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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034091
Receipt No. R000038855
Scientific Title The effects of electrical stimulation for lower limbs to maintenance hemodialysis patients with frailty receiving carnitine: A pilot study
Date of disclosure of the study information 2018/10/31
Last modified on 2019/03/13

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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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2019 Year 03 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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