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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017066
Receipt No. R000019796
Scientific Title The effect of exercise with music accompaniment to patients with dementia
Date of disclosure of the study information 2015/05/31
Last modified on 2019/10/11

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Basic information
Public title The effect of exercise with music accompaniment to patients with dementia
Acronym Exercise with music to dementia
Scientific Title The effect of exercise with music accompaniment to patients with dementia
Scientific Title:Acronym Exercise with music to dementia
Region
Japan

Condition
Condition demnetia
Classification by specialty
Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of exercise with music to dementia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neuropsychological assessment
Key secondary outcomes Brain imaging

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Carry out the exercise with music for a hour one a week.
Interventions/Control_2 Carry out the sognitive stimulation therapy for a hour one a week.
Interventions/Control_3
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. dementia
2. Living in nursing home or utilizing the day service.
3. The presence of caregiver(s) who know(s) daily living of the patient.
Key exclusion criteria 1. BPSD which prevent from performing the assessments or intervention.
2. Not allowed to do exercise due to other diseases (ex, ischemic heart disese).
3. The absence of of caregiver(s) who know(s) daily living of the patient.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Masayuki
Organization Graduate School of Medicine, Mie University
Division name Dementia Prevention and Therapeutics
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie 514-8507
TEL 059-231-6027
Email bruckner@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Masayuki
Organization Graduate School of Medicine, Mie University
Division name Dementia Prevention and Therapeutics
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie 514-8507
TEL 059-231-6027
Homepage URL
Email bruckner@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University, Graduate School of Medicine, Dementia Prevention and Therapeutics
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research ethics committiee of Kinan Hospital
Address 4750 Atawa, Mihama town, Minami-Murou-Gun, Mie
Tel 05979-2-1333
Email jimubu-mitsuisi@outlook.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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 31 Day
Date of IRB
2015 Year 05 Month 13 Day
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2033 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 07 Day
Last modified on
2019 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019796

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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