UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004481 |
|---|---|
| Receipt number | 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 22:30:38 |
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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
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
myamaoka@med.kitasato-u.ac.jp
Sponsor or person
Institute
Cardiovascular Medicine, Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005361
