UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018933
Receipt number 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 13:45:28

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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 or person

Institute

Dong-A University

Institute

Department

Personal name



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

Value
https://center6.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