UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The contribution of myostatin related to the effects of exercise on bone metabolism in the elderly
Title of the study (Brief title)	The contribution of myostatin related to the effects of exercise on bone metabolism in the elderly
Region	Japan

Condition
Condition	the healthy elderly
Classification by specialty	Endocrinology and Metabolism Geriatrics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether exercise decreases blood myostatin level in the sedentary elderly and has favorable effects on the skeletal muscle mass, muscle strength and bone metabolism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	serum myostatin level
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	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	60 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	the healthy sedentary elderly
Key exclusion criteria	the subjects with arrythmia, history of ischemic heart disease, chronic heart failure, hypertension (with systolic BP of more than 160 mmHg, or diastolic BP of more than 100 mmHg at rest), chronic disease such as diabetes or renal dysfunction the subjects judged to be inappropriate for enrolled in the exercise program
Target sample size	40

Research contact person
Name of lead principal investigator	Hisayo Yokoyama
Organization	Osaka City University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
Address	3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL	06-6605-2947
Email	yokoyama@sports.osaka-cu.ac.jp

Public contact
Name of contact person	Hisayo Yokoyama
Organization	Osaka City University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
Address	3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL	06-6605-2947
Homepage URL
Email	yokoyama@sports.osaka-cu.ac.jp

Sponsor
Institute	Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine
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	TIPNESS Inc.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 01 Month 07 Day
Anticipated trial start date	2014 Year 03 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	Prospective case-controlled study. We will examine the changes in serum level of myostatin and other markers for bone metabolism in the healthy sedentary elderly following 3-month enrollong to an existing exercise program at Sumiyoshi Sports Center, comparing with the controll subjects with no participation to exercise.

Management information
Registered date	2014 Year 01 Month 07 Day
Last modified on	2016 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014922