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
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
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
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
