UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047106 |
|---|---|
| Receipt number | R000053736 |
| Scientific Title | A longitudinal study to examine the effect of leisure activity on cognitive function among older adults |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2025/05/20 17:50:32 |
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Basic information
Public title
A longitudinal study to examine the effect of leisure activity on cognitive function among older adults
Acronym
A longitudinal study to examine the effect of leisure activity on cognitive function among older adults
Scientific Title
A longitudinal study to examine the effect of leisure activity on cognitive function among older adults
Scientific Title:Acronym
The effect of leisure activity on cognitive function among older adults
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines whether participating dance program enhances cognitive function among older adults including MCI. The objectives of this study are to examine 1) raising secretional capacity of oxytocin, 2) changing brain structure and function, and 3) changing volume of brain activation and functional connectivity during cognitive task.
Additionally, we characterize neurophysiological foundations and relationship between leisure activities and cognitive function measuring brain function and activity by 3T-MRI.
Basic objectives2
Others
Basic objectives -Others
Examining the effect of leisure activities
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
a)Scores of cognitive assessments (Moca and Rivermead Memory Test) measured at pre-test and post-test.
b)Oxytocin and 5-HIAA in saliva and urine measured at pre-test and post-test.
c)Cerebellar gray matter volume measured at pre-test and post-test.
d)Volume of brain activation and functional connectivity during n-back task.
Key secondary outcomes
a)Correlations between scores of cognitive assessments and subjective wellbeing assessed by psychological scales.
b)Correlations between variations of oxytocin,5-HIAA, and cerebellar gray matter volume.
c)Correlations between variations of cerebellar gray matter volume and scores of cognitive assessments.
d)Correlations between variations of volume of brain activation, brain functional connectivity, and scores of cognitive assessments.
e)Correlations between oxytocin, 5-HIAA, volume of brain activation, and brain functional connectivity measured at pre-test.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: After the pre-test, the participants participate in a dance program for three months. After completing the dance program, the post-test will conduct.
Interventions/Control_2
Control:After the pre-test, the participants wait for three months. After the post-test, the participants participate in a dance program for three 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.A person diagnosed as MCI (memory disorder that is unexplainable by aging and educational level) by a medical doctor in psychiatry or neurology, or a person scored over 24 in MMSE and over 6 in The Lawton Instrumental Activities of Daily Living (IADL) Scale.
2.A person who reports to forget things.
3.A person who is able to go places to test and participate dance classes.
Key exclusion criteria
1.A person who is unsuitable for MRI scan (e.g., having a metallic device in body).
2.A person with a claustrophobia or panic disorder.
3.A left-handed person, or a both-handed person.
4.A person who takes sleeping pills or psychoactive drugs.
5.A person suspected dementia (scored under 23 in MMSE).
6.A person with heart disease.
7.A person who has discovered an aberrant image of the brain that influences cognitive function.
8.A person with a neurological disorder (e.g., parkinsonism) excepted MCI.
9.A person has a medical history of mental disease (e.g., depression).
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Sekiyama |
Organization
Kyoto University
Division name
Graduate School of Advanced Integrated Studies in Human Survivability
Zip code
606-8306
Address
1 Nakaadachi-cho, Yoshida, Sakyo-ku, Kyoto, JAPAN
TEL
075-762-2273
sekiyama.kaoru.8a@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Toyoshima |
Organization
Shimane University
Division name
Faculity of Human Sciences
Zip code
690-8504
Address
1060,Nishikawatsu-cho, Matsue-shi, Shimane, JAPAN
TEL
070-5575-3059
Homepage URL
aya.t.6395@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Prefectural University of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School of Medicine, Ethics Committee
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2022 | Year | 03 | Month | 07 | 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
69
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. This study targeted older adults with mild cognitive impairment(MCI).However, the recruitment period coincided with the COVID-19 pandemic, preventing us from recruiting individuals diagnosed with MCI by a medical doctor.
2. The results of both the MMSE-J and MoCA-J were conducted in this study raised doubts about using MMSE-J <= 23 as the criterion for suspicion of dementia (Iwasaki et al, 2025). In a recent study (Fastame, 2022), the original cutoff point (21/20) was used, and the decision was made with reference to the values of the MoCA-J and IADL scores, rather than solely on the basis of MMSE-J <= 23.
References
Iwasaki S, Yamashita M, Takamatsu R, Toyoshima A, Nishiguchi S, Yamada M, & Sekiyama K. Converting MOCA-J to MMSE-J in Community-Dwelling Japanese Older Adults: A Pilot Study. Psychologia, 2025, Advance online publication. https://doi.org/10.2117/psysoc.2023-B046
Fastame MC. Are subjective cognitive complaints associated with executive functions and mental health of older adults?. Cogn Process. 2022;23(3):503-512. doi:10.1007/s10339-022-01089-y
Management information
Registered date
| 2022 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053736
