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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016461
Receipt No. R000019114
Scientific Title Effect of eXercise on Proteinuria and Estimated GFR in CKD patients Trial: EXPECT
Date of disclosure of the study information 2015/02/06
Last modified on 2015/02/06

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Basic information
Public title Effect of eXercise on Proteinuria and Estimated GFR in CKD patients Trial: EXPECT
Acronym Exercise Trial in CKD patients
Scientific Title Effect of eXercise on Proteinuria and Estimated GFR in CKD patients Trial: EXPECT
Scientific Title:Acronym Exercise Trial in CKD patients
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of exercise training on proteinuira (albuminuria) and kidney function in patients with CKD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proteinuria,urinary albumin
Key secondary outcomes serum creatine,cystatinC,Etimated glomerular filtration rate (eGFR)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Other
Interventions/Control_1 Intervention group
Frequency: exercise class 1 per week(stretching , balance, resistance, walking, lecture)
recording home exercise everyday (stretching, balance, resistance, walking)
Time: exercise practice for 60 min, lecture for 30 min, home exercise at 3 Mets for 30 min everyday
Periods: 6 months
Interventions/Control_2 Control group
Continued usual daily life
No limitation on exercise
Periods 6 months
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
18 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Chronic kidney disease patients(eGFR 30-60 mL/min/1.73m2 and proteinuria 0.5g/Cr and above) and not be applicable to exclusion criteria of exercise training recommended by guideline for Rehabilitation in Patients with Cardiovascular Disease (2013)
Key exclusion criteria proteinuria(nephrotic level 3g/gCr and more), active retinopathy, disorder of movement with hemiplegia, without consent, without attending doctor's permission
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunari Yasuda
Organization Nagoya University Graduate School of Medicine
Division name Department of CKD Initiatives Internal Medicine, Division of Nephrology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2202
Email yyasuda@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunari Yasuda
Organization Nagoya University Graduate School of Medicine
Division name Department of CKD Initiatives Internal Medicine, Division of Nephrology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2202
Homepage URL
Email yyasuda@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Department of CKD Initiatives Internal Medicine, Division of Nephrology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 02 Month 06 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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 06 Day
Last modified on
2015 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019114

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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