UMIN-CTR Clinical Trial

Basic information
Public title	The effects of electrical stimulation for lower limbs to maintenance hemodialysis patients with frailty receiving carnitine: A pilot study
Acronym	The effects of electrical stimulation for hemodialysis patients receiving carnitine
Scientific Title	The effects of electrical stimulation for lower limbs to maintenance hemodialysis patients with frailty receiving carnitine: A pilot study
Scientific Title:Acronym	The effects of electrical stimulation for hemodialysis patients receiving carnitine
Region	Japan

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

Objectives
Narrative objectives1	We will investigate carnitine and electrical stimulation therapy of the lower extremities to maintenance dialysis patients and subsequently examine and compare capacity of for physical activity such as muscle strength, circulatory function, anemia, as well as the effectiveness of these treatments in preventing incidents such as fall events.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Physical activity
Key secondary outcomes	biochemical effects

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	We administer to the patients levocarnitine 1000 mg/dose during every dialysis for 3 months and compare with the sedentary group.
Interventions/Control_2	We administer to the patients levocarnitine 1000 mg/dose during every dialysis for 3 months and compare with the levocarnitin + electrical stimulation group.
Interventions/Control_3	Sedentary group that underwent standard hemodialysis treatment without any specific therapy.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Disease stage is Stage 5 CKD. 2. Physical status is long-term care level 3 or higher (even if prior to official receipt of care level certification). 3. Patients who have provided their informed written consent to participation in the study.
Key exclusion criteria	1. Patients presenting with unstable angina, acute phase acute coronary syndrome, hemodynamic instability, or resting SpO2 lower than 90. 2. Patients exhibiting a marked decline in cognitive functions, patients wearing pacemaker devices, or pregnant women. 3. Other patients deemed by a physician to be otherwise unsuitable for participation in this study.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Misa Middle name Last name Miura
Organization	Tsukuba University of technology
Division name	Faculty of Health Sciences
Zip code	305-8521
Address	Kasuga 4-12-7, Tsukuba City, Ibaraki
TEL	029-858-9552
Email	m.miura@k.tsukuba-tech.ac.jp

Public contact
Name of contact person	1st name Aki Middle name Last name Hirayama
Organization	Tsukuba University of technology
Division name	Faculty of Health Sciences
Zip code	305-8521
Address	Kasuga 4-12-7, Tsukuba City, Ibaraki 305-8521
TEL	029-858-9552
Homepage URL
Email	aki-hira@k.tsukuba-tech.ac.jp

Sponsor
Institute	Tsukuba University of technology
Institute
Department

Funding Source
Organization	Tsukuba University of technology
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Tsukuba University of Technology
Address	4-12-7 Kasuga, Tsukuba City, Ibaraki prefecture, Japan
Tel	029-858-9552
Email	m.miura@k.tsukuba-tech.ac.jp

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	平山病院

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 31 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	2018 Year 11 Month 01 Day
Date of IRB	2018 Year 09 Month 19 Day
Anticipated trial start date	2018 Year 11 Month 05 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 01 Month 31 Day
Date trial data considered complete	2022 Year 01 Month 31 Day
Date analysis concluded	2022 Year 03 Month 10 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 11 Day
Last modified on	2022 Year 03 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038855