UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the impact of exercise on non smoking continuation
Title of the study (Brief title)	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	Koji Hasegawa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Clinical Research Institute
Address	1-1 Mukaihata-cho, Fukakusa Fushimi-ku, Kyoto 612-8555 Japan
TEL	075-641-9161
Email	koj@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yuka Ozaki
Organization	National Hospital Organization Kyoto Medical Center
Division name	Clinical Research Institute
Address	Mukaihata-cho, Fukakusa Fushimi-ku, Kyoto 612-8555 Japan
TEL	075--641-9161
Homepage URL
Email	timutimu0712@gmail.com

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017007