UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046724 |
|---|---|
| Receipt number | R000053308 |
| Scientific Title | Identification of the effective respiratory muscle training in healthy subjects |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2022/07/27 17:33:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tmokazaki0808@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053308
