UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000019796