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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034121
Receipt No. R000033251
Scientific Title Development of the vascular rehabilitation method based on the vascular endthelial function mesurement
Date of disclosure of the study information 2018/09/14
Last modified on 2019/09/14

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Basic information
Public title Development of the vascular rehabilitation method based on the vascular endthelial function mesurement
Acronym Development of the vascular rehabilitation method
Scientific Title Development of the vascular rehabilitation method based on the vascular endthelial function mesurement
Scientific Title:Acronym Development of the vascular rehabilitation method
Region
Japan

Condition
Condition patients of life style related diseases or pre-life style related diseases
Classification by specialty
Medicine in general Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aim to investigate the most effective exercise method for the vascular endothelium function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes vascular endothelium function
Key secondary outcomes Various biochemical profiles

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 low intensity exercise of hand grip training
Interventions/Control_2 moderate intensity exercise of hand grip training
Interventions/Control_3 high intensity exercise of hand grip training
Interventions/Control_4 the aerobic exercise level of walking
Interventions/Control_5 sedentary
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects over the age of 20 years with pre and post life style related disease
2. Subjects able to provide written informed consent for study participation
Key exclusion criteria 1. Patients presenting with unstable angina, acute phase acute coronary syndrome
2. Other patients deemed by a physician to be otherwise unsuitable for participation in this study
3. Subjects over the age of 90 years
Target sample size 65

Research contact person
Name of lead principal investigator
1st name Misa
Middle name
Last name Miura
Organization Tsukuba University of Technology
Division name Faculty of health science
Zip code 305-8521
Address 4-12-7 Kasuga, Tsukuba City
TEL 029-858-9552
Email m.miura@k.tsukuba-tech.ac.jp

Public contact
Name of contact person
1st name Misa
Middle name
Last name Miura
Organization Tsukuba University of Technology
Division name Faculty of health science
Zip code 305-8521
Address 4-12-7 Kasuga, Tsukuba City
TEL 029-858-9552
Homepage URL
Email m.miura@k.tsukuba-tech.ac.jp

Sponsor
Institute Tsukuba University of Technology
Institute
Department

Funding Source
Organization Tsukuba University of Technology
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tsukuba University of Technology
Address 4-12-7 Kasuga, Tsukuba City
Tel 029-858-9552
Email m.miura@k.tsukuba-tech.ac.jp

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
2018 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 13 Day
Date of IRB
2017 Year 07 Month 27 Day
Anticipated trial start date
2018 Year 09 Month 13 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 13 Day
Last modified on
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033251

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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