UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014437
Receipt number R000016788
Scientific Title Development and validation of intervention program for prevention of dementia in community-dwelling older adults
Date of disclosure of the study information 2014/07/04
Last modified on 2021/03/22 15:08:03

* 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

Development and validation of intervention program for prevention of dementia in community-dwelling older adults

Acronym

Development and validation of intervention program for prevention of dementia in community-dwelling older adults

Scientific Title

Development and validation of intervention program for prevention of dementia in community-dwelling older adults

Scientific Title:Acronym

Development and validation of intervention program for prevention of dementia in community-dwelling older adults

Region

Japan


Condition

Condition

Older adults with cognitive complaints

Classification by specialty

Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of intervention programs including different exercises on cognitive function in older adults with cognitive complaints.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive function: Wechsler Memory Scale-Revised, Trail making test, Verbal fluency test, Stroop test, Digit symbol substitution test

Key secondary outcomes

Cognitive function:Mini-Mental State Examination, ADAS-J-cog, Rey Auditory Verbal Learning Test, Montreal Cognitive Assessment, Clock Drawing test, Frontal Assessment Battery, Wisconsin card sorting test, Rey complex figure test

Physical function: muscle strength, gait analysis, six minutes walk, balance function
Body composition: Skeletal muscle mass, amount of body fat
Activity: Life-space assessment, International Physical Activity Questionnaire, pedometer, Tokyo Metropolitan Institute of Gerontology Index of Competence
Health related characteristics: Geriatric Depression Scale, Apathy scale, fall, QOL, Fall efficacy scale, Lubben Social Network Scale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment



Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Aerobic training group: supervised aerobic training for 6 months

Interventions/Control_2

Resistance training group: supervised resistance training for 6 months

Interventions/Control_3

Aerobic and resistance training group: supervised aerobic and resistance training for 6 months

Interventions/Control_4

Control group: Lecture about disease and health (2 times per 6 months)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Having cognitive complaints
2. Being independent in activity of daily livin
3. Being agreed with participation in the study

Key exclusion criteria

1. Diagnosed as dementia
2. History of cerebrovascular disease
3. Having serious disease which requires exercise limitation (i.e., cardiovascular, respiratory, neurological, ophthalmic, orthopedic disease )
4. Needing long-term care

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Kuzuya

Organization

Nagoya University

Division name

Department of Community Healthcare & Geriatrics, Graduate School of Medicine

Zip code


Address

65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan

TEL

052-744-2369

Email

kuzuya@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Umegaki

Organization

Nagoya University

Division name

Department of Community Healthcare & Geriatrics, Graduate School of Medicine

Zip code


Address

65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan

TEL

052-744-2364

Homepage URL


Email

umegaki@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Toyota City Hall

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

豊田市内の施設(愛知県)


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 04 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

Enrolling by invitation

Date of protocol fixation

2014 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 11 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 07 Month 01 Day

Last modified on

2021 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name