UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Atheroprotective effects of lifestyle modification (rehabilitation for internal disorders) and biomarkers to predict the efficacy
Title of the study (Brief title)	lifestylemodification and its biomarkers
Region	Japan

Condition
Condition	high-risk patients for cardiovascular disease
Classification by specialty	Medicine in general Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine useful biomarkers to predict the efficacy for effective lifestyle modification
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes from baseline in vascular endothelial function
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	education for ifestyle modification a. reduced solt (< 6 g/day) b. adequate energy intake (1) prohibit eating snacks and sweets (2) prohibit eating dinner late at night (3) prohibit over intake of alcohol (4) prohibit over intake of carbohydrate (5) prohibit over intake of fat c. stop smoking d. exercise (1) aerobic exercise 30 min/day, 5 days aweek (2)registance training (3)increasing physical activities
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	High-risk patients for cardiovascular disease in Kitasato University Hospital and Kitasato University East hospital who have more than one coronary risk factor and need to have rehabilitation ofinternal dysorders and medical educational training (e.g. hypertenison, dyslipidemia, fasting high glucose/diabetes mellitus, obesity, current smoker)
Key exclusion criteria	having difficulty with the walking due to of leg dysability or central nervous system diseases severe heart failure (BNP > 200 pg/mL)
Target sample size	200

Research contact person
Name of lead principal investigator	Minako Yamaoka-Tojo
Organization	Kitasato University School of Allied Health Scineces
Division name	PT
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Japan
TEL	042-778-8111
Email	myamaoka@med.kitasato-u.ac.jp

Public contact
Name of contact person	Minako Yamaoka-Tojo
Organization	Kitasato University East Hospital
Division name	the Kitasato Registry for Cardiovascular Disease Preventionl
Address	Sagamihara
TEL	042-778-8111
Homepage URL
Email	myamaoka@med.kitasato-u.ac.jp

Sponsor
Institute	Cardiovascular Medicine, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Cardiovascular Medicine, Kitasato University School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2010 Year 10 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 28 Day
Anticipated trial start date	2010 Year 07 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 10 Month 30 Day
Last modified on	2018 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005361