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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015548
Receipt No. R000018069
Scientific Title Exercise and nutrition intervention for the prevention of frailty in older adults: A randomized controlled trial
Date of disclosure of the study information 2014/10/31
Last modified on 2017/03/12

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Basic information
Public title Exercise and nutrition intervention for the prevention of frailty in older adults: A randomized controlled trial
Acronym Exercise and nutrition intervention for the prevention of frailty
Scientific Title Exercise and nutrition intervention for the prevention of frailty in older adults: A randomized controlled trial
Scientific Title:Acronym Exercise and nutrition intervention for the prevention of frailty
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether exercise and high protein and micro-nutrient supplementation more improve skeletal muscle mass and physical function than exercise alone in older adults.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body composition
Physical function
Key secondary outcomes Physical activity
Nutritional intake
Blood biochemical value
Weight
Body mass index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Strength training and walking program
Interventions/Control_2 Strength training and walking program
High protein and micro-nutrient supplementation
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Non-disabled person aged 65-80 years.
2) Person who can understand instruction.
Key exclusion criteria 1) Person who do moderate to vigorous physical activity more than 30 minutes, twice a week, and one year.
2) Person who deviate substantially from normal range of blood pressure and pulse.
3) Person who has irregular life style.
4) Person who has serious medical history, such as serious heart disease, kidney disease, liver disease, respiratory disease, or arthritis.
5) Person who deviate substantially from normal range of blood biochemical values.
6) Person who has food allergy or lactose intolerance.
7) Person who has restriction of protein intake.
8) Person who participated other clinical trial within 3-months.
9) Person who is judged inadequate for study subject.
Target sample size 80

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, Japan
TEL 03-3964-3241(4250)
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, Japan
TEL 03-3964-3241(4253)
Homepage URL
Email seino@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization Meiji CO., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 10 Month 31 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 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
2014 Year 10 Month 28 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018069

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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