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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043665
Receipt No. 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

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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
Email 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
Email y2saitou@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049832

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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