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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038740
Receipt No. R000044161
Scientific Title Improvement in Cognitive and Motor Functions of Healthy Older Adults Following a Dance Program Intervention: A Randomized Controlled Trial
Date of disclosure of the study information 2019/11/29
Last modified on 2019/11/29

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Basic information
Public title Improvement in Cognitive and Motor Functions of Healthy Older Adults Following a Dance Program Intervention: A Randomized Controlled Trial
Acronym Cognitive and Motor Functions Following a Dance Program Intervention
Scientific Title Improvement in Cognitive and Motor Functions of Healthy Older Adults Following a Dance Program Intervention: A Randomized Controlled Trial
Scientific Title:Acronym Cognitive and Motor Functions Following a Dance Program Intervention
Region
Japan

Condition
Condition Dementia, Mild Cognitive Impairment, Normal elderly, Lewy body dementia, Cerebrovascular disease, Cerebral infarction, Cerebral contusion, Cerebral hemorrhage, Aftereffect of cerebral hemorrhage, Basilar artery occlusion, Cerebral arteriosclerosis, Multiple cerebral infarction, Cerebral atrophy, Vascular dementia, Chronic subdural hematoma, Parkinson's disease, Parkinsonian syndrome, Bone and joint disease, Osteoporosls, Chronic articular rheumatism, Hemiparesis, Diabetes, Disuse syndrome, Locomotive Syndrome, Sarcopenia and frailty.
Classification by specialty
Psychiatry Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the beneficial effect on cognitive and physical function by the dance program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Stroop test is compared before and after intervention for four weeks.
Key secondary outcomes The neuropsychological testing and assessment for dementia (Mini-Mental State Examination, Instruction manual of the Japanese version of Montreal Cognitive Assessment, A Frontal Assessment Battery at bedside), Geriatric Depression Scale, WHO Quality of Life-BREF, the range of motion of the upper and lower limbs, the short physical performance battery test (balance testing, walk for 4 meters, repeated chair stands), grip strength, toe strength, standing calf raise test, bioelectrical impedance analysis (muscle mass (kg), skeletal muscle mass index (kg/m2), ECW/TBW), and respiratory function test (FVC, FEV1, FIV1).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The dance intervention group attends 45 minutes of the dance program thrice a week for 4 weeks. After each program, take 8g of protein-containing food.
Interventions/Control_2 The walking intervention group attends 45 minutes of a nordic walking program thrice a week for 4 weeks. After each program, take 8g of protein-containing food.
Interventions/Control_3 The wait listed group does not participate in the intervention. Take 8g of protein-containing food 3 times a week. After 4 weeks, there is the program as a service session.
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) No dementia.
2) No exercised more than an hour per week.
3) Continue to participate in the experiment for 4 weeks.
4) No heart disease, no respiratory disease.
5) Understand Japanese.
Key exclusion criteria 1) Dementia, heart disease and respiratory disease.
2) Blind, full deafness.
3) Regular exercise or training at least once a week.
4) Cannot walk for 45 minutes.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Atsuko
Middle name
Last name Miyazaki
Organization RIKEN
Division name Computational Engineering Applications Unit
Zip code 351-0198
Address 2-1 Hirosawa, Wako, Saitama 351-0198 Japan
TEL +81(0)48-467-4952
Email atsuko.miyazaki.vj@riken.jp

Public contact
Name of contact person
1st name Atsuko
Middle name
Last name Miyazaki
Organization RIKEN
Division name Computational Engineering Applications Unit
Zip code 351-0198
Address 2-1 Hirosawa, Wako, Saitama 351-0198 Japan
TEL +81(0)48-467-4952
Homepage URL
Email atsuko.miyazaki.vj@riken.jp

Sponsor
Institute RIKEN
Institute
Department

Funding Source
Organization Avex Entertainment Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization RIKEN, Bio Safety and Ethics Section
Address 2-1 Hirosawa, Wako, Saitama 351-0198 Japan
Tel 048-467-9293
Email human@riken.jp

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 株式会社 AT (神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 29 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 29 Day
Date of IRB
2019 Year 11 Month 29 Day
Anticipated trial start date
2019 Year 12 Month 09 Day
Last follow-up date
2020 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044161

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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