The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change from baseline, if any, in subjects' Fatigue Severity Scale
研究概览
简要总结
The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.
详细描述
The investigators are recruiting 32 patients who will be randomized into either a spinning class, yoga class, dance class, or no exercise intervention. Classes will be conducted twice a week for 6 weeks total at times convenient for the patients. Patients will also be asked to complete questionnaires after exercise classes to see if the exercise intervention improves measures of fatigue, anxiety, and depression - and what exercise intervention may be superior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with Idiopathic Parkinson's Disease
- •Age between 18 - 75 years
- •Hoehn and Yahr stage less than or equal to 3
- •Mini-Mental State Exam (MMSE) score of over 23 at screening
- •If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit
- •Subjects willing and able to give informed consent
排除标准
- •Subjects with a diagnosis of an atypical Parkinsonism
- •Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider
- •Score of 60 or more on UPDRS III at screening
- •Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale
- •Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline
- •Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study
结局指标
主要结局
Change from baseline, if any, in subjects' Fatigue Severity Scale
时间窗: screening through study completion, up to 18 weeks
Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
时间窗: screening through study completion, up to 18 weeks
Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Change from baseline, if any, in subjects' Beck Depression Inventory II scale
时间窗: screening through study completion, up to 18 weeks
Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
次要结局
未报告次要终点