Research on the Effect and Mechanism of Aerobic Exercise on PD

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Research on the Effect and Mechanism of Aerobic Exercise on Parkinson's

Conditions
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Parkinson's Disease, Physical Exercise

Intervention / Treatment
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* Behavioral: aerobic exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tremor group<br>Participants in the tremor group have tremor as the main clinical manifestation | Behavioral: aerobic exercise<br>* Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks<br>|
| Active Comparator: Stiff group<br>Participants in the tremor group have stiff as the main clinical manifestation | Behavioral: aerobic exercise<br>* Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS) | 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 | 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) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral blood variation by Head MRI | to assess the cerebral blood variation by head MRI | changes of the cerebral blood from baseline at four weeks | 
| cerebral blood flow velocity | 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 | 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 | to test the the concentration of microRNA in peripheral blood | changes of microRNA from baseline at four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Physical exercise, Mechanism