UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033833
Receipt number R000038497
Scientific Title Whether hybrid training during dialysis improve patient's physical function and inflammation and arteriosclerosis
Date of disclosure of the study information 2018/08/29
Last modified on 2018/08/21 12:28:24

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Basic information

Public title

Whether hybrid training during dialysis improve patient's physical function and inflammation and arteriosclerosis

Acronym

Carnitine deficiency is associated with decreased exercise activity in hemodialysis patients

Scientific Title

Whether hybrid training during dialysis improve patient's physical function and inflammation and arteriosclerosis

Scientific Title:Acronym

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

1st name
Middle name
Last name kei Fukami

Organization

Kurume univercity

Division name

nephrology division

Zip code


Address

asahimachi kurumecity fukuokapurifacture

TEL

0942-31-7002

Email

fukami@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Yano

Organization

Kurume University

Division name

Division of Nephrology, Department on Medicine

Zip code


Address

67 Asahi-machi, Kurume-shi, Fukuoka, Japan

TEL

0942-31-7002

Homepage URL


Email

yano_junko@med.kurume-u.ac.jp


Sponsor or person

Institute

Division of Nephrology, Department on Medicine, Kurume University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 29 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

2015 Year 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038497


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name