UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dementia prevention for community-dwelling elderly people using physical exercise with music accompaniment: Mihama/Kiho Project
Title of the study (Brief title)	Mihama/Kiho Project
Region	Japan

Condition
Condition	community-dwelling normal elderly people
Classification by specialty	Neurology Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Neuropsychological assessment (intellect, memory, frontal function)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Other
Interventions/Control_1	Physical exercise with music accompaniment, using music therapy
Interventions/Control_2	Physical exercise without music accompaniment
Interventions/Control_3	control
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(a) over 65 years old, (b) in physically and psychologically healthy condition, (c) having corrected vision, (d) ability to clearly hear instructions, (e) living independently, and (f) able to be present once a week at the place of exercise.
Key exclusion criteria	(a) apparent history of cerebrovascular attack, (b) the presence of chronic exhausting disease such as malignancy and infection, (c) the presence of severe cardiac, respiratory, and/or orthopedic disabilities which would prevent subjects from participating in exercise, (d) taking drugs that might adversely affect cognition (antidepressants and antipsychotics), and (e) having been diagnosed with dementia.
Target sample size	120

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

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

Funding Source
Organization	Department of Dementia Prevention and Therapeutics, Graduate School of Medicine, Mie University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mihama Town, Kiho Town, Kinan Hospital
Name of secondary funｄer(s)

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	2013 Year 10 Month 28 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 06 Month 15 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 28 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014201