UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012781 |
|---|---|
| Receipt number | R000014924 |
| Scientific Title | The effects of dual-task exercise training on cognitive function and plasma amyloid be-ta protein 42 level in the healthy elderly |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/08/13 09:54:22 |
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Basic information
Public title
The effects of dual-task exercise training on cognitive function and plasma amyloid be-ta protein 42 level in the healthy elderly
Acronym
The effects of dual-task exercise training on cognitive function and plasma amyloid be-ta protein 42 level in the healthy elderly
Scientific Title
The effects of dual-task exercise training on cognitive function and plasma amyloid be-ta protein 42 level in the healthy elderly
Scientific Title:Acronym
The effects of dual-task exercise training on cognitive function and plasma amyloid be-ta protein 42 level in the healthy elderly
Region
| Japan |
Condition
Condition
The healthy elderly
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of dual-task exercise training on the cognitive function and plasma amyloid be-ta protein 42 level in the healthy elderly without marked dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive function assessed by the modified mini-mental state examination (3MS) and trail making test
plasma amyloid be-ta protein 42 level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
dual-task exercise training comprising 3 times of 1-h session a week with 3-month follow up period.
Interventions/Control_2
single-task exercise training comprising 3 times of 1-h session a week with 3-month follow up period.
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
| 65 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The healthy sedentary elderly
Key exclusion criteria
The subjects with arrhythmia, history of ischemic heart disease, chronic heart failure, hypertension (with systolic BP more than 160 mmHg or diastolic BP more than 100 mmHg), and chronic disease such as diabetes, renal dysfunction or neuropsychiatric disorder.
The subjects judged to be inappropriate for enrolled to exercise program.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisayo Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
06-6605-2947
yokoyama@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisayo Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
06-6605-2947
Homepage URL
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
TIPNESS Inc.
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
| 2014 | Year | 04 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
| 2014 | Year | 01 | Month | 07 | Day |
Last modified on
| 2015 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014924
| 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 |
