NCT03463330Unknown不适用
Benefits of Mild Body Exercises in Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Parkinson's Disease Sleep Scale (PDSS-2)
研究概览
简要总结
The purpose of this study is to learn the effects of two mild body exercises on quality of life, non-motor symptoms, anxiety, depression, fatigue, sleep quality, cognition, and executive function on people with Parkinson's Disease (PD).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD
- •Currently taking levodopa with some improvement in motor symptoms, and on a stable dose for a minimum of 4 weeks prior to starting the study
- •Hoehn & Yahr stage I to III (mild to moderate PD)
排除标准
- •Mini Mental State Examination (MMSE) score < 24
- •Central neurological diseases other than PD or prior major head trauma with loss of consciousness, including other forms of parkinsonism, uncontrolled or significant cardiovascular diseases, orthopedic or medical problems that would interfere with gait
- •Being primarily wheelchair bound
- •Deep brain stimulation
- •Expected change in PD medications over the course of the study
- •Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
结局指标
主要结局
Parkinson's Disease Sleep Scale (PDSS-2)
时间窗: Change from Baseline to Week 12
This instrument has a total range of scores between 0 and 60. The lower the score the better.
次要结局
- Geriatric Depression Scale (GDS-15)(Change from Baseline to Week 12)
- Parkinson Fatigue Scale (PFS-16)(Change from Baseline to Week 12)
- Parkinson's Disease-Cognitive Rating Scale (PD-CRS)(Change from Baseline to Week 12)
- Frontal Assessment Battery (FAB-18)(Change from Baseline to Week 12)
- IL-1beta(Change from Baseline to Week 12)
- TNF-alpha(Change from Baseline to Week 12)
- Trail Making Test parts A(Change from Baseline to Week 12)
- Non Motor Symptom Questionnaire (NMSQuest)(Change from Baseline to Week 12)
- Geriatric Anxiety Scale (GAS-10)(Change from Baseline to Week 12)
- Parkinson's Disease Questionnaire (PDQ-39)(Change from Baseline to Week 12)
- Unified Parkinson Disease Rating Scale (UPDRS)(Change from Baseline to Week 12)
- Trail Making Test parts B(Change from Baseline to Week 12)
- IL-6(Change from Baseline to Week 12)
研究者
研究点 (2)
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