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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035008
Receipt No. R000039891
Scientific Title Effect of physical activity on gut microbiota
Date of disclosure of the study information 2018/11/26
Last modified on 2019/05/29

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Basic information
Public title Effect of physical activity on gut microbiota
Acronym PA microbiota
Scientific Title Effect of physical activity on gut microbiota
Scientific Title:Acronym PA microbiota
Region
Japan

Condition
Condition Adluts
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 examine the effect of physical activity on gut microbiota
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes gut microbiota
Key secondary outcomes muscle strength, endurance, body composition, blood parameters

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 moderate intensity of aerobic exercise, three sessions per week for 6 weeks
Interventions/Control_2 sedentary time
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria -Adults whose age is less than 80 years
-no severe chronic diseases
Key exclusion criteria -engage in routine exercise program at least twice every week
-took antibiotic agents within 3 months
-prohibit from exercise
-take probiotics
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Toshiaki
Middle name
Last name MIyamoto
Organization Hyogo University of Health Sciences
Division name School of Rehabilitation
Zip code 6508530
Address 1-3-6, Minatojima, Chuo-ku, Kobe, Japan
TEL 0783043073
Email t-miyamoto@huhs.ac.jp

Public contact
Name of contact person
1st name Toshiaki
Middle name
Last name Miyamoto
Organization Hyogo University of Health Sciences
Division name School of Rehabilitation
Zip code 6508530
Address 1-3-6, Minatojima, Chuo-ku, Kobe, Japan
TEL 0783043073
Homepage URL
Email t-miyamoto@huhs.ac.jp

Sponsor
Institute Hyogo University of Health Sciences
Institute
Department

Funding Source
Organization Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hyogo University of Health Sciences
Address 1-3-6, Minatojima, Chuo-ku, Kobe, Japan
Tel 0783043073
Email t-miyamoto@huhs.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
2018 Year 11 Month 26 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039891

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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