UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of exercise training on kidney function in patients with chronic kidney disease: A prospective multicenter study
Title of the study (Brief title)	CKD-Ex Study
Region	Japan

Condition
Condition	CKD patients
Classification by specialty	Cardiology Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Etimated glomerular filtration rate (eGFR)
Key secondary outcomes	Urine protein, urinary albumin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Intervention group Frequency: Aerobic exercise training more than 3/week (include supervised aerobic exercise training more than 2/week) Time: 30-60min/day Intensity: aerobic threshold (AT) level calculated by cardiopulmonary exercise test Periods: 3months
Interventions/Control_2	Control group Continued usucal daily life with recommended CKD management lifestyle Periods: 3month
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic kidney disease patients(CKD stage: G3a, G3b and G4) and not be applicable to exclusion criteria of exercise training recommended by guideline for Rehabilitation in Patients with Cardiovascular Disease (2012)
Key exclusion criteria	End stage renal failure with hemodialysis therapy, disable patients due to orthopedics or neuromuscular problem, active nephritis, patients with cognitive impairment, patients onset myocardial infarction, stroke, acute heart failure within 1 month or underwent cardiac surgery within 1 month, and keep stable condition at least 1 month, patients have possibility of use EPO during study period.
Target sample size	200

Research contact person
Name of lead principal investigator	Masakazu Saioth
Organization	SAKAKIBARA HEART INSTITUTE HOSPITAL
Division name	Department of Physiotherapy
Address	3-16-1, Asai-cho, Fuchu-shi, Tokyo
TEL	042-314-3111
Email	msaitoh@shi.heart.or.jp

Public contact
Name of contact person	Masakazu Saitoh
Organization	SAKAKIBARA HEART INSTITUTE HOSPITAL
Division name	Department of Physiotherapy
Address	3-16-1, Asai-cho, Fuchu-shi, Tokyo
TEL	042-314-3111
Homepage URL
Email	msaitoh@shi.heart.or.jp

Sponsor
Institute	SAKAKIBARA HEART INSTITUTE HOSPITAL
Institute
Department

Funding Source
Organization	Japan research promotion society for cardiovascular disease
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

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	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 13 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 29 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017768