UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Benefit of ergometer exercise during hemodialysis in urine toxin removal efficiency
Title of the study (Brief title)	Benefit of exercise during hemodialysis
Region	Japan

Condition
Condition	Chronic renal failure
Classification by specialty	Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By bicycle ergometer exercise, from a change in the Blood volume and autonomic nervous activity, to elucidate the effect and its mechanism to be given to the solute removal by dialysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the removal rate and removal quantity and clear space in the body urine toxin
Key secondary outcomes	Changes in blood volume Changes in body composition Changes in the blood flow in the capillaries

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Than after the start of dialysis a motion by the ergometer (portable multi-bike 665C), carry out the exercise of 30 minutes.
Interventions/Control_2	Than after dialysis start the movement by the ergometer (portable multi-bike 665C), it is repeated three times rest of the 20 minutes and exercise 10 minutes.
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	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatient maintenance dialysis patients receiving dialysis treatment at the Tokyo Women's Medical University Hospital 20 years of age or older. Carry out dialysis treatment three times a week for 4 hours After blood dialysis for more than three months elapsed (real non-urine) Who consent is obtained to study participants
Key exclusion criteria	Not stable circulatory problems (symptoms of the circulatory system and pronounced than at rest, a person who is determined to require hospital treatment) Blood pressure is 200/100 mmHg or more (before the start of movement) The presence of retinopathy, fundus bleeding during treatment BMI30.0 more The presence of orthopedic, neurological problems that bicycle exercise can not be carried out Active inflammatory disease of, hemorrhagic lesions, autoimmune disease 3 months hospitalized within month Dementia can not be obtained consent
Target sample size	20

Research contact person
Name of lead principal investigator	Akiba_Takashi
Organization	Tokyo Women's Medical University
Division name	Department of Blood Purification
Address	8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL	03-3353-8111
Email	takiba@kc.twmu.ac.jp

Public contact
Name of contact person	Wakayama_Koji
Organization	Tokyo Women's Medical University
Division name	Department of clinical engineering
Address	8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL	03-3353-8111
Homepage URL
Email	wakayama.koji@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	NIPRO CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	東京女子医科大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 26 Day
Anticipated trial start date	2016 Year 03 Month 02 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 06 Month 30 Day

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

Management information
Registered date	2016 Year 02 Month 26 Day
Last modified on	2018 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024472