UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041181
Receipt number 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 15:44:07

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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 or person

Institute

Kaikoukai Healthcare Corporation

Institute

Department

Personal name



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

Value
https://center6.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