UMIN-CTR Clinical Trial

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, remission of sarcopenia of community-dwelling elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	remission of sarcopenia (%) Baseline. At the end of the intervention, 12 weeks after the end of the intervention, and 24 weeks after the end of the intervention.
Key secondary outcomes	skeletal muscle mass index, grip strength, knee extension strength, physical QOL Baseline. At the end of the intervention, 12 weeks after the end of the intervention, and 24 weeks after the end of the intervention.

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	>65 years old, Sarcopenia
Key exclusion criteria	There is an indication of the dietary restrictions from doctor. Without sarcopenia, Diabetes and chronic kidney disease, Severe dementia, dysphagia, Articular disease resistance training, intake protein supplement
Target sample size	81

Research contact person
Name of lead principal investigator	1st name Hiroyasu Middle name Last name Mori
Organization	Tokushima University
Division name	Diabetes Therapeutics and Research Center
Zip code	0886337587
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	0886337587
Email	hiroyam31@gmail.com

Public contact
Name of contact person	1st name Hiroyasu Middle name Last name Mori
Organization	Tokushima University
Division name	Diabetes Therapeutics and Research Center
Zip code	0886337587
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	0886337587
Homepage URL
Email	hiroyam31@gmail.com

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Tokushima 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	Tokushima University Hospital
Address	2-50-1, Kuramoto-cho, Tokushima
Tel	0886313111
Email	first-ec@tokushima-u.ac.jp

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	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027313