UMIN-CTR Clinical Trial

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

Chronic Kidney Disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

University of Tsukuba

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

筑波大学附属病院（茨城県）

Date of disclosure of the study information

2015

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

11

Month

11

Day

Last modified on

2015

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022806