UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053985 |
|---|---|
| Receipt number | R000061621 |
| Scientific Title | Investigating the Immediate Effects of Respiratory Muscle Stretching Exercises (Self-Stretching) in College Athletes: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/03/28 |
| Last modified on | 2024/03/27 17:35:01 |
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Basic information
Public title
Investigating the Immediate Effects of Respiratory Muscle Stretching Exercises (Self-Stretching) in College Athletes: A Randomized Controlled Trial
Acronym
Investigating the Immediate Effects of Respiratory Muscle Stretching Exercises (Self-Stretching) in College Athletes: A Randomized Controlled Trial
Scientific Title
Investigating the Immediate Effects of Respiratory Muscle Stretching Exercises (Self-Stretching) in College Athletes: A Randomized Controlled Trial
Scientific Title:Acronym
Investigating the Immediate Effects of Respiratory Muscle Stretching Exercises (Self-Stretching) in College Athletes: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Healthy college athlete
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the immediate effects of respiratory muscle stretching exercises and regular stretching exercise interventions on student athletes through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in respiratory muscle strength (maximal inspiratory and expiratory intraoral pressure) before and after intervention (after 15 minutes)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention group consists of respiratory muscle stretching exercises (5 different stretching exercises, each performed for 10 seconds, 3 times).
Interventions/Control_2
The control group will perform the same stretching exercises with dynamic stretching (10 times twice the exercises. ).
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1 Age between 20 and 65 years old at the time of obtaining consent.
2 Those who, after receiving a full explanation of their participation in this study, have obtained written consent of their own free will based on a thorough understanding of the subject's situation.
Key exclusion criteria
1 Have a history of underlying disease (especially respiratory, cardiovascular, neurological, or orthopedic disease).
2 Other persons deemed inappropriate as research subjects by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Respiratory Medicine
Zip code
1360075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
kmatsuno@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Department of Respiratory Medicine
Division name
Department of Respiratory Medicine
Zip code
1360075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo
TEL
0356323111
Homepage URL
kmatsuno@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
Juntendo University School of Medicine Ethics Committee for Medical Research
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
kmatsuno@juntendo.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
| 2024 | Year | 03 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
