UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037159 |
|---|---|
| Receipt number | R000042337 |
| Scientific Title | Behavioral, Cognitive Alteration and Brain structure changes through yoga practicing. |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/07/02 18:06:02 |
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Basic information
Public title
Behavioral, Cognitive Alteration and Brain structure changes through yoga practicing.
Acronym
Behavioral, Cognitive Alteration and Brain structure changes through yoga practicing.
Scientific Title
Behavioral, Cognitive Alteration and Brain structure changes through yoga practicing.
Scientific Title:Acronym
Behavioral, Cognitive Alteration and Brain structure changes through yoga practicing.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether hatha yoga practice can improve mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference between Pre / Post condition before and 12 weeks after the start of the exam
MRI brain image (brain structure structure, DTI, resting state fMRI)
Physiological index (breathing, heartbeat)
Questionnaire (Gratitude scale, State self-esteem scale, self-compaction scale)
During the study period (once every 4 weeks)
Questionnaire(Rosenberg self-esteem scale, multidimensional assessment of Interoceptive Awareness)
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
12 weeks hatha yoga practice
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
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People who have not continuous hatha yoga practice.
Key exclusion criteria
People who have had continuous hatha yoga practice.
People who fall under exclusion criteria of MRI
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Rieko |
| Middle name | |
| Last name | Osu |
Organization
Waseda University
Division name
Faculty of Human Science
Zip code
359-1192
Address
135-1 Horinouchi, Tokorozawa, Saitama
TEL
04-2947-7346
r.osu@waseda.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tsuno |
Organization
Waseda University
Division name
School of Human Science
Zip code
359-1192
Address
135-1 Horinouchi, Tokorozawa, Saitama
TEL
04-2947-7346
Homepage URL
tsunochie@ruri.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University
Address
1-104, Totsuka-Cho, Shinjuku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2019 | Year | 07 | Month | 01 | 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
| 2019 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | 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
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042337
