UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018933
Receipt No. R000021903
Scientific Title Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia
Date of disclosure of the study information 2016/01/20
Last modified on 2016/01/20

* 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 Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia
Acronym Exercise and cognition
Scientific Title Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia
Scientific Title:Acronym Exercise and cognition
Region
Asia(except Japan)

Condition
Condition On going study
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Purpose of this study was to examined the Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Combined exercise improve to cognitive function in patients with mild cognitive impairment
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 3 time/week for 12 weeks combined exercise/
Interventions/Control_2 control group - free-living activity
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
50 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients and caregivers should appeal to a loss of memory.
2. No significant activity of daily activity
3. dementia should not be at the discretion of the clinician.
4. Patients who can read and write text
5. Age 50-85 years old
6. Regular (Note 3 times ) no exercise habits.
7. Patients participating in the study must agree in writing.
Key exclusion criteria 1. Rated for clinical trials about treatment, participate in another clinical trial within the last 4 weeks.
2. Unstable physical evidence of the disease
3. In the past year received a diagnosis of major depression.
4. Patients with a finding that could lead to effects on cognitive function in clinical pathology
5. within the last 10 years drug addiction or alcoholism in patients with a history.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kwon Won Park
Organization Dong-A University
Division name College of Medicine
Zip code
Address 32, Daeshingongwon-Ro, Seo-Gu, Busan, 602-715 Rep. of Korea
TEL 82-51-240-2763
Email jpark@dau.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Jong-Hwan Park
Organization Dong-A University
Division name The Dong-A Anti-aging Research Institute
Zip code
Address 32, Daeshingongwon-Ro, Seo-Gu, Busan, 602-715
TEL +82-51-240-2763
Homepage URL
Email jpark@dau.ac.kr

Sponsor
Institute Dong-A University
Institute
Department

Funding Source
Organization Dong-A Univeristy
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
2016 Year 01 Month 20 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 Completed
Date of protocol fixation
2015 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 19 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
2015 Year 09 Month 07 Day
Last modified on
2016 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.