UMIN-CTR Clinical Trial

Basic information
Public title	The verification of training effect with a balance exercise assist robot on motor functions and frail
Acronym	The effect of balance exercise assist robot
Scientific Title	The verification of training effect with a balance exercise assist robot on motor functions and frail
Scientific Title:Acronym	The effect of balance exercise assist robot
Region	Japan

Condition
Condition	Frail or pre-frail elderly
Classification by specialty	Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim is the verification of training effect with a balance exercise assist robot on motor functions and frailty
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Timed Up and Go test (TUG)
Key secondary outcomes	FRT: Functional Reach Test SPPB: Short Physical Performance Battery muscle strength (grip, length) Exercise habit falls experience LSA: Life Space Assessment BDHQ: Brief-type self-administered diet history questionnaire FES: Fall Efficacy Scale VI: Vitality Index GDS: Geriatrics Depression Scale Assessment of Sarcopenia (AWGS criteria) Blood data (TP, Alb, pre-Alb, CK, BUN, Cre)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom Maneuver
Interventions/Control_1	Robot exercise group: Balance exercise using balancing exercise assist robot (2 times / week for 2 months)
Interventions/Control_2	Physical therapy group: Muscle exercise and balance exercise (2 times / week for 2 months)
Interventions/Control_3	Exercise instruction group: Exercise guidance (once / month for 2 months)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The subjects are introduced to the Department of Rehabilitation, among elderly people who are visiting our Center for Locomo Frail Outpatient. Selection criteria are elderly people aged 65 years or older who can walk independence.
Key exclusion criteria	High-blood pressure(systolic blood pressure>=180 mmHg or diastolic blood pressure>=120 mmHg or resting heart rate>=120/min) Restricted by movement due to heart function or respiratory function disorder hearing or visual impairment Dementia or severe higher brain dysfunction
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Izumi Middle name Last name Kondo
Organization	National Center for Geriatrics and Gerontology
Division name	Rehabilitation Center
Zip code	474-8511
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL	0562-46-2311
Email	ik7710@ncgg.go.jp

Public contact
Name of contact person	1st name Izumi Middle name Last name Kondo
Organization	National Center for Geriatrics and Gerontology
Division name	Rehabilitation Center
Zip code	474-8511
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL	0562-46-2311
Homepage URL
Email	ik7710@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	TOYOTA motors
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	The clinical research ethics committee in National Center for Geriatrics and Gerontology
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
Tel	0562-46-2311
Email	rehab@ncgg.go.jp

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

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 27 Day

Related information
URL releasing protocol	https://jrct.niph.go.jp/re/reports/detail/1037
Publication of results	Partially published

Result
URL related to results and publications	https://jrct.niph.go.jp/re/bulletins/detail/932/4503
Number of participants that the trial has enrolled	79
Results	The results of the interim analysis suggest that muscle strength and some balance ability can be However, the results of the interim analysis also suggested that the home-based exercise program However, the number of times of voluntary exercise at home, which was also taught, tended to decrease gradually from the time of the start of the program, leaving some issues to be solved for the long-term establishment of voluntary exercise.
Results date posted	2022 Year 09 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 04 Month 01 Day
Baseline Characteristics	To date, 79 patients (mean age 78.5+-6.1 years, 28 males/51 females, BEAR group: 28, outpatient rehabilitation group: 26, exercise instruction group: 25) have been entered and the intervention was implemented.
Participant flow	Elderly patients who visit the outpatient locomotor frailty clinic at our center and who are referred to the Department of Rehabilitation Medicine are eligible for this study. Selection criteria are as follows: elderly patients aged 65 years or older, regardless of gender, capable of independent walking, and informed consent has been obtained.
Adverse events	none.
Outcome measures	Primary endpoints Postural balance ability (Timed Up and Go test: TUG) Secondary endpoints Postural balance ability, lower limb muscle strength, (Functional Reach Test: FRT, Short Physical Performance Battery: SPPB, and Knee Extensor Strength), Exercise Habits (Exercise Time and Frequency as recorded in the Self-Training Checklist), Falls Survey (no falls in the past year at the start of the study, no falls during the study period as recorded in the Health Handbook), Life Span Assessment (LSA), Nutritional Assessment (BDHQ: Brief- type self-administered diet history questionnaire), fear of falling (FES: Fall Efficacy Scale), motivation and affect (Vitality Index: VI, Geriatrics Depression Scale: GDS), and SarcoEvaluation of penia (limb skeletal muscle mass by BIA method, 10 m), comfortable walking speed, grip strength), general biochemical data (blood volume drawn: 14 ml per test; TP, Alb, pre-Alb, CK, BUN, Cre)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 21 Day
Date of IRB	2017 Year 07 Month 21 Day
Anticipated trial start date	2017 Year 07 Month 21 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Since this study falls under the category of specific clinical research, we will continue to disclose information on the progress of the study on jRCT. https://jrct.niph.go.jp/re/reports/detail/1037

Management information
Registered date	2018 Year 11 Month 27 Day
Last modified on	2022 Year 09 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039944