UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012148 |
|---|---|
| Receipt number | R000014201 |
| Scientific Title | Dementia prevention for community-dwelling elderly people using physical exercise with music accompaniment: Mihama/Kiho Project |
| Date of disclosure of the study information | 2013/10/28 |
| Last modified on | 2017/11/10 10:08:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Dementia prevention for community-dwelling elderly people using physical exercise with music accompaniment: Mihama/Kiho Project
Acronym
Mihama/Kiho Project
Scientific Title
Dementia prevention for community-dwelling elderly people using physical exercise with music accompaniment: Mihama/Kiho Project
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masayuki Satoh |
Organization
Graduate School of Medicine, Mie University
Division name
Dementia Prevention and Therapeutics
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507
TEL
059-231-6027
bruckner@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Satoh |
Organization
Graduate School of Medicine, Mie University
Division name
Dementia Prevention and Therapeutics
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507
TEL
059-231-6027
Homepage URL
bruckner@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Dementia Prevention and Therapeutics, Graduate School of Medicine, Mie University
Institute
Department
Personal name
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)
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
| 2013 | Year | 10 | Month | 28 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 06 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014201
