UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042087 |
|---|---|
| Receipt number | R000048024 |
| Scientific Title | Effect of Excretion Posture on Chest Wall Motion |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2022/02/17 10:22:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Excretion Posture on Chest Wall Motion
Acronym
Effect of Excretion Posture on Chest Wall Motion
Scientific Title
Effect of Excretion Posture on Chest Wall Motion
Scientific Title:Acronym
Effect of Excretion Posture on Chest Wall Motion
Region
| Japan |
Condition
Condition
Healthy adults, healthy elderly
Classification by specialty
| Gastroenterology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare chest wall movements of elderly people in a traditional defecation posture with a forward-leaning posture supported by the arm using a handrail to determine whether a supported posture has a positive effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of chest wall motion using a three-dimensional motion analyzer in three postures: Upright, Forward-leaning, Arm-supported forward-leaning
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Take excretory position using upper limb support handrail
Interventions/Control_2
Take excretory position in an uplight sitting position
Interventions/Control_3
Take excretory position in an forward-leaning sitting position
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
| Not applicable |
Gender
Male
Key inclusion criteria
1.Those who have received sufficient explanation about the purpose and contents of this research, have the capacity to consent , voluntarily volunteer with full understanding, and agree to participate in the document
2.Healthy adults over the age of 20 years and under the age of 65
3.Healthy elderly people over 65 years old
Key exclusion criteria
Those who did not agree with this research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tashiro |
Organization
Kobegakuin University
Division name
Department of Occupational Therapy, Faculty of Rehabilitation
Zip code
651-2180
Address
518 Arise Ikawadanichou, Nishiku, Kobe City, Hyogo
TEL
078-974-1551
tashiro@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Tashiro |
Organization
Kobegakuin University
Division name
Department of Occupational Therapy, Faculty of Rehabilitation
Zip code
651-2180
Address
518 Arise Ikawadanichou, Nishiku, Kobe City, Hyogo
TEL
078-974-1551
Homepage URL
tashiro@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobegakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobegakuin 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
Department of Occupational Therapy, Faculty of Rehabilitation, Kobegakuin University
Address
518 Arise Ikawadanichou, Nishiku, Kobe City, Hyogo
Tel
078-974-1551
tashiro@reha.kobegakuin.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
| 2020 | Year | 12 | 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
20
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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048024
