Research on the Effect and Mechanism of Aerobic Exercise on PD

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

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease; Physical Exercise
• Intervention / Treatment: Behavioral: aerobic exercise

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Changchun, China, 130021
    • FirstJilinU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Study Director: Ying Zhang, Doctor, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: November 8, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Physical exercise; Mechanism
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Zhang Ying

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No