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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008105
Receipt No. R000009540
Scientific Title The effect of a multiple care prevention program with exercise on sarcopenia, physical function, and medical and care cost in the elderly
Date of disclosure of the study information 2012/06/05
Last modified on 2020/08/14

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Basic information
Public title The effect of a multiple care prevention program with exercise on sarcopenia, physical function, and medical and care cost in the elderly
Acronym The effect of care prevention program in the elderly
Scientific Title The effect of a multiple care prevention program with exercise on sarcopenia, physical function, and medical and care cost in the elderly
Scientific Title:Acronym The effect of care prevention program in the elderly
Region
Japan

Condition
Condition Prevention of care need status
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of a multiple care prevention program with exercise on sarcopenia, physical funtion, and medical and care cost.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Medical and care cost
Key secondary outcomes sarcopenia; muscle mass, muscle strength, and physical funtion (i.e. gait speed)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Three-month exercise and one-year diary intervention with behavioral change with oral care and dietary and exercise habits
Interventions/Control_2 one-year diary intervention with behavioral change with oral care and dietary and exercise habits
Interventions/Control_3 No treatment
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 community-dwelling elderly without care-need in Kameoka-shi, Kyoto, Japan
Key exclusion criteria The person who has exercise contraindication
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Misaka
Middle name
Last name Kimura
Organization Kyoto University of Advanced Science
Division name Institute of Interdisciplinary Research
Zip code 6158111
Address 1-1 Nanjyo-Otani, Sogabe, Kameoka, Kyoto,
TEL 0771292393
Email kimura.misaka@kuas.ac.jp

Public contact
Name of contact person
1st name Misaka
Middle name
Last name Kimura
Organization Kyoto University of Advanced Science
Division name Institute of Interdisciplinary Research
Zip code 621-8555
Address 1-1 Nanjyo-Otani, Sogabe, Kameoka, Kyoto,
TEL 0771-56-8930
Homepage URL
Email kimura.misaka@kuas.ac.jp

Sponsor
Institute Institute of Interdisciplinary Research,
Kyoto University of Advanced Science
Institute
Department

Funding Source
Organization Institute of Interdisciplinary Research,
Kyoto University of Advanced Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Kyoto University of Advanced Science
Address Gotannda-cho, Yamanouchi, Ukyo-ku, Kyoto, Japan
Tel 075-406-9210
Email shibata.masamitsu@kuas.ac.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
2012 Year 06 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 1000
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 03 Month 31 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 05 Day
Last modified on
2020 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009540

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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