UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An evaluation of Sarcopenia as related loss of skeletal muscle and study of the curative effect for Sarcopenia patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yutaka Kimura
Organization	Kansai Medical University
Division name	Health Science Center
Address	Shinmachi 2-3-1, Hirakata, Osaka
TEL	072-804-2821
Email	kimuray@hirakata.kmu.ac.jp

Public contact
Name of contact person	Yutaka Kimura
Organization	Kansai Medical University
Division name	Health Science Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/icdr_e/ctr_view.cgi?recptno=R000015704