Research on the Effect and Mechanism of Aerobic Exercise on PD

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04651140
• Other study ID #: Zhang Ying
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2020
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Physical Exercise

Intervention

Behavioral:
• aerobic exercise
Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks

Locations

Country	Name	City	State
China	FirstJilinU	Changchun

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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