UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052137 |
|---|---|
| Receipt number | R000059507 |
| Scientific Title | The effect of dynamic stretching on blood glucose levels in young adult women wearing a pregnancy experience jacket |
| Date of disclosure of the study information | 2023/09/07 |
| Last modified on | 2024/12/19 09:18:56 |
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Basic information
Public title
The effect of dynamic stretching on blood glucose levels in young adult women wearing a pregnancy experience jacket
Acronym
The effect of dynamic stretching on blood glucose levels in young adult women wearing a pregnancy experience jacket
Scientific Title
The effect of dynamic stretching on blood glucose levels in young adult women wearing a pregnancy experience jacket
Scientific Title:Acronym
The effect of dynamic stretching on blood glucose levels in young adult women wearing a pregnancy experience jacket
Region
| Japan |
Condition
Condition
Young adults with postprandial glucose spikes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in blood glucose levels with dynamic stretching after glucose loading
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood Glucose Level, Postprandial blood glucose peak, Postprandial blood glucose spike, incremental area under the curve for postprandial increases in blood glucose concentration
Key secondary outcomes
Heart rate, rate of perceived exertion, joint range of motion, Visual Analog scale (VAS) for degree of back pain, cardiac parasympathetic nervous system activity
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
4
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Rest (Sitting) < glucose tolerance test < dynamic stretching (lying or sitting) (Bst condition) < recovery (sitting)
Interventions/Control_2
Rest (Sitting) < glucose tolerance test < dynamic stretching (standing) (Sst condition) < recovery (sitting)
Interventions/Control_3
Rest (Sitting) < glucose tolerance test < Treadmill walking with comfort speed (W condition) < recovery (sitting)
Interventions/Control_4
Rest (Sitting) < glucose tolerance test < Rest (sitting) (C condition) < recovery (sitting)
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
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Female university students with postprandial blood glucose spikes who have given written informed consent
Key exclusion criteria
Males, those with documented impaired glucose intolerance, those with a history of cardiovascular disease, those with abnormal electrocardiograms, those taking medium- or high-dose pills, those with menstrual irregularities, and those who have difficulty exercising due to premenstrual symptoms
Target sample size
10
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 Sciences
Zip code
6540142
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 Scienses
Zip code
6540142
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
Institute
Department
Personal name
Funding Source
Organization
None
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
Kobe university Graduate School of Health Sciences, Health Science ethical review board
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
| 2023 | Year | 09 | Month | 07 | 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
9
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
Main results already published
Date of protocol fixation
| 2022 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059507
