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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004481
Receipt No. R000005361
Scientific Title Atheroprotective effects of lifestyle modification (rehabilitation for internal disorders) and biomarkers to predict the efficacy
Date of disclosure of the study information 2010/10/30
Last modified on 2018/05/05

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Basic information
Public title Atheroprotective effects of lifestyle modification (rehabilitation for internal disorders) and biomarkers to predict the efficacy
Acronym lifestylemodification and its biomarkers
Scientific Title Atheroprotective effects of lifestyle modification (rehabilitation for internal disorders) and biomarkers to predict the efficacy
Scientific Title:Acronym 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
1st name
Middle name
Last name Minako Yamaoka-Tojo
Organization Kitasato University School of Allied Health Scineces
Division name PT
Zip code
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
1st name
Middle name
Last name Minako Yamaoka-Tojo
Organization Kitasato University East Hospital
Division name the Kitasato Registry for Cardiovascular Disease Preventionl
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 06 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000005361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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