UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059250 |
|---|---|
| Receipt number | R000060999 |
| Scientific Title | A Yoga Therapy Approach to Physical and Mental Health and Mild Cognitive Impairment (MCI) in the Elderly: Using Motion Analysis and Psychological Data Analysis |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/30 22:23:32 |
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Basic information
Public title
How to help older people and those with mild cognitive symptoms achieve physical and mental health through yoga therapy: using exercise and psychosocial analysis
Acronym
How to help older people and those with mild cognitive impairment (MCI) achieve physical and mental health through yoga therapy: using exercise and psychosocial analysis
Scientific Title
A Yoga Therapy Approach to Physical and Mental Health and Mild Cognitive Impairment (MCI) in the Elderly: Using Motion Analysis and Psychological Data Analysis
Scientific Title:Acronym
A Yoga Therapy Approach to Physical and Mental Health and Mild Cognitive Impairment (MCI) in the Elderly: Using Motion Analysis and Psychological Data Analysis
Region
| Japan |
Condition
Condition
yes elderly and mild cognitive
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study reveals the psychological impact of yoga therapy on older people and mild cognitive impairment (MCI) and its associated movement changes. And to validate effective therapeutic programs.
Basic objectives2
Others
Basic objectives -Others
Based on the results of the assessments performed, a program incorporating yoga techniques for older people was developed, and the therapy was conducted. The effects of yoga therapy on psychological and physiological aspects, such as improvement of the participants' mood (e.g., vigor) and changes in movement, will be verified by comparing the results of psychological tests and movement analysis before and after the therapy. Targeted older people will be invited to participate in the therapy and interviewed to verify the psychological effects, and changes in cognitive function will also be examined. In addition, the relationship between psychology and movement will be verified by filming the therapy practice and analyzing their movements.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Improve MMSE before and after practice assessment results before- and after-session using MMSE( Mini-Mental State Examination )
PGC (Philadelphia Geriatric Center Morale Scale)
Key secondary outcomes
Changes in the Revised PGC Morality Scale (a test to measure QOL and satisfaction of older people), the Baum test (to analyze cognition based on the drawing method, etc.), and the Open Pose movement analysis (filmed by a video camera) before and after the practice assessment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
As yoga therapy, western yoga, pranayama, and meditation after obtaining a certificate of assessment.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy older people who are residents of nursing facilities, who have not received a diagnosis of physical or mental illness, and who were not physically or mentally unwell at the time of participation in the experiment were used as participants.
Key exclusion criteria
Persons were excluded from the participant list if they suffered from a physical or mental illness or if they demonstrated psychological discomfort prior to or during their participation in the therapy. Additionally, those with a total score of less than 23 on the MMSE (Mental State Examination) administered during the evaluation will be excluded from being a subject. (A score of 27 or less is considered Mild Cognitive Impairment (MCI), and a score of 23 or less is considered dementia.)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | KATO |
Organization
Toyo University
Division name
Faculty of Information Sciences and Arts
Zip code
350-0815
Address
2100 Kujirai, Kawagoe-shi, Saitama
TEL
049-239-1434
Kato-c@toyo.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | MURAKAMI |
Organization
Toyo University Graduate School
Division name
Graduate School of Information Sciences and Arts
Zip code
350-0815
Address
2100 Kujirai, Kawagoe-shi, Saitama
TEL
090-4556-7977
Homepage URL
s4b102210031@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Ethics Review Committee for Medical Research Involving Human Subjects at Toyo University
Address
2100 Kujirai, Kawagoe-shi, Saitama
Tel
049-239-1440
mlkks@toyo.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
| 2025 | Year | 09 | Month | 30 | 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
25
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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060999
