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)
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
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
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
