UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057314 |
|---|---|
| Receipt number | R000065519 |
| Scientific Title | The effects of respiratory muscle training and its cessation on the swimming performance and respiratory function of junior swimmers |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/03/17 17:33:22 |
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Basic information
Public title
The effects of respiratory muscle training and its cessation on the swimming performance and respiratory function of junior swimmers
Acronym
The effects of respiratory muscle training and its cessation on the swimming performance and respiratory function of junior swimmers
Scientific Title
The effects of respiratory muscle training and its cessation on the swimming performance and respiratory function of junior swimmers
Scientific Title:Acronym
The effects of respiratory muscle training and its cessation on the swimming performance and respiratory function of junior swimmers
Region
| Japan |
Condition
Condition
Healthy junior swimmers (ages 12-18)
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the effects of a two-week intervention of respiratory muscle training for junior swimmers and the cessation of this intervention (for two weeks) on respiratory function and swimming performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
100m freestyle swimming time, inspiratory and expiratory muscle strength, vital capacity, forced vital capacity, forced expiratory volume 1-sec (L, %)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
2 sets of 30-50 inhalations and exhalations at 50-70% of maximum inspiratory and expiratory muscle strength, once a day for 10 days (10 times in total)
Interventions/Control_2
Not doing respiratory muscle training
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No respiratory or skin diseases, and no daily medication
Key exclusion criteria
Those with respiratory or skin diseases, or those taking daily medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
fujimoto@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
Homepage URL
fujimoto@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
Tel
0252574675
fujimoto@nuhw.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
| 2025 | Year | 03 | Month | 17 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065519
