UMIN-CTR Clinical Trial

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