UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006328 |
|---|---|
| Receipt number | R000007441 |
| Scientific Title | A randomized control trial for preventing frailty in the community dwelling elderly |
| Date of disclosure of the study information | 2011/09/13 |
| Last modified on | 2021/03/20 10:00:26 |
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Basic information
Public title
A randomized control trial for preventing frailty in the community dwelling elderly
Acronym
A randomized control trial for preventing frailty in the elderly
Scientific Title
A randomized control trial for preventing frailty in the community dwelling elderly
Scientific Title:Acronym
A randomized control trial for preventing frailty in the elderly
Region
| Japan |
Condition
Condition
Frailty
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 psychosocial interventions on frailty for the frail elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty index, Quality of life, TMIG-Index of competence
Key secondary outcomes
Physical functions (grip strength, gait performance), 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 psychosocial interventions for three-month period (22 sessions) -> No intervention
Interventions/Control_2
No intervention -> Providing multidimensional program combining exercise, nutrition and psychosocial 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
| 85 | years-old | >= |
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) Those who gave written informed consent forms
Key exclusion criteria
1) Participating in health promotion activities routinely
2) Having serious or unstable illness
Target sample size
70
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Murayama |
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
Homepage URL
murayama@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)
Research Institute of Science and Technology for Society
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
鳩山ふれあいセンター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 13 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | 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
| 2011 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007441
