Research on the Effect and Mechanism of Aerobic Exercise on PD

• Sponsor: The First Hospital of Jilin University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04651140
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.6
• Patients Per Site Per Month: 2.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease; Physical Exercise	Behavioral: aerobic exercise	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Research on the Effect and Mechanism of Aerobic Exercise on Parkinson's
• Actual Study Start Date: Oct 13, 2020
• Anticipated Primary Completion Date: Oct 30, 2021
• Anticipated Study Completion Date: Oct 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

Secondary Outcome Measures

1. 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

2. 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.

3. 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.

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FirstJilinU	Changchun		China	130021

Sponsors and Collaborators

• The First Hospital of Jilin University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhang Ying, Professor, The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT04651140
• Other Study ID Numbers: Zhang Ying
• First Posted: Dec 3, 2020
• Last Update Posted: Jan 5, 2021
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhang Ying, Professor, The First Hospital of Jilin University: Parkinson's Disease; Physical exercise; Mechanism
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Jan 5, 2021