UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043059 |
|---|---|
| Receipt number | 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 | 2022/02/21 11:12:01 |
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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
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
k-tsutsu@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049164
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
