UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect of activity level on innate immunity
Title of the study (Brief title)	Relationship between exercise volume and innate immunity
Region	Japan

Condition
Condition	adults aged 20 to 80
Classification by specialty	Clinical immunology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between activity level and innate immunity
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Leukocyte fraction, cytokine, salivary protein
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Those who agree with the purpose of this research
Key exclusion criteria	Nothing in particular
Target sample size	140

Research contact person
Name of lead principal investigator	Akama Takao
Organization	Waseda university
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama
TEL	04-2947-6721
Email	takao-akama@waseda.jp

Public contact
Name of contact person	Hanaoka Yukichi
Organization	Waseda university
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama
TEL	04-2947-6721
Homepage URL
Email	hanakichi3@gmail.com

Sponsor
Institute	Faculty of Sport Sciences, Waseda university
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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 04 Month 26 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Nothing in particular

Management information
Registered date	2017 Year 08 Month 01 Day
Last modified on	2018 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032593