UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014261
Receipt number R000016587
Scientific Title Effects of percussion performance and social dance on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial
Date of disclosure of the study information 2014/06/13
Last modified on 2016/06/23 22:08:31

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Basic information

Public title

Effects of percussion performance and social dance 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 percussion performance and social dance 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

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


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



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

1st name
Middle name
Last name Shimada Hiroyuki

Organization

National Center for Geriatrics and Gerontology

Division name

Center for Gerontology and Social Science

Zip code


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

1st name
Middle name
Last name Tsutsumimoto Kota

Organization

National Center for Geriatrics and Gerontology

Division name

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

Zip code


Address

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

TEL

0562-44-5651(5081)

Homepage URL


Email

k-tsutsu@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



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.


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



Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 13 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

Completed

Date of protocol fixation

2012 Year 12 Month 24 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016587


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name