UMIN-CTR Clinical Trial

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
Email	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
Email	seino@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013385