UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008105 |
|---|---|
| Receipt number | 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 | 2022/06/13 10:03:53 |
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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
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
kimura.misaka@kuas.ac.jp
Sponsor or person
Institute
Institute of Interdisciplinary Research,
Kyoto University of Advanced Science
Institute
Department
Personal name
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
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
| 2012 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
