UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054684 |
|---|---|
| Receipt number | R000062490 |
| Scientific Title | Effects of posture on intestinal peristalsis and autonomic nervous activity in healthy young adults |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/06/17 17:45:13 |
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Basic information
Public title
Effects of posture on intestinal peristalsis and autonomic nervous activity in healthy young adults
Acronym
Effects of posture on intestinal peristalsis and autonomic nervous activity
Scientific Title
Effects of posture on intestinal peristalsis and autonomic nervous activity in healthy young adults
Scientific Title:Acronym
Effects of posture on intestinal peristalsis
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of changes in posture and movement on intestinal peristalsis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel Sound
Key secondary outcomes
Electrocardiogram, Blood Pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
supine
Interventions/Control_2
standing
Interventions/Control_3
sitting
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy young adult male
Key exclusion criteria
Female, undergoing treatment for abdominal disease, previous abdominal recovery surgery, pain disorder, previous abnormal ECG
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Oka |
Organization
Reiwa Health Sciences University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
8110213
Address
2-1-12, Wajirogaoka, Higashi-ku, Fukuoka City, Fukuoka
TEL
092-607-6701
s.oka@kyoju.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Oka |
Organization
Reiwa Health Sciences University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
8110213
Address
2-1-12, Wajirogaoka, Higashi-ku, Fukuoka City, Fukuoka
TEL
092-607-6701
Homepage URL
s.oka@kyoju.ac.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Reiwa Health Sciences University
Address
2-1-12, Wajirogaoka, Higashi-ku, Fukuoka City, Fukuoka
Tel
092-607-6701
s.oka@kyoju.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 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | 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 | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062490
