UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056162 |
|---|---|
| Receipt number | R000064172 |
| Scientific Title | Analysis of myokine dynamics due to relaxation of the oblique abdominal muscles |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2024/11/15 09:32:58 |
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Basic information
Public title
Analysis of myokine dynamics due to relaxation of the oblique abdominal muscles -Randomised crossover trial-
Acronym
Analysis of myokine dynamics due to relaxation of the oblique abdominal muscles
Scientific Title
Analysis of myokine dynamics due to relaxation of the oblique abdominal muscles
Scientific Title:Acronym
Analysis of myokine dynamics due to relaxation of the oblique abdominal muscles
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the dynamics of myokines due to skeletal muscle relaxation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum myokine concentrations for 15 items
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Perform the 10-minute Kanshoho on the oblique muscles
Interventions/Control_2
Perform the 10-minute pseudo-Kanshoho on the oblique muscles
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1 Men aged 20 to 39 at the time of obtaining consent
2 Individuals with a body mass index (BMI) ranging from 18.5 to 25
Key exclusion criteria
1 Individuals not undergoing therapy for their underlying condition
2 Individuals deemed inappropriate for the research by the supervising physician due to the significant mental and physical load of participation.
3 Individuals deemed unfit by the study's supervisor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hatuka |
| Middle name | |
| Last name | Amitani |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Psychosomatic Internal Medicine
Zip code
890-8520
Address
8-35-1 Sakuragaoka Kagoshima, Japan
TEL
0992755751
amitani@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Amitani |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Psychosomatic Internal Medicine
Zip code
890-8520
Address
8-35-1 Sakuragaoka Kagoshima, Japan
TEL
0992755751
Homepage URL
amitani@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Health Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital
Address
Sakuragaoka 8-35-1, Kagoshima
Tel
099-275-5934
crmc@m2.kufm.kagoshima-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 | 11 | Month | 15 | 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
8
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
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 26 | 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 | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064172
