UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of community on adherence to interval walking training
Title of the study (Brief title)	Habitual exercise training and comminity
Region	Japan

Condition
Condition	life-style related diseases
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of community on the adherence to interval walking training.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The adherence to interval walking training
Key secondary outcomes	1)Excercise intensity, frequency, and duration 2) Physical chracteristics (body weight, body mass index, body fat, blood pressure) 3) Blood composition

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	with communitly(5 months)
Interventions/Control_2	with no community(5 months)
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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those who are more than 40 years old and non-smokers. 2) Those who havwe no difficulaty in paerforming interval walking training with no symptoms of cardiovascular, brain, pualmonary diseases. 3) Those who live in or around Nagano city and wish to participate in the interval walking training program which we propose. 4) Those who agree to participate in the study with document after receiving explanation on the study.
Key exclusion criteria	1) Those who do not pass the criteria above stated. 2) Those who we judged inappropriate to participate in the study for other reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	Shizue Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Address	3-1-1 Asahi Matsumoto 390-8621
TEL	0263-37-2682
Email	masuki@shinshu-u.ac.jp

Public contact
Name of contact person	Hiroshi Nose
Organization	Shinshu University
Division name	Graduate School of Medicine
Address	3-1-1 Asahi Mastumoto 390-8621
TEL	0263-37-2681
Homepage URL
Email	nosehir@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
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)

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	2017 Year 06 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 05 Day
Anticipated trial start date	2017 Year 06 Month 06 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	2017 Year 06 Month 09 Day
Last modified on	2017 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031732