UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059456 |
|---|---|
| Receipt number | R000067983 |
| Scientific Title | Effects of Face Yoga on the Well-Being of Middle-Aged and Older Women |
| Date of disclosure of the study information | 2025/10/24 |
| Last modified on | 2025/10/19 17:33:59 |
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Basic information
Public title
Effects of Face Yoga on Well-being in Middle-aged Women
Acronym
Face Yoga Well Study
Scientific Title
Effects of Face Yoga on the Well-Being of Middle-Aged and Older Women
Scientific Title:Acronym
Face Yoga Well Study
Region
| Japan |
Condition
Condition
Healthy middle-aged women
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of face yoga on psychological well-being and physical health in middle-aged women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Changes in psychological indicators (POMS2), physical indicators (oral and swallowing function measurements), and subjective facial expression evaluation (VAS) before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A facial yoga program focusing on facial muscles will be conducted for middle-aged women.
The intervention will last for two months. Participants will practice facial yoga at home for 5 minutes daily while watching instructional videos.
In addition, a 30-minute online group lesson will be provided once a week during the intervention period.
Participants will be instructed in facial yoga, including facial muscle stretching and training, breathing techniques, and other methods.
Psychological indicators (POMS2), physical indicators (oral and swallowing function), and subjective evaluation of facial expression (VAS) will be measured before and after the intervention to assess the effects of facial yoga.
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
This study targets middle-aged women, who constitute the majority of facial yoga participants.
Since middle age is a period when facial muscle strength and oral-swallowing functions gradually decline, this study aims to promote the habitual practice of facial yoga before the onset of functional deterioration, in order to maintain and improve mental and physical well-being.
Therefore, the inclusion criteria are healthy middle-aged women who are able to perform daily activities independently.
Key exclusion criteria
Participants who meet any of the following conditions will be excluded:
1.Presence of severe mental disorders
2.Presence of severe oral diseases, neuromuscular disorders, or motor disabilities
3.Use of medications or treatments (such as muscle relaxants) that may affect muscle activity
4.Individuals who routinely practice facial yoga or similar facial muscle training
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Tanaka |
Organization
Kyoto Koka Women's University
Division name
Graduate School of Nursing
Zip code
615-0882
Address
38 , NishikyogokuKadono-cho, Ukyo Ward, Kyoto City
TEL
075-366-2671
s24mm03@owa.koka.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Tanaka |
Organization
Kyoto Koka Women's University
Division name
Graduate School of Nursing
Zip code
615-0882
Address
38 , NishikyogokuKadono-cho, Ukyo Ward, Kyoto City
TEL
075-366-2671
Homepage URL
s24mm03@owa.koka.ac.jp
Sponsor or person
Institute
Kyoto Koka Women's University
Institute
Department
Personal name
Masako Tanaka
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Koka Women's University
Address
38 , NishikyogokuKadono-cho, Ukyo Ward, Kyoto City
Tel
075-325-5136
s24mm03@owa.koka.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
京都光華女子大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 24 | 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
30
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
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 19 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067983
