UMIN-CTR Clinical Trial

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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