UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of percussion performance and social dance on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial
Title of the study (Brief title)	A randomized control trial for preventing decline of cognitive functions in the elderly with MCI
Region	Japan

Condition
Condition	mild cognitive impairment
Classification by specialty	Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine the effects of cognitive activity on cognitive decline in elderly with mild cognitive impairment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function: Logical Memory, Word list memory
Key secondary outcomes	Cognitive function: Digit span, modified digit symbol substitution test, modified trail making test, backward counting Brain volumetry: MRI Physical function: muscle strength, gait analysis, six minutes walk, Activity: Japan Science and Technology Agency Instrumental activities of daily living scale, Life-space assessment, International Physical Activity Questionnaire, pedometer Health related characteristics: apathy, pain, fall, QOL, Pittsburgh Sleep Quality Index, fall efficacy scale, gait efficacy scale, social activity, Lubben Social Network Scale

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Social dance group for 10 months
Interventions/Control_2	Percussion performance group for 10 months
Interventions/Control_3	Control group: Lecture about disease and health (3 times during 10 months)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Elderly people, aged 70 over and living in Nagoya city, having health check from Jul to Des in 2013. 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) Needing long-term care
Target sample size	200

Research contact person
Name of lead principal investigator	Shimada Hiroyuki
Organization	National Center for Geriatrics and Gerontology
Division name	Center for Gerontology and Social Science
Address	35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL	0562-44-5651(5081)
Email	shimada@ncgg.go.jp

Public contact
Name of contact person	Tsutsumimoto Kota
Organization	National Center for Geriatrics and Gerontology
Division name	35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
Address	35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL	0562-44-5651(5081)
Homepage URL
Email	k-tsutsu@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Ministry of Education Science and Culture of Japan.

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	2014 Year 06 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 24 Day
Anticipated trial start date	2013 Year 12 Month 08 Day
Last follow-up date	2015 Year 01 Month 29 Day
Date of closure to data entry	2015 Year 02 Month 14 Day
Date trial data considered complete	2015 Year 02 Month 28 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 13 Day
Last modified on	2016 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016587