Research on the Effect and Mechanism of Aerobic Exercise on PD
2020年12月30日 更新者：Zhang Ying、The First Hospital of Jilin University
Research on the Effect and Mechanism of Aerobic Exercise on Parkinson's
This trial is expected to recruit patients with primary Parkinson's disease and give them four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism
研究概览
详细说明
This trial is expected to recruit patients with primary Parkinson's disease who are distributed into tremor group and stiff group and give them the same kind of four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Changchun、中国、130021
- FirstJilinU
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants were diagnosed primary PD according to the 2015 MDS diagnostic criteria
- Participants are between 55 and 65 years old
Exclusion Criteria:
- Severe heart
- liver dysfunction
- kidney dysfunction
- severe cognitive dysfunction
- severe anxiety and depression
- history of mental illness
- history of cerebral infarction or ischemic attack in the past three months
- acute myocardial infarction or acute coronary in the past three months
- Parkinson's Pulse syndrome
- medication history (drugs that improve blood circulation in the brain and increase the excitability of the nervous system)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Tremor group
Participants in the tremor group have tremor as the main clinical manifestation
|
Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks
|
|
有源比较器：Stiff group
Participants in the tremor group have stiff as the main clinical manifestation
|
Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS)
大体时间：changes of MDS-UPDRS score from baseline at four weeks
|
to assess the motor and nonmotor function of PD,0-200 scores,the higher scores mean lower function
|
changes of MDS-UPDRS score from baseline at four weeks
|
|
Montreal Cognitive Assessing(MoCA) score
大体时间：changes of MoCA score from baseline at four weeks
|
to assess the cognitive function of PD,0-30 scores,the higher scores mean better function
|
changes of MoCA score from baseline at four weeks
|
|
The Epworth Sleeping Scale(ESS)
大体时间：changes of ESS score from baseline at four weeks
|
to assess the degree of drowsiness, 0-24 scores, the higher scores mean severe drowsiness
|
changes of ESS score from baseline at four weeks
|
|
Non-Motor Symptom Scale (NMSS)
大体时间：changes of NMSS score from baseline at four weeks
|
to assess the non-motor of PD , 0-120 scores, the higher scores mean severe non-motor damage
|
changes of NMSS score from baseline at four weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cerebral blood variation by Head MRI
大体时间：changes of the cerebral blood from baseline at four weeks
|
to assess the cerebral blood variation by head MRI
|
changes of the cerebral blood from baseline at four weeks
|
|
cerebral blood flow velocity
大体时间：changes of the cerebral blood flow velocity from baseline at four weeks
|
cerebral blood flow velocity is recorded using transcranial Doppler and a servo-controlled plethysmograph respectively.
|
changes of the cerebral blood flow velocity from baseline at four weeks
|
|
the level of arterial blood pressure
大体时间：changes of the arterial blood pressure from baseline at four weeks
|
arterial blood pressure is recorded using transcranial Doppler and a servo-controlled plethysmograph respectively.
Both systolic and diastolic pressures will be assessed during the study period.
|
changes of the arterial blood pressure from baseline at four weeks
|
|
the concentration of microRNA in peripheral blood by gene chip
大体时间：changes of microRNA from baseline at four weeks
|
to test the the concentration of microRNA in peripheral blood
|
changes of microRNA from baseline at four weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Ying Zhang, Doctor、The First Hospital of Jilin University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年10月13日
初级完成 (预期的)
2021年10月30日
研究完成 (预期的)
2021年10月30日
研究注册日期
首次提交
2020年11月8日
首先提交符合 QC 标准的
2020年11月25日
首次发布 (实际的)
2020年12月3日
研究记录更新
最后更新发布 (实际的)
2021年1月5日
上次提交的符合 QC 标准的更新
2020年12月30日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.