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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014005
Receipt No. 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

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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
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 Osaka City University Graduate School of Medicine, Environmental Physiology for Exercise
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016298

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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