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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030992
Receipt No. R000035382
Scientific Title Intervention study on creation of diet and exercise therapy for sarcopenia treatment in community-dwelling elderly
Date of disclosure of the study information 2018/09/01
Last modified on 2019/07/31

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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 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes muscle mass, grip strength, gait speed, knee extension strength, balance ability
Key secondary outcomes fall, QOL,fall risk, nutritional status,ADL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
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 protein ingestion, and protein supplementation intake after resistance exercises
Interventions/Control_2 Resistance exercise twice a week
Interventions/Control_3 eating habitual dietary protein ingestion
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)
Key exclusion criteria Diabetes, CKD, Obesity, liver disease, lower intake protein amount, 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
Middle name
Last name Yasunobu Tokuda
Organization Hyogo University
Division name Faculty of Health Science
Zip code
Address 2301 Arazaike, Hiraoka, Kakogawa, Hyogo 675-0195, Japan
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, Kakogawa, Hyogo 675-0195,
TEL 0794275111
Homepage URL
Email hiroyam31@gmail.com

Sponsor
Institute Hyogo University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
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
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 No longer recruiting
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
2020 Year 03 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
2019 Year 07 Month 31 Day


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

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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