UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057806 |
|---|---|
| Receipt number | R000066068 |
| Scientific Title | A prospective interventional study on the effects of Yoga on metabolic dysfunction-associated steatotic liver disease |
| Date of disclosure of the study information | 2025/05/10 |
| Last modified on | 2025/05/09 20:13:04 |
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Basic information
Public title
A prospective interventional study on the effects of Yoga on metabolic dysfunction-associated steatotic liver disease
Acronym
A prospective interventional study on the effects of Yoga on metabolic dysfunction-associated steatotic liver disease
Scientific Title
A prospective interventional study on the effects of Yoga on metabolic dysfunction-associated steatotic liver disease
Scientific Title:Acronym
A prospective interventional study on the effects of Yoga on metabolic dysfunction-associated steatotic liver disease
Region
| Japan |
Condition
Condition
Metabolic dysfunction associated steatotic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although exercise therapy is recommended for metabolic dysfunction associated steatotic liver disease (MASLD), there are numerous reports on what types of exercise are appropriate, and a standardized method has yet to be established. There is a need to identify an effective form of exercise that can be easily performed and sustainably continued at home to improve fatty liver disease.This study aims to clarify the effects of yoga,a mind-body training method that originated in ancient India with an emphasis on breathing and has since developed into a widely practiced form of relaxation exercise,on patients with MASLD. Specifically, we will evaluate its impact on blood test parameters, abdominal ultrasound findings, body composition, mental health, and quality of life, including symptoms commonly associated with liver disease such as muscle cramps.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver function data (e.g. AST, ALT, G-GTP) and metabolic function data (e.g. TG, T-chol, LDL-chol, HbA1c) at 12 weeks after starting yoga.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will be required to complete a 12-week yoga program consisting of at least three 45-minute yoga sessions per week. This includes a monthly in-person yoga workshop and a weekly online session. Outside of the scheduled workshops, participants will perform yoga independently. At the start of the yoga intervention, participants will be provided with a video containing the same program as the workshops. They will perform the yoga exercises individually while referring to the video.
Interventions/Control_2
The control group will receive only standard lifestyle guidance from their attending physician during outpatient visits and will independently engage in lifestyle modifications over a 12-week period.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with MASLD at the Department of Gastroenterology, Tohoku University Hospital, and receiving follow-up care with lifestyle guidance in an outpatient setting.
(2) Individuals aged 18 years or older, but under 75 years.
(3) No restriction on gender.
(4) Liver biopsy status is not a criterion.
(5) Patients classified as Child-Pugh Class A or B.
Key exclusion criteria
(1) Patients undergoing treatment for cardiovascular or respiratory diseases, with impaired cardiopulmonary function.
(2) Patients undergoing treatment for muscular or neurological disorders, or those experiencing organic or functional limitations in movement.
(3) Elderly individuals aged 75 and above.
(4) Patients with cognitive dysfunction or psychiatric disorders.
(5) Patients who are pregnant or within 28 days postpartum.
(6) Patients classified as Child-Pugh Class C.
(7) Patients with a pre-existing habit of physical activity such as yoga.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Inoue |
Organization
Tohoku University
Division name
Institute for excellence in higher education
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi, Japan
TEL
022-717-7171
jun.inoue.d8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mio |
| Middle name | |
| Last name | Tsuruoka |
Organization
Tohoku University Hospital
Division name
Department of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi, 980-8574, Japan
TEL
022-717-7171
Homepage URL
ytrsb237@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066068
