UMIN-CTR Clinical Trial

Basic information
Public title	Effect of mild exercise training on cognitive function in middle-aged and older adults
Acronym	Effect of mild exercise training on cognitive function in middle-aged and older adults
Scientific Title	Effect of mild exercise training on cognitive function in middle-aged and older adults
Scientific Title:Acronym	Effect of mild exercise training on cognitive function in middle-aged and older adults
Region	Japan

Condition
Condition	healthy middle-aged and older adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of a three-month very-low-intensity bicycle exercise program for healthy middle-aged and older adults on cognitive function and its neural and physiological mechanism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cognitive function, brain activity, brain structure, blood sample
Key secondary outcomes	mental health, cardiovascular function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	3-month very light intensity bicycle exercise program (30-50 min * 3 days / week)
Interventions/Control_2	No treatment
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	55 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	The person who: 1) is between 55 and 80 yrs. 2) is right-handed Japanese native speakers. 3) had normal or corrected-to-normal vision with normal color vision. 4) had not committed to any regular exercise in the previous 6 months. 5) naive to the experimental procedures for which they had volunteered.
Key exclusion criteria	1) had history of psychiatric or neurological disorders. 2) do not take any hormone therapies. 3) had history of cardiovascular disease or diabetes.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Soya
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Zip code	305-8574
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-2620
Email	soya.hideaki.gt@u.tsukuba.ac.jp

Public contact
Name of contact person	1st name Kazuki Middle name Last name Hyodo
Organization	Meiji Yasuda Life Foundation of Health and Welfare
Division name	Physical Fitness Research Institute
Zip code	192-0001
Address	150, Tobuki-cho, Hachioji-city, Tokyo
TEL	042-691-1163
Homepage URL
Email	k-hyodo@my-zaidan.or.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethcal committee of University of Tsukuba
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel	029-853-2571
Email	tg-kenkyurinri@un.tsukuba.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	筑波大学（茨城県）

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 04 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	110
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Because the data analysis has not yet been completed.
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	Completed
Date of protocol fixation	2013 Year 11 Month 01 Day
Date of IRB	2014 Year 02 Month 05 Day
Anticipated trial start date	2014 Year 02 Month 24 Day
Last follow-up date	2016 Year 03 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	2022 Year 11 Month 01 Day
Last modified on	2022 Year 11 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055959