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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034732
Receipt No. R000039557
Official scientific title of the study Effects of the Exercise Program with Humanoid Robot on Physical Performance and Cognitive Function among Community-Dwelling Elderly -Preliminary trial-
Date of disclosure of the study information 2018/11/05
Last modified on 2018/11/01

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Basic information
Official scientific title of the study Effects of the Exercise Program with Humanoid Robot on Physical Performance and Cognitive Function among Community-Dwelling Elderly -Preliminary trial-
Title of the study (Brief title) Effects of the Exercise Program with Robot on Physical and Cognitive Function
Region
Japan

Condition
Condition Healthy older adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects for physical and cognitive function by the exercise program with humanoid robot
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Physical function: systolic and diastolic blood pressure, body mass index, grip strength, one leg standing time, maximum gait speed, timed up and go test
Cognitive function: Mini-mental state examination score
Key secondary outcomes Blood test: TP, Alb, albumin/globulin ratio, TC, HDL-C, TG, AbA1c, BS, BDNF
Depressive mood:Geriatric depression scale

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 We will conduct the exercise program with humanoid robot during three months among community dwelling older adults. The exercise program includes two types of physical activity levels.
Interventions/Control_2 We will set control group who will participate in only health check-ups.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Community-dwelling older adults who live in Fujisawa city and/or Kamakura city, Kanagawa prefecture.
Key exclusion criteria Older adults who will not participate in the exercise program with humanoid robot constantly during three months.
Target sample size 20

Research contact person
Name of lead principal investigator chie Ishii
Organization Medical Corporation Association seishinkaiFujisawa Hospital
Division name Planning and Research Office
Address 383 Kozuca Fujisawa Kanagawa Japan
TEL 0466-23-2343
Email chie@fox.dti2.ne.jp

Public contact
Name of contact person Yumiko Kayanuma
Organization Medical Corporation Association seishinkaiFujisawa Hospital
Division name Planning and Research Office
Address 383 Kozuca Fujisawa Kanagawa Japan
TEL 0466-23-2343
Homepage URL
Email yumi_ishii@fhp.or.jp

Sponsor
Institute Medical Corporation Association seishinkaiFujisawa Hospital
Institute
Department

Funding Source
Organization FUJI SOFT INCORPORATED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 医療法人社団清心会 藤沢病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 05 Day

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 01 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results The general linear model showed significant improvement in maximum gait speed, timed up and go test, and mini mental state examination score after adjusting for baseline age, sex, and years of education among intervention group. Among control group, only mini mental state examination score showed significant improvement.
Other related information

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039557

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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