UMIN-CTR Clinical Trial

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