UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055704 |
|---|---|
| Receipt number | R000063654 |
| Scientific Title | A Crossover Controlled Trial of the Effect of Yoga on Blood Glucose in the Premenstrual Period |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2024/10/02 15:33:45 |
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Basic information
Public title
A Crossover Controlled Trial of the Effect of Yoga on Blood Glucose in the Premenstrual Period
Acronym
A Crossover Controlled Trial of the Effect of Yoga on Blood Glucose in the Premenstrual Period
Scientific Title
A Crossover Controlled Trial of the Effect of Yoga on Blood Glucose in the Premenstrual Period
Scientific Title:Acronym
A Crossover Controlled Trial of the Effect of Yoga on Blood Glucose in the Premenstrual Period
Region
| Japan |
Condition
Condition
Young adults with postprandial glucose spikes and premenstrual syndrome
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of yoga performed on women with premenstrual mental and physical discomfort on post-glucose tolerance blood glucose and mood compared to walking
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incremental Area Under the Curve(iAUC)
Key secondary outcomes
Blood glucose change, cardiac parasympathetic nervous system activity, heart rate, Rate of perceived exertion, Positive and negative affect schedule, Physical activity enjoyment scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
30 minutes of yoga with RPE 11-12
Interventions/Control_2
Walking for 30 minutes with a load of RPE 11-12
Interventions/Control_3
Sitting rest for 30 minutes
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Those who have no exercise habits or premenstrual symptoms
Key exclusion criteria
Have severe cardiac, respiratory, cerebrovascular, or orthopedic disease; have an acute illness or infection; are pregnant or suspected to be pregnant; have an exercise habit; score 12 or less on the abbreviated DRSP; are on a pill of medium dose or higher; have an unstable menstrual cycle; have a blood sugar spike No blood sugar spikes
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Ono |
Organization
Kobe University
Division name
Graduate School of Health Science
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, Japan
TEL
078-792-2555
onoku@tiger.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Ono |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, Japan
TEL
078-792-2555
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences, Health Ethics Audit Committee
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, Japan
Tel
078-796-4502
syomu2@ams.kobe-u.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
| 2024 | Year | 10 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063654
