UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022671 |
|---|---|
| Receipt number | 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 20:53:55 |
* 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
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
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
nshimizu@ishikawa-nu.ac.jp
Sponsor or person
Institute
Ishikawa Prefectural Nursing University
Dept.of Psychiatric and Mental Health Nursing
Institute
Department
Personal name
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
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
Value
https://center6.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 |
