UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029923 |
|---|---|
| Receipt number | 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 | 2023/05/16 16:59:48 |
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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 | Toshimitsu |
| Middle name | |
| Last name | Sato |
Organization
Kitasato University Graduate School
Division name
Medical sciences
Zip code
252-0375
Address
1-15-1 kitasato minami sagamihara kanagawa
TEL
042-778-8111
toshimitsu_kitasato@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Sato |
Organization
Kitasato University Graduate School
Division name
Medical sciences
Zip code
252-0375
Address
1-15-1 kitasato minami sagamihara kanagawa
TEL
042-778-8111
Homepage URL
toshimitsu_kitasato@yahoo.co.jp
Sponsor or person
Institute
Kitasato University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
non
Name of secondary funder(s)
non
IRB Contact (For public release)
Organization
Kitasato University Graduate School
Address
1-15-1, Kitazato, Minami, Sagamihara, Kanagawa
Tel
042-778-8111
non
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
non
Publication of results
Unpublished
Result
URL related to results and publications
non
Number of participants that the trial has enrolled
0
Results
Cancel
Results date posted
| 2022 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cancel
Participant flow
Cancel
Adverse events
non
Outcome measures
Cancel
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 01 | Day |
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
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034184
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
