale(Both interventions will continue for 10 weeks. Participants will complete the questionnaire before and after the intervention period.)
- Safety of group golf instruction compared to Tai Chi(Both interventions will continue for 10 weeks and any adverse events will be recorded during this time.)
- Key Secondary objectives are to measure the efficacy of golf instruction compared to Tai Chi on measures of balance.(Both interventions will continue for 10 weeks. The Mini-BESTest will be performed by a blinded rater before and after the intervention period.)
研究者
Anne-Marie Alexandra Wills, MD
Assistant Professor of Neurology
Massachusetts General Hospital