UMIN-CTR Clinical Trial

Basic information
Public title	A randomized control trial of walking program for cognitive functions in the older adults
Acronym	A randomized control trial of walking program for cognitive functions in the older adults
Scientific Title	Effects of dual-task walking program on cognitive functions in the older adults with mild cognitive impairment: a randomized controlled trial
Scientific Title:Acronym	A randomized control trial for preventing decline of cognitive functions in the older adults with MCI
Region	Japan

Condition
Condition	Mild cognitive impairment
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effects of dual task pole walking on cognitive decline in elderly with mild cognitive impairment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	cognitive function: memory, attention, executive function, processing speed, special recognition, working memory
Key secondary outcomes	physical function (muscle strength, walking speed, endurance), self-rated health, psychological state (depressive symptoms), ability to do dual task , life style factor (drinking habit, smoking habit, sleep, physical activity, life space, leisure activity), neuroimaging

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	dual task pole walking for 6 months
Interventions/Control_2	control group: lecture about disease and health (1 time during 6 months)
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	65 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Elderly people, aged 65 over and living in community, having health check from January to February, 2019. 2) Fullfilled following MCI criteria (a: cognitive function is 1.5 SD or more below the normative values; b: not diagnosed dementia; c: being independent in activity of daily living) 3) Being agreed with participation in the study
Key exclusion criteria	1) with serious or unstable illnesses 2) history of neurodegenerative disease psychiatric disease 3) receiving of anti-Alzheimer drugs 4) needing long-term care
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Shimada
Organization	National Center for Geriatrics and Gerontology
Division name	Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430 Morioka-cho, Obu city, Aichi
TEL	0562-87-1285
Email	shimada@ncgg.go.jp

Public contact
Name of contact person	1st name Sho Middle name Last name Nakakubo
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
Zip code	474-8511
Address	7-430 Morioka-cho, Obu city, Aichi
TEL	0562-87-1285
Homepage URL
Email	sho-n@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research and Medical Division
Address	7-430 Morioka-cho Obu city, Aichi prefecture, Japan
Tel	0562-46-2311
Email	yaday@ncgg.go.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	2019 Year 07 Month 11 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	Preinitiation
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2019 Year 04 Month 08 Day
Anticipated trial start date	2019 Year 07 Month 11 Day
Last follow-up date	2020 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	2019 Year 06 Month 28 Day
Last modified on	2019 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042424