UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017066 |
|---|---|
| Receipt number | 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 09:00:23 |
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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
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
bruckner@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine, Dementia Prevention and Therapeutics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019796
