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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026127
Receipt No. R000030021
Scientific Title Study of the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease
Date of disclosure of the study information 2017/02/14
Last modified on 2019/03/19

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Basic information
Public title Study of the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease
Acronym Cognitive function intervention of Parkinson's disease
Scientific Title Study of the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease
Scientific Title:Acronym Cognitive function intervention of Parkinson's disease
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive function
Key secondary outcomes white matter integrity, depression, apathy, sleep disorders, arousal disorder, pain, fatigue, motor symptom, posture, and QOL.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Aerobic exercise
60 min per day, 2 days per week
added to conventional rehabilitation
Interventions/Control_2
Interventions/Control_3 Conventional rehabilitation only
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) not dementia
2) H&Y stage 2-3
Key exclusion criteria Patients who are complicated with other disease to influence a motor function, a cognitive function
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kohei
Middle name
Last name Marumoto
Organization Hyogo Prefectural Rehabilitation Hospital at Nishi - Harima
Division name Department of Physical Medicine and Rehabilitation
Zip code 679-5165
Address 1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo
TEL 0791-58-1050
Email k.maru5081@gmail.com

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Marumoto
Organization Hyogo Prefectural Rehabilitation Hospital at Nishi - Harima
Division name Department of Physical Medicine and Rehabilitation
Zip code 679-5165
Address 1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo
TEL 0791-58-1050
Homepage URL
Email k.maru5081@gmail.com

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)Grant-in-Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo Prefectural Rehabilitation Hospital at Nishi - Harima
Address 1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo
Tel 0791-58-1050
Email k.maru5081@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 兵庫県立リハビリテーション西播磨病院

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
2014 Year 07 Month 24 Day
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 14 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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