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

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 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

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

Value
https://center6.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