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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042087
Receipt No. R000048024
Scientific Title Effect of Excretion Posture on Chest Wall Motion
Date of disclosure of the study information 2020/12/01
Last modified on 2020/10/12

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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
Email 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
Email tashiro@reha.kobegakuin.ac.jp

Sponsor
Institute Kobegakuin University
Institute
Department

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
Email 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
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
2020 Year 12 Month 01 Day
Date of IRB
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
2020 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048024

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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