UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045745 |
|---|---|
| Receipt number | R000052212 |
| Scientific Title | Difference in Effectiveness of Interoceptive and Non-Interoceptive Yoga |
| Date of disclosure of the study information | 2021/10/13 |
| Last modified on | 2026/04/18 09:03:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Impact of Physical Awareness on Effectiveness of Yoga
Acronym
Impact of Physical Awareness on Effectiveness of Yoga
Scientific Title
Difference in Effectiveness of Interoceptive and Non-Interoceptive Yoga
Scientific Title:Acronym
Difference in Effectiveness of Interoceptive and Non-Interoceptive Yoga
Region
| Japan |
Condition
Condition
Healthy Students
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effect of yoga on mind and body. Investigating the difference in the effect on mind and body of yoga exercises conducted with or without interoceptive awareness. Examining the elements of yoga which produce said effect.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Assessment results before- and after-session using STAI, POMS2, FACES scale (body temperature, skin temperature, heart rate, heart rate variability, headache, stiff shoulders, eye fatigue, tiredness, anxiety, calmness, heaviness of the body, concentration, awareness of mind and body, safety, freely described impressions)
Key secondary outcomes
MAIA (Multidimensional Assessment of Interoceptive Aware-ness), YG personality test, FFMQ (mindfulness scale), SHS (subjective well-being scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Yoga/Exercising1 (approximately 30 minutes practicing awareness, using mindfulness techniques of interoceptive awareness)
The experiment will be regularly conducted - once a week for 6 or 10 consecutive weeks (depending on the participant's availability).
Interventions/Control_2
Yoga/Exercising 2
Conducted once a week for 3 consecutive weeks, approximately 30 minutes without practicing awareness of interoceptive awareness; then yoga/exercising is conducted practicing awareness for 3 or 7 consecutive weeks (depending on the participant's availability).
Interventions/Control_3
Light exercising (participants individually choose and conduct the same content for approximately 15 minutes) is conducted once a week for 3 consecutive weeks. Then yoga/exercising is conducted practicing awareness for 3 or 7 consecutive weeks (depending on the participant's availability).
Interventions/Control_4
Rest (participants sit on chairs and rest for approximately 15 minutes)is conducted once a week for 3 consecutive weeks. Then yoga/exercising is conducted practicing awareness for 3 or 7 consecutive weeks (depending on the participant's availability).
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
University students (who equally meet various conditions such as physical strength and cognitive ability) who are in good health
and have no yoga experience
Key exclusion criteria
People with mental illness; people with chronic conditions which might worsen suddenly
Target sample size
50
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
350-8585
Address
2100 Kujirai, Kawagoe-shi, Saitama
TEL
049-239-1434
Kato-c@toyo.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | KAMADA |
Organization
Toyo University Graduate School
Division name
Graduate School of Information Sciences and Arts
Zip code
350-8585
Address
2100 Kujirai, Kawagoe-shi, Saitama
TEL
080-5483-8838
Homepage URL
yoko8kamada@gmail.com
Sponsor or person
Institute
Toyo University Graduate School of Information Sciences and Arts
Institute
Department
Personal name
Funding Source
Organization
Non
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 Board on Medical Research for Humans 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
東洋大学川越キャンパス(埼玉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2027 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052212
