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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038712
Receipt No. R000044107
Scientific Title Evaluation of the effects on physical and cognitive functions in Oldest-old after a dual-task exercise
Date of disclosure of the study information 2019/11/28
Last modified on 2019/11/28

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Basic information
Public title Evaluation of the effects on physical and cognitive functions in Oldest-old after a dual-task exercise
Acronym The effects of dual-task exercise in oldest-old
Scientific Title Evaluation of the effects on physical and cognitive functions in Oldest-old after a dual-task exercise
Scientific Title:Acronym The effects of dual-task exercise in oldest-old
Region
Japan

Condition
Condition None
Classification by specialty
Hepato-biliary-pancreatic medicine Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect on physical and cognitive functions in oldest-old after a dual-task exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mini-Mental State Examination
Key secondary outcomes Grip strength, One leg balance with eyes open, 6-m habitual walk, timed up and go, 5-times sit-to stand, peg moving task

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise
Interventions/Control_2 Daily Life
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
85 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Participants is fully informed about the study and has signed the information consent form
(2) Participant who gets motivated to this study
Key exclusion criteria Inability to attend the study briefing or continuously attend the training sessions
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name OKURA
Organization University of Tsukuba
Division name Faculty of Health and sport science
Zip code 305-8550
Address 1-2 KASUGA TSUKUBA IBARAKI
TEL 0298591593
Email yoon.jieun.fu@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Jieun
Middle name
Last name YOON
Organization Uiversity of Tsukuba
Division name R&D Center for Tailor-Made QOL
Zip code 305-8550
Address 1-2 KASUGA TSUKUBA IBARAKI
TEL 0298591593
Homepage URL
Email yoon.jieun.fu@u.tsukuba.ac.jp

Sponsor
Institute Japan Science and Technology Agency
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization University of Tsukuba
Address 1-1-1, Tennodai, Tsukuba, Ibaraki
Tel 029-853-2571
Email hitorinri@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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 28 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 24
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 Completed
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
2017 Year 02 Month 16 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2019 Year 05 Month 29 Day
Date of closure to data entry
2019 Year 05 Month 30 Day
Date trial data considered complete
2019 Year 06 Month 01 Day
Date analysis concluded
2019 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 11 Month 28 Day
Last modified on
2019 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044107

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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