Research on the Effect and Mechanism of Aerobic Exercise on PD

Not Applicable

• Conditions: Parkinson's Disease; Physical Exercise
• Interventions: Behavioral: aerobic exercise

• Registration Number: NCT04651140
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

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

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

Study Timeline

• Study Start: 2020-10-13
• Status Verified: 2020-11
• Study First Submitted: 2020-11-08
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-03
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tremor group	aerobic exercise	Participants in the tremor group have tremor as the main clinical manifestation
Stiff group	aerobic exercise	Participants in the tremor group have stiff as the main clinical manifestation

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessing(MoCA) score	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
Non-Motor Symptom Scale (NMSS)	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
The Epworth Sleeping Scale(ESS)	changes of ESS score from baseline at four weeks	to assess the degree of drowsiness, 0-24 scores, the higher scores mean severe drowsiness
Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS)	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

Secondary Outcome Measures

Name	Time	Method
the level of arterial blood pressure	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.
the concentration of microRNA in peripheral blood by gene chip	changes of microRNA from baseline at four weeks	to test the the concentration of microRNA in peripheral blood
cerebral blood variation by Head MRI	changes of the cerebral blood from baseline at four weeks	to assess the cerebral blood variation by head MRI
cerebral blood flow velocity	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.

Trial Locations

Locations (1)

FirstJilinU; 🇨🇳 Changchun, China