UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045745
Receipt No. 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 2021/10/15

* 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
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
Email 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
Email yoko8kamada@gmail.com

Sponsor
Institute Toyo University Graduate School of Information Sciences and Arts
Institute
Department

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
Email 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 Open public 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
2023 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
2021 Year 10 Month 13 Day
Last modified on
2021 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052212

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.