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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022671
Receipt No. R000026130
Scientific Title Effects of Movement Music Therapy with the Naruko Clapper on Physical Function and Frontal Lobe Function in Elderly Individuals with Mild Cognitive Impairment
Date of disclosure of the study information 2016/06/08
Last modified on 2016/06/08

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Basic information
Public title Effects of Movement Music Therapy with the Naruko Clapper on Physical Function and Frontal Lobe Function in Elderly Individuals with Mild Cognitive Impairment
Acronym Exercise Intervention for Mild Cognitive Impairment
Scientific Title Effects of Movement Music Therapy with the Naruko Clapper on Physical Function and Frontal Lobe Function in Elderly Individuals with Mild Cognitive Impairment
Scientific Title:Acronym Exercise Intervention for Mild Cognitive Impairment
Region
Japan

Condition
Condition in Elderly Individuals with Mild Cognitive Impairment
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The prefrontal cortex (PFC) is involved in executive function, and recent neuroimaging studies indicate that elderly individuals with mild cognitive impairment (MCI) show attenuated functional connectivity between the PFC and various brain regions. Here, we tested the hypothesis that performing a rhythmic physical task accompanied by a cognitive task, such as multitask movement music therapy (MMT) involving repetitive rhythmic movement with a musical instrument (the Naruko clapper), may improve PFC functions and cognitive performance. Thus, in elderly individuals with MCI, we assessed the effects of such MMT intervention on the activation of and blood flow in the frontal lobe and compared it with the effects of a non-rhythmic exercise routine without accompanying music or use of the Naruko clapper (single-task training [STT])
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1.Cognitive function tests
The frontal assessment battery (FAB)
Functional near-infrared spectroscopy (fNIRS)
The study was performed over a 14 weeks in July to October 2014. Data were collected on participant characteristics, physical indicators, and FAB score at each of the 3 study venues before and after the intervention. CBF was measured in sessions 1 and 12
Key secondary outcomes 1.Basic attributes
The household situation, main complaint, anamnesis, permission of the medical attendant, medicines taken, family, career, physical strength.
2.Physical indicators
Systolic blood pressure (SBP)
Diastolic blood pressure (DBP)
Body weight (BW)
Body balance
(one-leg standing with eyes open)
Flexibility (sit-and-reach test) Gait (maximum walking speed)
Muscle endurance
(30-Second Chair Stand Test)
Muscle strength
(grip strength in both hands)
Functional mobility
(timed Up & Go test)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 In the MMT intervention group,each MMT session started with a 30min warm-up exercise consisting of about 8 min of light exercise tailored to the BGM. The next 30 min involved exercises to the BGM that aimed to strengthen the leg muscles for fall prevention. This was followed by MMT using the Naruko clapper for 30 min to accompan "Yosakoi Icchorai Ondo", a song familiar to residents of Fukui Prefecture.Other familiar songs, such as the"365 Step March"and the"Hakodatenohito",were also used in the MMT group. The session ended with relaxation exercises as well as deep breathing and massage to accompanying BGM.
Interventions/Control_2 In the STT control group, an instructor guided the participants in the same exercises performed in the MMT group by giving counts only, without accompanying BGM or use of the Naruko clapper
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
84 years-old >=
Gender Male and Female
Key inclusion criteria Participants were those who voluntary took part in the 2014 preventive care class provided by the municipality of Eiheiji Town in Fukui Prefecture, Japan. They completed a preventive care checklist that focuses on memory impairment, which was constructed with reference to the definition of MCI.
Key exclusion criteria Final cerebral blood flow measurement not obtained or physical function test not conducted.Individuals requiring care were excluded
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuko Shimizu
Organization Ishikawa Prefectural Nursing University
Division name Dept.of Psychiatric and Mental Health Nursing
Zip code
Address 1-1,Gakuendai,Kahoku-City,Ishikawa,JAPAN.
TEL 076-281-8300
Email nshimizu@ishikawa-nu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuko Shimizu
Organization Ishikawa Prefectural Nursing University
Division name Dept.of Psychiatric and Mental Health Nursing
Zip code
Address 1-1,Gakuendai,Kahoku-City,Ishikawa,JAPAN.
TEL 076-281-8300
Homepage URL
Email nshimizu@ishikawa-nu.ac.jp

Sponsor
Institute Ishikawa Prefectural Nursing University
Dept.of Psychiatric and Mental Health Nursing
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science (JSPS), Grants-in-Aid for Scientific Research (KAKENHI)
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
Address
Tel
Email

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 福井県永平寺地域包括支援センター

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 08 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 Completed
Date of protocol fixation
2013 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2016 Year 11 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 04 Month 01 Day
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 08 Day
Last modified on
2016 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026130

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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