UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012781
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yokoyama@sports.osaka-cu.ac.jp

Sponsor
Institute Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) 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
Registered date File name

Research case data
Registered date File name


Contact us.