UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043665 |
|---|---|
| Receipt number | R000049832 |
| Scientific Title | The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications |
| Date of disclosure of the study information | 2021/03/19 |
| Last modified on | 2021/03/19 14:35:02 |
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Basic information
Public title
The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Acronym
The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Scientific Title
The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Scientific Title:Acronym
The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Region
| Japan |
Condition
Condition
nasal obstruction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are as follows:
1) to evaluate the effect of nasal obstruction on sustained exercise and high intensity intermittent exercise.
2) to evaluate of nasal obstruction involved in exercise performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of nasal obstruction on various exercises
Key secondary outcomes
Determining the treatment indication level for nasal obstruction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Normal group / Nasal obstruction group
Interventions/Control_2
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 and Female
Key inclusion criteria
People who habitually exercise moderately
Key exclusion criteria
1) History of hypersensitivity to Naphazoline Nitrate
2) Taking MAO inhibitor
3) History of coronary artery disease, hypertension, hyperthyroidism and diabetes mellitus
4) History of insomnia, dizziness, etc., and due to sympathomimetic drug
5) Pregnant women or women suspected of being pregnant
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | yoshimitsu |
| Middle name | |
| Last name | saito |
Organization
St. Marianna University School of Medicine
Division name
otorhinolaryngology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
y2saitou@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | yoshimitsu |
| Middle name | |
| Last name | saito |
Organization
St. Marianna University School of Medicine
Division name
otorhinolaryngology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
Homepage URL
y2saitou@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
Tel
0449778111
y2saitou@marianna-u.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
| 2021 | Year | 03 | Month | 19 | 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
| 2021 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 03 | Month | 18 | Day |
Last modified on
| 2021 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049832
