UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014615 |
|---|---|
| Receipt number | R000017007 |
| Scientific Title | A study on the impact of exercise on non smoking continuation |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2019/01/07 22:50:02 |
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Basic information
Public title
A study on the impact of exercise on non smoking continuation
Acronym
SIENS
Scientific Title
A study on the impact of exercise on non smoking continuation
Scientific Title:Acronym
SIENS
Region
| Japan |
Condition
Condition
Smoking(former smokers who quit smoking for at least a month in smoking cessation program)
Classification by specialty
| Cardiology | Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the effect of exercise on continuation of smoking cessation after treatment at smoking cessation clinic
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(success) rate of continuous smoking cessation
Key secondary outcomes
Change of the metabolism index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Duration one year(after treatment at smoking cessation clinic)
Interventions/Control_2
exercise
3times
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
former smokers who quit smoking for at least a month in three-month smoking cessation program
1,subjects who don't have exercise habit
2, subject who agree to participate in the study with a written informed consent
*) exercise habit is defined as doing 30 minutes exercise more than twice a week
Key exclusion criteria
1,The person who is forbidden exercise by a doctor
2,The person who has difficulty in exercise by an orthopedics disease, a neuromuscular disease, peripheral vascular disease
3,Pregnant woman
4,Hospitalization or facilities entrance person
5,Subject who are evaluated to be ineligible by a physician for other reasons
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
Address
1-1 Mukaihata-cho, Fukakusa Fushimi-ku, Kyoto 612-8555 Japan
TEL
075-641-9161
koj@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Ozaki |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
Address
Mukaihata-cho, Fukakusa Fushimi-ku, Kyoto 612-8555 Japan
TEL
075--641-9161
Homepage URL
timutimu0712@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation,The Japanese Society of Cardiovascular Disease Prevention,AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部付属病院(京都府）Kyoto University Hospital
国立病院機構京都医療センター（京都府）National Hospital Organization Kyoto Medical Center
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | 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
| 2014 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 22 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
