UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034350 |
|---|---|
| Receipt number | R000039158 |
| Scientific Title | Evaluation of the effects on physical and cognitive functions in older adults after a dual-task exercise |
| Date of disclosure of the study information | 2018/10/17 |
| Last modified on | 2021/02/11 14:48:15 |
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Basic information
Public title
Evaluation of the effects on physical and cognitive functions in older adults after a dual-task exercise
Acronym
The effects of dual-task exercise
Scientific Title
Evaluation of the effects on physical and cognitive functions in older adults after a dual-task exercise
Scientific Title:Acronym
The effects of dual-task exercise
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Medicine in general | Not applicable | Adult |
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 older adults 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
Brain function (BDNF)
Key secondary outcomes
Oxidative stress (d-ROMs), Trail-making peg test, Timed up and go test, Five-times-sit-to stand movement test, 5-m habitual walk test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
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
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
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
(1) use of a pacemaker, (2) having an acute phase of a disease, (3) severe diabetes, (4) participation in strength training two or more times per week, or (5) an 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
Faculty of Health and sport science
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
Uiversity of Tsukuba
Address
1-2 KASUGA TSUKUBA IBARAKI
Tel
029-859-1593
yoon.jieun.fu@u@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
| 2018 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://paperchase-aging.s3-us-west-1.amazonaws.com/pdf/5f77201a9883a9000729dbab.pdf
Number of participants that the trial has enrolled
24
Results
This research represents the first evaluation of a gamelike DT exercise Synapsology (SYNAP). There was no significant difference between groups (Synapsology Group and Control Group) in this study. However, by participating in SYNAP, older adult participants exhibited positive changes in the TUG, TMPT, and d-ROMs but not in BDNF levels.
Results date posted
| 2021 | Year | 02 | Month | 11 | Day |
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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039158
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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