UMIN-CTR Clinical Trial

Basic information
Public title	Effects of respiratory muscle stretch gymnastics in term of respratory function, chest wall expansion, and respiratory muscle strength in healthy subjects.
Acronym	Effects of respiratory muscle stretch gymnastics in healthy subjects.
Scientific Title	Effects of respiratory muscle stretch gymnastics in term of respratory function, chest wall expansion, and respiratory muscle strength in healthy subjects.
Scientific Title:Acronym	Effects of respiratory muscle stretch gymnastics in term of respratory function, chest wall expansion, and respiratory muscle strength in healthy subjects.
Region	Japan

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

Objectives
Narrative objectives1	To clarify changes in respiratory function, chest wall expansion, and respiratory muscle strength before and after respiratory muscle stretch gymnastics in healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	respiratory muscle strength
Key secondary outcomes	pulmonary function, chest wall expansion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	respiratory muscle stretch gymnastics (6 exercises, 4 times)
Interventions/Control_2	take a rest for the same amount of time as performing respiratory muscle stretch gymnastics
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	Not applicable
Gender	Male
Key inclusion criteria	healthy adults male aged ages 20 and over
Key exclusion criteria	those with respiratory disease those who had a history of respiratory disease within one month those with painful orthopedic diseases that can affecing respiratory muscle stretching gymnastics
Target sample size	50

Research contact person
Name of lead principal investigator	1st name AKIRA Middle name Last name MORINO
Organization	Hokkaido Chitose College of Rehabilitation
Division name	Department of Rehabilitation
Zip code	066-0055
Address	Satomi 2-10, Chitose, Hokkaido
TEL	0123-28-5331
Email	a-morino@chitose-reha.ac.jp

Public contact
Name of contact person	1st name AKIRA Middle name Last name MORINO
Organization	Hokkaido Chitose College of Rehabilitation
Division name	Department of Rehabilitation
Zip code	066-0055
Address	Satomi 2-10, Chitose, Hokkaido
TEL	0123-28-5331
Homepage URL
Email	a-morino@chitose-reha.ac.jp

Sponsor
Institute	Hokkaido Chitose College of Rehabilitation
Institute
Department

Funding Source
Organization	Hokkaido Chitose College of Rehabilitation
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	Hokkaido chitose college of rehabilitation ethics committee
Address	Satomi 2-10, Chitose, Hokkaido
Tel	0123285331
Email	rinrishinsa@chitose-reha.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 01 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	50
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	2019 Year 11 Month 22 Day
Date of IRB	2019 Year 12 Month 04 Day
Anticipated trial start date	2020 Year 01 Month 27 Day
Last follow-up date	2020 Year 10 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	2020 Year 01 Month 26 Day
Last modified on	2021 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044772