UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037208 |
|---|---|
| Receipt number | R000042424 |
| Scientific Title | Effects of dual-task walking program on cognitive functions in the older adults with mild cognitive impairment: a randomized controlled trial |
| Date of disclosure of the study information | 2019/07/11 |
| Last modified on | 2019/06/28 20:27:20 |
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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
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
sho-n@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042424
