UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034732
Receipt number R000039557
Scientific Title 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 09:37:55

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Basic information

Public title

Effects of the Exercise Program with Humanoid Robot on Physical Performance and Cognitive Function among Community-Dwelling Elderly -Preliminary trial-

Acronym

Effects of the Exercise Program with Robot on Physical and Cognitive Function

Scientific Title

Effects of the Exercise Program with Humanoid Robot on Physical Performance and Cognitive Function among Community-Dwelling Elderly -Preliminary trial-

Scientific Title:Acronym

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

1st name
Middle name
Last name chie Ishii

Organization

Medical Corporation Association seishinkaiFujisawa Hospital

Division name

Planning and Research Office

Zip code


Address

383 Kozuca Fujisawa Kanagawa Japan

TEL

0466-23-2343

Email

chie@fox.dti2.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yumiko Kayanuma

Organization

Medical Corporation Association seishinkaiFujisawa Hospital

Division name

Planning and Research Office

Zip code


Address

383 Kozuca Fujisawa Kanagawa Japan

TEL

0466-23-2343

Homepage URL


Email

yumi_ishii@fhp.or.jp


Sponsor or person

Institute

Medical Corporation Association seishinkaiFujisawa Hospital

Institute

Department

Personal name



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)



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

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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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.

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

2014 Year 01 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.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
Registered date File name