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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039589
Receipt No. R000045147
Scientific Title Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Date of disclosure of the study information 2020/02/25
Last modified on 2021/02/25

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Basic information
Public title Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Acronym Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Scientific Title Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Scientific Title:Acronym Effect of exercise therapy on residual renal function in incident peritoneal dialysis patients
Region
Japan

Condition
Condition Chronic Kidney Disease Stage5-D
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will enroll patients initial incident PD to investigate how exercise therapy
affects residual function in the induction phase of PD.
Basic objectives2 Others
Basic objectives -Others functional mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes residual renal function, rGFR (the mean of Urea and Creatinine clearances)
Key secondary outcomes L-FABP, KIM-1, NGAL, Cystatin C, NAG, beta2 MG,micro albumin to creatinine ratio
Serum Na/K/Cl,Ca/P/PTH intact,UA, TC/HDL/TG,Hb,HbA1c,FOMA-IR,QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 determineed exercise tolerance and optimum home-based exercise therapy. 3times/week
Interventions/Control_2 non-intervention-controlled
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
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The incident peritonearl dyalisis patients and suit the conditions as below.
1) 30yeas old or more, under 90years old
2) Patients who have been fully informed about participating in this study, have a thorough understanding, and have given their informed consent
Key exclusion criteria Patients who are contraindicated for exercise therapy (specifically the following)
1. Uncontrolled hypertension (>180 systolic blood pressure or >110 mmHg diastolic blood pressure persistent)
2. Severe anemia (Hb under 7 g/dL)
3. Active proliferative diabetic retinopathy
4. Patients with coronary artery disease or cerebrovascular disease within 3 months
5. Uncontrolled heart failure (NYHA III or higher)
6. People who have difficulty walking
7. Others who are not investigators or those who are inappropriate as study subjects
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Seiki
Middle name
Last name Yamada
Organization International University of Health and Welfare Graduate School of Medicine
Division name Department of medicine, Clinical research of medicine
Zip code 107-8402
Address 4-1-26, Akasaka, Minato-ku, Tokyo
TEL 03-5574-3900
Email yseiki4223@gmail.com

Public contact
Name of contact person
1st name Seiki
Middle name
Last name Yamada
Organization International University of Health and Welfare Graduate School of Medicine
Division name Department of medicine, Clinical research of medicine
Zip code 107-8402
Address 4-1-26, Akasaka, Minato-ku, Tokyo
TEL 03-5574-3900
Homepage URL
Email yseiki4223@gmail.com

Sponsor
Institute International University of Health and Welfare Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Faculty of medicine, Keio University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethcal Committee of Faculty of medicine, International University of Health and Welfare University
Address 4-3 Kouzunomori, Narita city, CHiba Pref.
Tel 0476-20-7703
Email rinri_md@iuhw.ac.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 国際医療福祉大学熱海病院、国際医療福祉大学病院、国際医療福祉大学成田病院、慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 25 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 Enrolling by invitation
Date of protocol fixation
2020 Year 02 Month 14 Day
Date of IRB
2020 Year 02 Month 13 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2025 Year 03 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 02 Month 25 Day
Last modified on
2021 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045147

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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