UMIN-CTR Clinical Trial

Basic information
Public title	Effect of maximal abdominal bulging on respiratory function
Acronym	Effect of maximal abdominal bulging on respiratory function
Scientific Title	Effect of maximal abdominal bulging on respiratory function
Scientific Title:Acronym	Effect of maximal abdominal bulging on respiratory function
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Pneumology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify the effect of the "maximum abdominal ridge method", which exercises with maximum awareness of the amount of abdominal swelling as inspiratory muscle training.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal bulge
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Repeat maximum abdominal ridge movement
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	20 years-old <=
Age-upper limit	29 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing. 2. Healthy adults aged 20 to 29
Key exclusion criteria	Those who did not agree with this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Tashiro
Organization	Kobe Gakuin University
Division name	Faculty of Rehabilitation, Department of Occupational Therapy
Zip code	651-2180
Address	518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi, 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	Kobe Gakuin University
Division name	Faculty of Rehabilitation, Department of Occupational Therapy
Zip code	651-2180
Address	518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi, Hyogo
TEL	078-974-1551
Homepage URL
Email	tashiro@reha.kobegakuin.ac.jp

Sponsor
Institute	Kobe Gakuin University
Institute
Department

Funding Source
Organization	Kobe Gakuin 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, Kobe Gakuin University
Address	518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi, 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	2021 Year 08 Month 20 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	2021 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 07 Day
Last follow-up date	2021 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 18 Day
Last modified on	2021 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051624