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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013445
Receipt No. R000015704
Scientific Title An evaluation of Sarcopenia as related loss of skeletal muscle and study of the curative effect for Sarcopenia patients
Date of disclosure of the study information 2014/03/17
Last modified on 2016/04/01

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Basic information
Public title An evaluation of Sarcopenia as related loss of skeletal muscle and study of the curative effect for Sarcopenia patients
Acronym Study of Sarcopenia
Scientific Title An evaluation of Sarcopenia as related loss of skeletal muscle and study of the curative effect for Sarcopenia patients
Scientific Title:Acronym Study of Sarcopenia
Region
Japan

Condition
Condition Life Style Related Diseases,
Myocardial Infarction, Heart Failure, Chronic respiratiory failure,Chronic
Renal Failure
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effects of the
training for the patients with
sarcopenia diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exercise Capacity, Muscle Power, Metabolic Function, Vascular Endothelial Function, Myokine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Resistance training in the health
science center for 3 months
Interventions/Control_2 Usual training at home for 3 months
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy Subjects, Patients with life style related diseases, Myocardial Infarction,Renal Failure and Chronic respiratoyt failure who decrease
their muscle volume
Key exclusion criteria disturbance of movement of extremities
,acute phase sickness,disturbance of joint
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Kimura
Organization Kansai Medical University
Division name Health Science Center
Zip code
Address Shinmachi 2-3-1, Hirakata, Osaka
TEL 072-804-2821
Email kimuray@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Kimura
Organization Kansai Medical University
Division name Health Science Center
Zip code
Address Shinmachi 2-3-1, Hirakata, Osaka
TEL 072-804-2821
Homepage URL
Email kimuray@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization None
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 関西医大健康科学センター

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 17 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 Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 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 03 Month 17 Day
Last modified on
2016 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015704

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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