UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Whether hybrid training during dialysis improve patient's physical function and inflammation and arteriosclerosis
Title of the study (Brief title)	Carnitine deficiency is associated with decreased exercise activity in hemodialysis patients
Region	Japan

Condition
Condition	hemodyalysis people
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Carnitine deficiency is common in hemodialysis patients and is associated with muscle atrophy in hemodialysis patients. Here we investigated whether carnitine levels could be one of the independent predictor for exercise capacity in these patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exercise tolerance test
Key secondary outcomes	Before exercise and after 3 months Grip strength time up Go test Lower limb muscle strength functional reach test Body composition measurement Thigh muscle area by MRI etc

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We administer to the patient levocarnitine 1000 mg/dose during every dialysis for 3 months and compare with the placebo group.
Interventions/Control_2	We administer to the patient levocarnitine 1000 mg/dose during every dialysis for 3 months and compare it with the exercise group.
Interventions/Control_3	We administer to the patient levocarnitine 1000 mg/dose during every dialysis for 3 months and compare with the hybrid exercise group.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients over the age of 20 years with end stage renal disease undergoing hemodialysis 2.Patients able to provide written informed consent for study participation
Key exclusion criteria	1.Patients under the age of 20 years old 2.Patients who are contraindicated in the package insert of Levocarnitine 3.Patients undergoing combination therapy with peritoneal dialysis and hemodialysis 4.Pregnant woman, or a woman who have possibility of pregnancy 5.Others not inadequate judged by a physician 6.Patients who do not obtain consent
Target sample size	40

Research contact person
Name of lead principal investigator	kei Fukami
Organization	Kurume univercity
Division name	nephrology division
Address	asahimachi kurumecity fukuokapurifacture
TEL	0942-31-7002
Email	fukami@med.kurume-u.ac.jp

Public contact
Name of contact person	Junko Yano
Organization	Kurume University
Division name	Division of Nephrology, Department on Medicine
Address	67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL	0942-31-7002
Homepage URL
Email	yano_junko@med.kurume-u.ac.jp

Sponsor
Institute	Division of Nephrology, Department on Medicine, Kurume University
Institute
Department

Funding Source
Organization	Division of Nephrology, Department on Medicine, Kurume University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2018 Year 08 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2018 Year 04 Month 01 Day
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	2018 Year 08 Month 21 Day
Last modified on	2018 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038497