UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015548 |
|---|---|
| Receipt number | 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 22:25:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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)
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
seino@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018069
