Validation of exercise effects in patients with Parkinson disease.

JRCT ID: jRCT1030220416

Registered date:27/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 27/10/2022
• Target sample size: 120
• Study type: Interventional

Intervention(s)

We will destribute activity tracker (acti graph) to recruited and randomized patients with Parkinson disease.
Group of exercise; DVD exercise (about 30minutes) and 20 minutes walking at least 5 times/ a week.
Group of no exercise / sedentary; Usual daily living activity.
We will measure activity 1month (+/-2 weeks) before as a baseline and 1,3,6,9 month after starting exercise. We will keep the score of clinical evaluation, collect patients blood samples and measure candidate neuroprotective factors mentioned below with the period of 1month (+/-2 weeks) before and 1,3,6,9 month after starting exercise.

Outcome(s)

• Primary Outcome: Protein and mRNA amount of mitochondrial protein deacetylase SIRT3 in blood samples of randomly assigned patients in exercise and no exercise group.

Secondary Outcome

Clinical evaluation; MDS-UPDRS part 3 (movement function scale), MMSE (dementia scale), HAMD (depression scale), non-motor symptoms assessment scale (NMSS).
Candidate neuroprotective factors; anti-alpha synuclein antibody, Brain-derived neurotrophic factor (BDNF), Vascular endothelial growth factor (VEGF), DNA methylase 1 (Dnmt1), alpha-synuclein DNA methylation rate.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Patient (Hoehn and Yahr I,II) with diagnosis of Parkinson disease according to the 2015 MDS (International Parkinson and Movement Disorder Society) crinical diagnostic criteria of Parkinson disease.
2. Able to come to Juntendo University Koshigaya hospital regularly during the study period.
3. Older than 40 years old and yonger than 80 years old with no dementia criteria of a MMSE at a baseline >= 26.

Exclude criteria

1.Yonger than 39 years old and older than 81 years old.
2.Patient with diagnosis of cerebrovascular disease, neuroimmunological disease, seizure disorder and neurodegenerative disease, such multiple system atrophy, progressive supranuclear pulsy and Alzheimer disease.
3.Patient with an abnormal ECG or past medical history of coronary infarction. Patient with an obvious orthostatic hypotension.
4.Patient with a hepatic disorder, a renal disorder and malignancy.
5.Others that investigators judged inappropriate.

Related Information

• Primary Sponsor: Ando Maya
• Source(s) of Monetary Support: Japan society for the promotion of science, Grants-in-Aid for scientific research