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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023713
Receipt No. R000027313
Scientific Title Effect of intake timing of protein, combined with a program of resistance exercises on the muscle mass and physical function of community-dewlling elderly
Date of disclosure of the study information 2016/08/29
Last modified on 2017/12/02

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Basic information
Public title Effect of intake timing of protein, combined with a program of resistance exercises on the muscle mass and physical function of community-dewlling elderly
Acronym Intervention study of the total protein intake and resistance exercise for sarcopenia prevention
Scientific Title Effect of intake timing of protein, combined with a program of resistance exercises on the muscle mass and physical function of community-dewlling elderly
Scientific Title:Acronym Intervention study of the total protein intake and resistance exercise for sarcopenia prevention
Region
Japan

Condition
Condition Sarcopenia
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of light-to-moderate resistance training combined with increased protein intake timing on the muscle mass, strength, and physical function of community-dwelling elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes muscle mass, grip strength, knee extension strength
Key secondary outcomes

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 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 resistance band exercise peformed 2 times per week for 24 week
Interventions/Control_2 resistance band exercise and protein intake timing peformed 2 times per week for 24 week
Interventions/Control_3 protein intake timing peformed 2 times per week for 24 week
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 Female
Key inclusion criteria Capable of performing a nutritional survey elderly
Key exclusion criteria There is an indication of the dietary and exercise restrictions from doctor
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunobu Tokuda
Organization Hyogo University
Division name Faculty of Health Science
Zip code
Address 2301 Arazaike, Hiraoka-cho Kakogawa City, Hyogo
TEL 0794275111
Email hiroyam31@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasunobu Tokuda
Organization Hyogo University
Division name Faculty of Health Science
Zip code
Address 2301 Arazaike, Hiraoka-cho Kakogawa City, Hyogo
TEL 0794275111
Homepage URL
Email hiroyam31@gmail.com

Sponsor
Institute Hyogo University
Institute
Department

Funding Source
Organization Hyogo university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2016 Year 08 Month 29 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 Main results already published
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 15 Day
Last follow-up date
2016 Year 05 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 06 Month 01 Day
Date analysis concluded
2017 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 22 Day
Last modified on
2017 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027313

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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