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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039705
Receipt No. R000039740
Scientific Title Effectiveness of mild exercise for high functioning Autism Spectrum Disorder
Date of disclosure of the study information 2020/03/05
Last modified on 2020/03/05

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Basic information
Public title Effectiveness of mild exercise for high functioning Autism Spectrum Disorder
Acronym Effectiveness of mild exercise for high functioning Autism Spectrum Disorder
Scientific Title Effectiveness of mild exercise for high functioning Autism Spectrum Disorder
Scientific Title:Acronym Effectiveness of mild exercise for high functioning Autism Spectrum Disorder
Region
Japan

Condition
Condition high functioning Autism Spectrum Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to examine whether mild exercise is more effective than treatment as usual for high functioning Autism Spectrum Disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BACS
WCST
Key secondary outcomes SRS
CAARS
BIS/BAS
HQ-25+4
BPNFSF
AASP
near infrared spectroscopy
MRI
electroencephalogram
macrophage
physical function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 mild exercise
Interventions/Control_2 once a day for 10 minutes, 30 days
Interventions/Control_3
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
18 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Participants are diagnosed with autism Spectrum Disorder according to ADOS-2.
Key exclusion criteria mental retardation
history of drug or alcohol abuse
organic central nervous system disorder
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Matsuda
Organization Nara Medical University School of Medicine
Division name Department of Psychiatry
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL 0744-22-3051
Email yasumatsuda319@hotmail.com

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Matsuda
Organization Nara Medical University School of Medicine
Division name Department of Psychiatry
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL 0744-22-3051
Homepage URL
Email yasumatsuda319@hotmail.com

Sponsor
Institute Nara Medical University School of Medicine, Department of Psychiatry
Institute
Department

Funding Source
Organization KAKENHI
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nara Medical University School of Medicine
Address 840 Shijo-cho, Kashihara, Nara
Tel 0744-22-3051
Email smuraka@naramed-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 05 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
2019 Year 03 Month 18 Day
Date of IRB
2019 Year 03 Month 18 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2023 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
2020 Year 03 Month 05 Day
Last modified on
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039740

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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