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
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
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
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
