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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043059
Receipt No. R000049164
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
Date of disclosure of the study information 2021/01/21
Last modified on 2021/01/20

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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
2023 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
2021 Year 01 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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