UMIN-CTR Clinical Trial

Public title

Effects of exercise on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial

Acronym

A randomized control trial for preventing decline of cognitive functions in the elderly with MCI

Scientific Title

Effects of exercise on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial

Scientific Title:Acronym

A randomized control trial for preventing decline of cognitive functions in the elderly with MCI

Region

Japan

Condition

mild cognitive impairment

Classification by specialty

Geriatrics

Psychiatry

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To examine the effects of physical exercise on cognitive decline in elderly with mild cognitive impairment.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cognitive function: Wechsler Memory Scale-Revised Logical Memory , Rey Auditory Verbal Learning Test, word list memory

Key secondary outcomes

Cognitive function: Digit span, modified digit symbol substitution test, verbal fluency, modified trail making test, flanker test, backward counting
Brain volumetry: MRI
Brain function: FDG PET and fNIRS
Physical function: muscle strength, gait analysis, six minutes walk, balance control
Activity: Tokyo Metropolitan Institute of Gerontology Index of Competence, Life-space assessment, Physical Activity Scale for the Elderly, pedometer
Health related characteristics: apathy, pain, fall, QOL, Pittsburgh Sleep Quality Index, fall efficacy scale, gait efficacy scale, social activity

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group: Supervised exercise for 1 year

Interventions/Control_2

Control group: Lecture about disease and 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

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Elderly people, aged 65 over and living in Obu city, having health check from Aug in 2011 to Feb in 2012.
2) Fullfilled Peterson's criteria (a: cognitive function is 1.5 SD or more below the normative values; b: score of more than 24 on the Mini-Mental State Examination; c: not diagnosed dementia; d: being independent in activity of daily living; e: having a complain of subjective memory problem)
3) Being agreed with participation in the study

Key exclusion criteria

1) Having serious or unstable illnesses
2) History of psychiatric disease
3) Receiving of anti-Alzheimer drugs
4) Geriatrics Depression Scale > 5
5) Needing long-term care

Target sample size

308

Name of lead principal investigator

1st name
Middle name
Last name	Suzuki Takao

Organization

National Center for Geriatrics and Gerontology

Division name

Research Institute

Zip code

Address

35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan

TEL

0562445651

Email

jiritsu@ncgg.go.jp

Name of contact person

1st name
Middle name
Last name	Shimada Hiroyuki

Organization

National Center for Geriatrics and Gerontology

Division name

Department for Research and Development to Support Independent Life of Elderly

Zip code

Address

35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan

TEL

0562445651

Homepage URL

Email

jiritsu@ncgg.go.jp

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare (Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Ministry of Education Science and Culture of Japan.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大府市市内の施設

Date of disclosure of the study information

2012

Year

04

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2011

Year

12

Month

24

Day

Date of IRB

Anticipated trial start date

2012

Year

01

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

2012

Year

04

Month

13

Day

Last modified on

2016

Year

04

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009121