UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study on creation of diet and exercise therapy for sarcopenia treatment in community-dwelling elderly
Acronym	Diet and exercise intervention for sarcopenia treatment
Scientific Title	Intervention study on creation of diet and exercise therapy for sarcopenia treatment in community-dwelling elderly
Scientific Title:Acronym	Diet and exercise intervention for sarcopenia treatment
Region	Japan

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

Objectives
Narrative objectives1	We examine the effect of combined use of diet(mainly protein intake) and exercise therapy (mainlyresistance exercise) in elderly people who developed sarcopenia by intervention study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	sarcopenia, low SMI, low grip strength, slow gait speed, muscle mass, grip strength, gait speed, knee extension strength, physical QOL
Key secondary outcomes	fall, QOL,fall risk, nutritional status,ADL, energy and protein intake

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Resistance exercise twice a week and eating habitual dietary energy and protein ingestion, and whey protein supplementation intake after resistance exercises
Interventions/Control_2	Resistance exercise twice a week and eating habitual dietary energy and protein ingestion
Interventions/Control_3	Eating habitual dietary energy and protein ingestion, and whey protein supplementation intake
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	85 years-old >
Gender	Female
Key inclusion criteria	Applicant for Sarcopenia(diagnostic criteria of Asian Working Group for Sarcopenia. SMI, grip strength,gait speed < cutoff value) Community center, or care center.
Key exclusion criteria	Diabetes, CKD, liver disease, resistance trainded elderly, joint and motor dysfunction, dementia, difficult to eat meals
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Hiroyasu Middle name Last name Mori
Organization	Tokushima University
Division name	Institute of Advanced Medical Sciences
Zip code	7708503
Address	3-18-15, Kuramoto-cho, Tokushima, 770-8503
TEL	0886337587
Email	hiroyam31@gmail.com

Public contact
Name of contact person	1st name Hiroyasu Middle name Last name Mori
Organization	Hyogo University
Division name	Institute of Advanced Medical Sciences
Zip code	7708503
Address	3-18-15, Kuramoto-cho, Tokushima, 770-8503
TEL	0886337587
Homepage URL
Email	hiroyam31@gmail.com

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Ryo-syoku
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	University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address	kuramoto-cho 3-18-15, tokushima city
Tel	088-633-7587
Email	awachiken@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	2018 Year 09 Month 01 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	69
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	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 02 Month 02 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 25 Day
Last modified on	2022 Year 10 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035382