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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012773
Receipt No. R000014922
Scientific Title The contribution of myostatin related to the effects of exercise on bone metabolism in the elderly
Date of disclosure of the study information 2014/04/01
Last modified on 2016/06/16

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Basic information
Public title The contribution of myostatin related to the effects of exercise on bone metabolism in the elderly
Acronym The contribution of myostatin related to the effects of exercise on bone metabolism in the elderly
Scientific Title The contribution of myostatin related to the effects of exercise on bone metabolism in the elderly
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Hisayo Yokoyama
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code
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
1st name
Middle name
Last name Hisayo Yokoyama
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code
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

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)

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
2014 Year 04 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 Main results already published
Date of protocol fixation
2014 Year 01 Month 07 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014922

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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