UMIN-CTR Clinical Trial

Basic information
Public title	A randomized control trial of dual task ergometer exercise program at home for physical activity in the older people
Acronym	A randomized control trial of dual task ergometer exercise program for physical activity in the older adults
Scientific Title	Effects of dual task ergometer exercise program at home on physical activity in the older people with physical activity: a randomized controlled trial
Scientific Title:Acronym	A randomized control trial for increasing physical activity in the older people with physical frailty
Region	Japan

Condition
Condition	physical frailty, physical pre-frailty
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate Effects of ergometer exercise program at home on physical activity in the older people with physical activity
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical activity
Key secondary outcomes	physical function (muscle strength, walking speed), psychological state (depressive symptoms), life style factor (drinking habit, smoking habit, sleep),incident disability

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Home exercise program using a dual task ergometer
Interventions/Control_2	lecture about disease and health
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) older people, aged 65 over and living in community 2) Those who have not been certified as long-term care 3) Those who can listen to and understand the content of the research 4) Being agreed with participation in the study 5) Full filled following J-CHS criteria (a: slow gait speed b: muscle weakness; c: exhaustion d: weight loss, e: decline in physical activity)
Key exclusion criteria	1) Those with serious or unstable illnesses; dementia, stoke and Parkinson's disease 2) Those who are contraindicated in exercise 3) Those who are unable to walk independently 4) Those for whom the person in charge judges that it is better to stop the implementation from the standpoint of safety 5) Those who have been hospitalized within the past 3 months
Target sample size	314

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Shimada
Organization	National Center for Geriatrics and Gerontology
Division name	Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430, Morioka-cho, Obu, Aichi
TEL	0562-87-1285
Email	shimada@ncgg.go.jp

Public contact
Name of contact person	1st name Kota Middle name Last name Tsutsumimoto
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
Zip code	474-8511
Address	7-430, Morioka-cho, Obu, Aichi
TEL	0562-87-1285
Homepage URL
Email	k-tsutsu@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430, Morioka-cho, Obu, Aichi
Tel	0562-46-2311(4683)
Email	yaday@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	2021 Year 01 Month 21 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
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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 21 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 20 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049164