UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034091 |
|---|---|
| Receipt number | 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 | 2022/03/15 11:10:10 |
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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
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
aki-hira@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038855
