UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038712 |
|---|---|
| Receipt number | 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 | 2023/02/05 18:14:19 |
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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
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
yoon.jieun.fu@u.tsukuba.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
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
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
https://alz-journals.onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.12276
Publication of results
Published
Result
URL related to results and publications
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12276
Number of participants that the trial has enrolled
24
Results
A comparison of the Mini-Mental State Examination scores and six physical function tests, before and after the intervention, shows that the SYNAP had a positive impact on the cognitive and physical functions among the intervention group. These finding ssuggest that SYNAP may help maintain or improve cogni-tive and physical functions among older adults compared to no interventions. Therefore, SYNAP would act as a beneficial tool amidst a superaging society like Japan.
Results date posted
| 2023 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants (aged 85-97 yaears) were assogned to the intervention group (n = 12) and the control group (n = 12)
Participant flow
The interventi on group underwent 60-minute sessions, twicea week for 24weeks.
Adverse events
None
Outcome measures
Mini-Mental State Examination scores
48-peg miving tast
5-times sit-to stand
6-m hapitual walk
TUG
One-leg balance with eyes open
Grip strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2023 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044107
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| Registered date | File name |
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