UMIN-CTR Clinical Trial

Basic information
Public title	Identification of the effective respiratory muscle training in healthy subjects
Acronym	Identification of the respiratory muscle training
Scientific Title	Identification of the effective respiratory muscle training in healthy subjects
Scientific Title:Acronym	Identification of the respiratory muscle training
Region	Japan

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

Objectives
Narrative objectives1	The obejective of this study is to perform 3 types of respiratory muslce training and identify the most effective method for strengthening respiratory muscle power and mass, and cough.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of respiratory muscle strength after 4 weeks of training
Key secondary outcomes	Evaluation of respiratory muscle mass and cough strength after 4 weeks of training

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	An inspiratory muscle training device, 3 times a week for 4 weeks.
Interventions/Control_2	An expiratory muscle training device, 3 times a week for 4 weeks.
Interventions/Control_3	Abdominal muscle training 2 times a week for 4 weeks
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Community dwelling general adults
Key exclusion criteria	People with upper airway infection People with past hisoty of pneumothorax
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Shin-Ichi Middle name Last name Izumi
Organization	Tohoku University Graduate School of Medicine
Division name	Physical Medicine and Rehabilitation
Zip code	980-8575
Address	2-1 Seiryocho, Aoba-ku, Sendai, Miyagi, JAPAN
TEL	022-717-7338
Email	izumis@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Tatsuma Middle name Last name Okazaki
Organization	Tohoku University Hospital
Division name	Physicla Medicine and Rehabilitation Department
Zip code	980-8575
Address	2-1 Seiryocho, Aoba-ku, Sendai, Miyagi, JAPAN
TEL	022-717-7338
Homepage URL
Email	tmokazaki0808@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2022 Year 01 Month 25 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	Open public recruiting
Date of protocol fixation	2022 Year 01 Month 05 Day
Date of IRB	2022 Year 01 Month 24 Day
Anticipated trial start date	2022 Year 01 Month 26 Day
Last follow-up date	2026 Year 12 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	2022 Year 01 Month 25 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053308