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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019746
Receipt No. R000022806
Scientific Title A survey of the effect of exercise training in the change of kidney function for obese CKD patients
Date of disclosure of the study information 2015/11/11
Last modified on 2015/11/25

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Basic information
Public title A survey of the effect of exercise training in the change of kidney function for obese CKD patients
Acronym A survey of the effect of exercise training for obese CKD patients
Scientific Title A survey of the effect of exercise training in the change of kidney function for obese CKD patients
Scientific Title:Acronym A survey of the effect of exercise training for obese CKD patients
Region
Japan

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

Objectives
Narrative objectives1 Obesity is known as a risk factor for CKD. Numerous diseases are associated with obesity, including CKD, CVD, diabetes mellitus, and hypertension. Recently, and especially in the Japanese male, average body mass index (BMI) is increasing with lifestyle changes and a higher calorie diet. In the Japanese national census of 2010, the proportion of obese male subjects had increased approximately 7% compared with the national census of 2000. To prevent CKD progression, it is critical for patients to maintain their appropriate body weight, not only through diet therapy but also exercise training. Several studies have demonstrated the beneficial effects of exercise training on kidney function.
In this study, we will recruit obese CKD patients and assign them to diet/nutrition therapy alone or diet/nutrition therapy with exercise training. We will assess kidney function by using GFR, estimated GFR based on creatinine, and proteinuria both before and after 12 weeks of intervention. We will examine whether the effect of exercise training of obese CKD patients are beneficial to kidney function and proteinuria.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Glomerular Filtration Rate (Inulin Clearance) after 3 months from the biginning of intervention
Key secondary outcomes Serum creatinine based estimated GFR
Proteinuria
Serum albumin level
after 3 months from the biginning of intervention

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
Interventions/Control_1 This study was designed as a 12-week prospective randomized controlled trial. The primary endpoint of this trial was stability of kidney function and proteinuria during exercise training with associated BMI reduction. The secondary endpoints were subject physical status, oxidative stress, and plasma adipokine levels. Subjects for this study were 30- to 75 year-old CKD patients with obesity (BMI >= 25 kg/m).
Subjects were randomly assigned to exercise training and dietary instruction (Group E) or dietary instruction alone (Group D). Both groups had baseline blood and urine samples collected, received inulin, and underwent a para-amino hippuric acid (PAH) clearance test, physical examination, and physical fitness measurement. After a 12-week intervention period, physical and biochemical parameters were again measured, and all parameters were compared before and after intervention.
Dietary instruction will be performed by a registered dietician. All patients will be provided with dietary advice every 4 weeks. The content of the instructions include calorie, protein, and salt adjustments. Specifically, calorie intake is restricted to 25-30 kcal/kgideal body weight (IBW)/day, protein intake was restricted to 0.6-0.8 g/kgIBW/day, and salt is restricted to < 6 g/day.
Interventions/Control_2 Diet and exercise therapy group patients will treat with a program of exercise training under the guidance of fitness trainers. These trainers will instruct the patients on mixed exercise therapy consisting of aerobic exercise using a static bike or walking and weight-bearing muscle training. The goal for the amount of exercise training was > 23 METshour per week. The MET was defined as 3.5 mL/kg/min of oxygen consumption under complete sitting at rest. This goal was provided by an exercise guide designed by the Japanese Ministry of Health, Labour, and Welfare. Before and after intervention, 75% physical working capacity (75%PWC) will be measured.
Dietary instruction will be performed by a registered dietician. All patients will be provided with dietary advice every 4 weeks. The content of the instructions include calorie, protein, and salt adjustments. Specifically, calorie intake is restricted to 25-30 kcal/kgideal body weight (IBW)/day, protein intake was restricted to 0.6-0.8 g/kgIBW/day, and salt is restricted to < 6 g/day.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Obese CKD patients (Body Mass Index>=25)
Key exclusion criteria End Stage Kidney Disease(under renal replacement therapy)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro YAMAGATA
Organization University of Tsukuba
Division name Department of Nephrology, Faculty of Medicine
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL +81-29-853-3210
Email k-yamaga@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirayasu KAI
Organization University of Tsukuba
Division name Department of Nephrology, Faculty of Medicine
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL +81-29-853-3210
Homepage URL
Email hirayasu-kai06@ob.md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 11 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 Completed
Date of protocol fixation
2009 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 03 Month 31 Day
Date of closure to data entry
2010 Year 03 Month 31 Day
Date trial data considered complete
2010 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 11 Day
Last modified on
2015 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022806

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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