UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055122 |
|---|---|
| Receipt number | R000062971 |
| Scientific Title | The effect of stretching on the electroencephalography of people with irritable bowel syndrome |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/07/28 10:25:58 |
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Basic information
Public title
The effect of stretching on the electroencephalography of people with irritable bowel syndrome
Acronym
The effect of stretching on the electroencephalography of people with irritable bowel syndrome
Scientific Title
The effect of stretching on the electroencephalography of people with irritable bowel syndrome
Scientific Title:Acronym
The effect of stretching on the electroencephalography of people with irritable bowel syndrome
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of stretching on the electroencephalography of people with IBS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electroencephalogram
Key secondary outcomes
Rome4 criteria
IBS-severity (IBS-SI)
IBS-QOL
sensory threshold, pain threshold
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
IBS symptom group
Stretch for 4 minutes.
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Male
Key inclusion criteria
Japanese
Male
18 years old and under 39 years old
Key exclusion criteria
People receiving IBS treatment
People with mental illnesses
People with lower back or back pain
People attending an orthopedic clinic
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Tayama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama,359-1192, Japan
TEL
+81-4-2947-6849
tyasukawa@fuji.waseda.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Yasukawa |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama,359-1192, Japan
TEL
+81-4-2947-6849
Homepage URL
tyasukawa@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University Ethical Review Committee concerning Research with Human Subjects
Address
1-104, Totsuka, Shinjuku, Tokyo, 169-8050, Japan
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
| 2024 | Year | 08 | 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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062971
