UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061538 |
|---|---|
| Receipt number | R000067870 |
| Scientific Title | Fluctuations in Exercise Motivation According to Music Tempo in Older Adults Attending a Day-Care Center: A Time-Series Micro-Randomized Trial |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/12 14:35:40 |
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Basic information
Public title
Fluctuations in Exercise Motivation According to Music Tempo in Older Adults Attending a Day-Care Center: A Time-Series Micro-Randomized Trial
Acronym
Fluctuations in Exercise Motivation According to Music Tempo in Older Adults Attending a Day-Care Center: A Time-Series Micro-Randomized Trial
Scientific Title
Fluctuations in Exercise Motivation According to Music Tempo in Older Adults Attending a Day-Care Center: A Time-Series Micro-Randomized Trial
Scientific Title:Acronym
Fluctuations in Exercise Motivation According to Music Tempo in Older Adults Attending a Day-Care Center: A Time-Series Micro-Randomized Trial
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, pre-exercise music sessions at the day-care center will be randomly assigned each day to either an up-tempo or a slow-tempo condition, and exercise motivation will be assessed immediately after the music in a time-series framework. The aim is to empirically elucidate the short-term psychological activation effects of music tempo and to establish a simple, non-pharmacological intervention model for enhancing motivation during the initial phase of rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise Motivation Numeric Rating Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
high tempo 150bpm music
Interventions/Control_2
normal tempo 80bpm music
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria
Individuals aged 65 years or older
Individuals with a Clinical Dementia Rating (CDR) of 0.5 or higher
Key exclusion criteria
Individuals with neurological diseases
Individuals with severe hearing impairment
Individuals with frontotemporal dementia
Individuals with psychiatric disorders other than dementia
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Nakaguchi |
Organization
Hoshino clinic
Division name
rehabilitation
Zip code
640-8342
Address
5-32 Tomodacho, Wakayama City, Wakayama Prefecture, Japan
TEL
08075349651
nakaguchi.pt@gmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Nakaguchi |
Organization
Hoshino clinic
Division name
Rehabilitation
Zip code
6408342
Address
5-32 Tomodacho, Wakayama City, Wakayama Prefecture, Japan
TEL
08075349651
Homepage URL
nakaguchi.pt@gmail.com
Sponsor or person
Institute
Hoshino clinic
Institute
Department
Personal name
Funding Source
Organization
Hoshino clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka College of Medical and Welfare
Address
1-2-14 Miyahara, Yodogawa-ku, Osaka City, Osaka Prefecture 532-0003, Japan
Tel
08075349651
nakaguchi.pt@gmail.com
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
| 2026 | Year | 05 | Month | 15 | 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
18
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
| 2026 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067870
