UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045860 |
|---|---|
| Receipt number | R000051292 |
| Scientific Title | A study of pulmonary and systematic oxidative stress caused by exercise in heat-not-burn cigarette users |
| Date of disclosure of the study information | 2021/10/25 |
| Last modified on | 2024/02/18 22:14:33 |
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Basic information
Public title
A study of pulmonary and systematic oxidative stress caused by exercise in heat-not-burn cigarette users
Acronym
A study of pulmonary and systematic oxidative stress caused by exercise in heat-not-burn cigarette users
Scientific Title
A study of pulmonary and systematic oxidative stress caused by exercise in heat-not-burn cigarette users
Scientific Title:Acronym
A study of pulmonary and systematic oxidative stress caused by exercise in heat-not-burn cigarette users
Region
| Japan |
Condition
Condition
smoker
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects on oxidative stress after exercise in heat-not-burn cigarette smokers, and to compare the effects with conventional cigarette smokers and nonsmokers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of H2O2 in exhaled breath condensate(EBC) and plasma
Key secondary outcomes
Height, Weight, Exercise custom, Smoking custom, History of past illness, present illness, Medication status, Electrocardiogram, Modified Borg scale after exercise, Maximum output power of ergometer
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Wingate anaerobic test in heat-not-burn cigarette users.
Interventions/Control_2
Wingate anaerobic test in conventional cigarette users.
Interventions/Control_3
Wingate anaerobic test in nonsmokers.
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Smokers using heat-not-burn cigarettes/conventional cigarettes every day or nonsmokers.
2) Heat-not-burn cigarette or conventional cigarette smokers who can stop smoking for 12 hours.
3) Those whose smoking of heat-not-burn cigarettes accounts for 90% or more of their smoking occasions in a month.
4) Heat-not-burn cigarette smokers who changed from conventional cigarette over 1 year ago.
5) Conventional cigarette smokers who has smoking over 1 year.
6) Participants that it was obtained the written person's consent.
Key exclusion criteria
1) Those who are willing to quit smoking as of the date of study entry.
2) Those who have diseases that are aggravated by smoking, such as macrovascular disease and microvascular disease.
3)Those who have no diseases such as metabolic diseases, inflammatory diseases, pneumonic diseases, and orthopedic limitations.
4) Those who have taking an antioxidant compound (including vitamin) or an anti-inflammatory medication.
5) Students for whom the principal investigator is teaching a leture.
6) Those who were judged to be inappropriate by principal researcher.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Hamada |
Organization
Hiroshima University
Division name
Department of Physical Analysis and Therapeutic Sciences
Zip code
734-8553
Address
1-2-3-, Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-257-5420
hirohamada@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Takagi |
Organization
Hiroshima University
Division name
Department of Physical Analysis and Therapeutic Sciences
Zip code
734-8553
Address
1-2-3-, Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-257-5422
Homepage URL
atakagi-dragons@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Hiroshima University Certified Review Board
Address
1-2-3-, Kasumi, Minami-ku, Hiroshima, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-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 | 10 | 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
30
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 18 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051292
