UMIN-CTR Clinical Trial

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
Institute	Nagoya University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016788