UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012773 |
|---|---|
| Receipt number | 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 10:28:46 |
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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
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
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
