UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013445 |
|---|---|
| Receipt number | 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 10:11:18 |
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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
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
kimuray@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015704
