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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041181
Receipt No. R000047021
Scientific Title Effectiveness of the exercise training therapy for the dialysis dependent end-stage renal disease patients and the myokines, which is skeletal muscle derived physiologically active substance
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/21

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Basic information
Public title Effectiveness of the exercise training therapy for the dialysis dependent end-stage renal disease patients and the myokines, which is skeletal muscle derived physiologically active substance
Acronym Exercise training during hemodialysis and myokines
Scientific Title Effectiveness of the exercise training therapy for the dialysis dependent end-stage renal disease patients and the myokines, which is skeletal muscle derived physiologically active substance
Scientific Title:Acronym Exercise training during hemodialysis and myokines
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of the resistance exercise training therapy during hemodialysis on Myokines, Adipo-cytokines, and physical activity and function
Basic objectives2 Others
Basic objectives -Others Change of myokines between pre and post exercise training therapy and the prognostic parameters (all cause mortality and cardiovascular mortality)
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The change of myokines Interleukin-6 (IL-6), Fibroblast growth factor 21 (FGF-21), Follistatin-like1 (FSTL1), Myonectin and adipo-cytokines (adiponectin, omentin) between pre, 6 months, and one year after exercise training therapy
Key secondary outcomes 1.The change of myocardial flow reserve measured by ammonia PET between pre and one year after exercise training therapy
2.The change of Blood biochemistry findings, 12-lead electrocardiogram findings, echocardiography findings, body function evaluation (physical active mass, isometric knee extension muscular strength, muscle mass, exercise tolerance (CPX), Short Physical Performance Battery(SPPB) between pre, 6 month, and one years after exercise training therapy
3.Prognostic parameter after exercise training therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Exercise training
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The patients with maintained hemodialysis (HD) of three times a week for more than three months after HD initiation
Key exclusion criteria 1) Under 20 years old or 90 years or older
2) Need a walking aid and assistance at a walk
3) Needed hospitalizing having acute disease within the past three months
4) Serious heart failure
5) Arrhythmia and the blood pressure abnormality that it is poor in management
6) Severe locomotorium disease including the articular rheumatism
7) Malignant tumor
8) AIDS
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Ohshima
Organization Kaikoukai Healthcare Corporation, Nagoya Kyoritsu Hospital
Division name Department of Cardiology
Zip code 454-0933
Address 1-172, Hokke, Nakagawa-ku, Nagoya, Aichi 454-0933, JAPAN
TEL 052-362-5151
Email kaku@kaikou.or.jp

Public contact
Name of contact person
1st name Yoshifumi
Middle name
Last name Moriyama
Organization Kaikoukai Healthcare Corporation, Nagoya Kyoritsu Hospital
Division name Wellness center
Zip code 454-0933
Address 1-172, Hokke, Nakagawa-ku, Nagoya, Aichi 454-0933, JAPAN
TEL 052-362-5151
Homepage URL
Email ymoriyama@kaikou.or.jp

Sponsor
Institute Kaikoukai Healthcare Corporation
Institute
Department

Funding Source
Organization Kaikoukai Healthcare Corporation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya University Graduate School of medicine
Name of secondary funder(s) International University of Health and Welfare

IRB Contact (For public release)
Organization Kaikoukai Nagoya Kyoritsu Hospital
Address 1-172 Hokke, Nakagawa, Nagoya, Aichi
Tel 052-362-5151
Email msyamada@kaikou.or.jp

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
2020 Year 08 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 21 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047021

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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