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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029923
Receipt No. R000034184
Scientific Title A study to find the most effective treatment strategy to suppress dementia progression in cardiovascular disease associated diabetic patients
Date of disclosure of the study information 2019/01/01
Last modified on 2017/11/10

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Basic information
Public title A study to find the most effective treatment strategy to suppress dementia progression in cardiovascular disease associated diabetic patients
Acronym A study to find the most effective treatment strategy to suppress dementia progression in cardiovascular disease associated diabetic patients
Scientific Title A study to find the most effective treatment strategy to suppress dementia progression in cardiovascular disease associated diabetic patients
Scientific Title:Acronym A study to find the most effective treatment strategy to suppress dementia progression in cardiovascular disease associated diabetic patients
Region
Japan

Condition
Condition Cardiovascular disease, dementia
Classification by specialty
Cardiology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Develop new cardiac rehabilitation programs which is useful for improvement of congnitive function in patients with diabetes mellitus and heart disease, and verify its effect in acute and chronic phase.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Calculation of hippocampal volume by MRI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Whole-body vibration stimulation therapy
Interventions/Control_2 Conventional cardiac rehabilitation
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
70 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Cardiovascular disease patients who registered Kitasato University East Hospital,associated diabetic and be over 70 years old.
Key exclusion criteria Patients who can't be inspect by MRI.
Patients who have undertaken rehabilitation.
Patients who diagnosed dementia.
Patients who experience Whole-body vibration stimulation therapy
Patients who diagnosed severe orthopedic disease
Patients who diagnosed CKD
Patients who diagnosed ASO
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimitsu Sato
Organization Kitasato University Graduate School
Division name Medical sciences
Zip code
Address 1-15-1 kitasato minami sagamihara kanagawa
TEL 042-778-8111
Email toshimitsu_kitasato@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimitsu Sato
Organization Kitasato University Graduate School
Division name Medical sciences
Zip code
Address 1-15-1 kitasato minami sagamihara kanagawa
TEL 042-778-8111
Homepage URL
Email toshimitsu_kitasato@yahoo.co.jp

Sponsor
Institute Kitasato University Graduate School
Institute
Department

Funding Source
Organization Kitasato University Graduate School
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
2019 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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
2017 Year 11 Month 10 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034184

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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