UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060404 |
|---|---|
| Receipt number | R000069104 |
| Scientific Title | Effects of Dance Program Interventions on Functional Ability in Healthy Older Adults: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/19 20:44:24 |
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Basic information
Public title
Effects of Dance Program Interventions on Functional Ability in Healthy Older Adults: A Randomized Controlled Trial
Acronym
Effects of Dance Program Interventions on Functional Ability in Healthy Older Adults
Scientific Title
Effects of Dance Program Interventions on Functional Ability in Healthy Older Adults: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Dance Program Interventions on Functional Ability in Healthy Older Adults
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of singing and dance interventions on motor functions - such as muscle strength, balance, flexibility, and walking ability - as well as on swallowing function in older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Timed Up and Go Test, Maximum Phonation Time
Key secondary outcomes
grip strength, knee extension strength, Functional Reach Test, Four Square Step Test, Pa/Ta/Ka test, tongue pressure, Repetitive Saliva Swallowing Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The dance intervention group will participate in a dance program three times per week for four weeks
Interventions/Control_2
The non-intervention group will continue their usual daily activities for four weeks
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) Individuals (male or female) aged >=65 years at the time of consent
(2) Individuals who voluntarily provide informed consent to participate in the study
(3) Individuals who are able to attend the intervention facility three times per week for four weeks at the designated dates and times and perform the dance intervention if allocated to the intervention group
Key exclusion criteria
(1) Individuals who use life supporting medical devices such as cardiac pacemakers or physiological monitoring devices
(2) Individuals who engage in regular exercise for more than one hour per week
(3) Individuals who require the use of a cane in daily life
(4) Individuals who are blind or deaf
(5) Individuals who are undergoing treatment for diseases that may affect the study results, or those who may develop a disease or symptoms as a result of exercise
(6) Individuals judged by the investigators to be unable to complete the intervention or assessments
(7) Individuals deemed unable to undergo the intervention or assessments at the discretion of the investigators
(8) Individuals who are scheduled or likely to be hospitalized or undergo surgery during or after the intervention period, or those who are expected to begin any medical treatment during the intervention period
(9) Individuals who may be at risk of developing an allergic reaction related to the study
(10) Individuals who are participating in other clinical studies, clinical trials, or human research at the time of consent, or those who are scheduled to participate in such studies during the intervention period
(11) Individuals deemed unsuitable as study participants based on their lifestyle questionnaire responses
(12) Individuals who are otherwise judged inappropriate as study participants by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Shimizu |
Organization
Avex Music Creative Inc.
Division name
Planning and Development Group
Zip code
108-0073
Address
1-4-1 Mita, Minato-ku, Tokyo, Japan
TEL
03-6714-5180
shimizu-kei@av.avex.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimura |
Organization
EP Mediate Co., Ltd.
Division name
Development Department
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
080-1193-3234
Homepage URL
yoshimura.kaori265@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Avex Music Creative Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.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
メディカルステーションクリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 19 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 01 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069104
