UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014005 |
|---|---|
| Receipt number | R000016298 |
| Scientific Title | The effects of exercise on muscle strength and bone metabolism in maintenance hemodialysis patients -the contribution of myostatin, a peptide derived from skeletal muscle- |
| Date of disclosure of the study information | 2014/05/21 |
| Last modified on | 2015/08/13 09:56:34 |
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Basic information
Public title
The effects of exercise on muscle strength and bone metabolism in maintenance hemodialysis patients -the contribution of myostatin, a peptide derived from skeletal muscle-
Acronym
The contribution of myostatin to the effects of exercise on muscle strength and bone metabolism in maintenance hemodialysis patients
Scientific Title
The effects of exercise on muscle strength and bone metabolism in maintenance hemodialysis patients -the contribution of myostatin, a peptide derived from skeletal muscle-
Scientific Title:Acronym
The contribution of myostatin to the effects of exercise on muscle strength and bone metabolism in maintenance hemodialysis patients
Region
| Japan |
Condition
Condition
maintenance hemodialysis patients
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the exercise training reduces the serum level of myostatin, and has the effect on muscle strength and bone metabolism in maintenance hemodialysis patients with low physical activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum myostatin level
Key secondary outcomes
bone mineral density of calcaneus, peak oxygen uptake, muscle mass of lower limb, muscle strength of quadriceps muscle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
intradialytic aerobic exercise and resistance training
3 sessions of 1 hour exercise per week
12 weeks
Interventions/Control_2
no exercise
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Maintenance hemodialysis patients at stable period with over 6 months passed from the initiation of the therapy.
Patients receiving adequate hemodialysis (Kt/V is 1.2 and more) with stable blood pressure during the therapy, and the ability to walk over 50 m by themselves.
Key exclusion criteria
patients with diabetes, orthopedic disorders, abnormal findings such as ischemic change or severe arrhythmia on cardiopulmonary exercise test, heart failure on echocardiography (ejection fraction<50%).
patients considered as inappropriate to participate in exercise by doctor.
Target sample size
20
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
Osaka City University Graduate School of Medicine, Environmental Physiology for Exercise
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jinshinkai, Shirasagi Hospital
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 | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | 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 | 05 | Month | 20 | Day |
Last modified on
| 2015 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016298
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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