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

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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 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


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

Value
https://center6.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