UMIN-CTR Clinical Trial

Public title

Effects of community-based activity program on cognitive function in community-dwelling older adults with cognitive impairment: A randomized control trial

Acronym

A randomized control trial for reducing decline of cognitive functions in community-dwelling older adults

Scientific Title

Effects of community-based activity program on cognitive function in community-dwelling older adults with cognitive impairment: A randomized control trial

Scientific Title:Acronym

A randomized control trial for reducing decline of cognitive functions in community-dwelling older adults

Region

Japan

Condition

mild to moderate cognitive impairment

Classification by specialty

Geriatrics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of community-based activity program on cognitive function in older adults with mild to moderate cognitive impairment

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

National Center for Geriatrics and Gerontology-Functional Assessment Tool (NCGG-FAT):Attention, Memory, Executive function, processing speed

Key secondary outcomes

Brain volumetry: MRI
Physical function: muscle strength, gait, six-minute walk, balance
Life function: Tokyo Metropolitan Institute of Gerontology Index of Competence, fall experience
Psychological function: QOL, depression (GDS), sleep (PSQI), pain, apathy, social skill, self-efficacy
Activity level: Life-space assessment, social activity, steps and physical activity, social network

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group: exercise program in sport facilities (once a week) & small group (4 or 5 persons) activities in the community (about once a week) for 10 months

Interventions/Control_2

Control group: lecture on health (3 times per year)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Living in Midori Ward, Nagoya City
2) 70 years old or more at April of 2013
3) Score from 20 to 25 on the Mini-Mental State Examination
4) Give a written informed consent to the participation in the present study

Key exclusion criteria

1) Have serious or unstable illnesses
2) Have difficulty in gait
3) Participant in other studies

Target sample size

300

Name of lead principal investigator

1st name	Hiroyuki
Middle name
Last name	Shimada

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Preventive Gerontology

Zip code

474-8511

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture, 474-8511, Japan

TEL

0562-44-5651

Email

shimada@ncgg.go.jp

Name of contact person

1st name	Sangyoon
Middle name
Last name	Lee

Organization

National Center for Geriatrics and Gerontology

Division name

Section of Cohort Study for Longevity, Department of Preventive Gerontology

Zip code

474-8511

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture, 474-8511, Japan

TEL

0562-45-5638

Homepage URL

Email

sylee@ncgg.go.jp

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name

Organization

Japan science and technology agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Center for Geriatrics and Gerontology

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture, 474-8511, Japan

Tel

0562-46-2311

Email

sumiyami@ncgg.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

緑区や大府市内の施設

Date of disclosure of the study information

2014

Year

02

Month

07

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

280

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

Recruitment status

Main results already published

Date of protocol fixation

2014

Year

03

Month

20

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

02

Month

06

Day

Last modified on

2020

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015270