UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011435 |
|---|---|
| Receipt number | R000013385 |
| Scientific Title | A cross-over trial for preventing frailty in the community dwelling older adults |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2020/05/22 11:11:29 |
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Basic information
Public title
A cross-over trial for preventing frailty in the community dwelling older adults
Acronym
A cross-over trial for preventing frailty
Scientific Title
A cross-over trial for preventing frailty in the community dwelling older adults
Scientific Title:Acronym
A cross-over trial for preventing frailty
Region
| Japan |
Condition
Condition
Frail older adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of multidimensional program combining exercise, nutrition and psychological interventions on frailty for the frail older adults.
We use combined data of our previous and present trials.
In additional study, we examine the effects of multidimensional program combining exercise, nutrition and psychological interventions on the risk of long-term care insurance certification, death and long-term care cost among community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty index
Quality of life
Tokyo Metropolitan Institute of Gerontology index of competence
Long-term care insurance certification (additional study)
Death (additional study)
Long-term care cost (additional study)
Key secondary outcomes
Physical functions: hand-grip strength, gait speed
Diversity of food intake
Self-efficacy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Providing multidimensional program combining exercise, nutrition, and psychological interventions for three-month period (22 sessions), and no intervention
Interventions/Control_2
No intervention, and providing multidimensional program combining exercise, nutrition, and psychological interventions for three-month period (22 sessions)
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) Living in Hatoyama Town, Saitama Prefecture
2) Participants of Hatoyama Cohort Study
3) Frailty index score of two or above
4) Give a written informed consent to the participation in the present study
Key exclusion criteria
1) Participating in health promotion activities routinely
2) Having serious or unstable illness
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Shinkai |
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name
Tokyo Metropolitan Institute of Gerontology
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
TEL
03-3964-3241
sshinkai@tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Seino |
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name
Tokyo Metropolitan Institute of Gerontology
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
TEL
03-3964-3241(4253)
Homepage URL
seino@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Hatoyama Town
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013385
| 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 |
