Back to resultsResearch on the Effect and Mechanism of Aerobic Exercise on PD
Primary Purpose
Parkinson's Disease, Physical Exercise
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Physical exercise, Mechanism
Eligibility Criteria
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)
Sites / Locations
- FirstJilinU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tremor group
Stiff group
Arm Description
Participants in the tremor group have tremor as the main clinical manifestation
Participants in the tremor group have stiff as the main clinical manifestation
Outcomes
Primary Outcome Measures
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
Montreal Cognitive Assessing(MoCA) score
to assess the cognitive function of PD,0-30 scores,the higher scores mean better function
The Epworth Sleeping Scale(ESS)
to assess the degree of drowsiness, 0-24 scores, the higher scores mean severe drowsiness
Non-Motor Symptom Scale (NMSS)
to assess the non-motor of PD , 0-120 scores, the higher scores mean severe non-motor damage
Secondary Outcome Measures
cerebral blood variation by Head MRI
to assess the cerebral blood variation by head MRI
cerebral blood flow velocity
cerebral blood flow velocity is recorded using transcranial Doppler and a servo-controlled plethysmograph respectively.
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.
the concentration of microRNA in peripheral blood by gene chip
to test the the concentration of microRNA in peripheral blood
Full Information
NCT ID
NCT04651140
First Posted
November 8, 2020
Last Updated
December 30, 2020
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT04651140
Brief Title
Research on the Effect and Mechanism of Aerobic Exercise on PD
Official Title
Research on the Effect and Mechanism of Aerobic Exercise on Parkinson's
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Physical Exercise
Keywords
Parkinson's Disease, Physical exercise, Mechanism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tremor group
Arm Type
Active Comparator
Arm Description
Participants in the tremor group have tremor as the main clinical manifestation
Arm Title
Stiff group
Arm Type
Active Comparator
Arm Description
Participants in the tremor group have stiff as the main clinical manifestation
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks
Primary Outcome Measure Information:
Title
Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
to assess the motor and nonmotor function of PD,0-200 scores,the higher scores mean lower function
Time Frame
changes of MDS-UPDRS score from baseline at four weeks
Title
Montreal Cognitive Assessing(MoCA) score
Description
to assess the cognitive function of PD,0-30 scores,the higher scores mean better function
Time Frame
changes of MoCA score from baseline at four weeks
Title
The Epworth Sleeping Scale(ESS)
Description
to assess the degree of drowsiness, 0-24 scores, the higher scores mean severe drowsiness
Time Frame
changes of ESS score from baseline at four weeks
Title
Non-Motor Symptom Scale (NMSS)
Description
to assess the non-motor of PD , 0-120 scores, the higher scores mean severe non-motor damage
Time Frame
changes of NMSS score from baseline at four weeks
Secondary Outcome Measure Information:
Title
cerebral blood variation by Head MRI
Description
to assess the cerebral blood variation by head MRI
Time Frame
changes of the cerebral blood from baseline at four weeks
Title
cerebral blood flow velocity
Description
cerebral blood flow velocity is recorded using transcranial Doppler and a servo-controlled plethysmograph respectively.
Time Frame
changes of the cerebral blood flow velocity from baseline at four weeks
Title
the level of arterial blood pressure
Description
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.
Time Frame
changes of the arterial blood pressure from baseline at four weeks
Title
the concentration of microRNA in peripheral blood by gene chip
Description
to test the the concentration of microRNA in peripheral blood
Time Frame
changes of microRNA from baseline at four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Zhang, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
Facility Information:
Facility Name
FirstJilinU
City
Changchun
ZIP/Postal Code
130021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Research on the Effect and Mechanism of Aerobic Exercise on PD
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