UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057409 |
|---|---|
| Receipt number | R000065596 |
| Scientific Title | Effects of Belt-type Electrical Stimulation on Muscle Mass and Physical Function in Elderly Maintenance Hemodialysis Patients: An Exploratory Intervention Study |
| Date of disclosure of the study information | 2025/03/26 |
| Last modified on | 2025/03/26 15:39:00 |
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Basic information
Public title
Effects of Belt-type Skeletal Electrical Stimulation on Muscle Mass and Function in Elderly Maintenance Hemodialysis Patients: A Pilot Study
Acronym
Belt type Skeletal Electrical Stimulation in Hemodialysis
Scientific Title
Effects of Belt-type Electrical Stimulation on Muscle Mass and Physical Function in Elderly Maintenance Hemodialysis Patients: An Exploratory Intervention Study
Scientific Title:Acronym
Belt-type Skeletal Electrical Stimulation in Hemodialysis
Region
| Japan |
Condition
Condition
Elderly Maintenance Hemodialysis Patients
Classification by specialty
| Medicine in general | Nephrology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to explore the safety and potential efficacy of belt-type electrical stimulation (B-SES) in elderly maintenance hemodialysis patients. Specifically, this study aims to evaluate the effects of B-SES on muscle mass, muscle quality, and physical function (including TUG and SPPB), providing foundational data for future large-scale clinical trials.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to evaluate the safety and exploratory efficacy of belt-type electrical stimulation (B-SES) in elderly maintenance hemodialysis patients, specifically assessing whether B-SES can be safely administered and whether it has potential benefits for improving muscle mass and physical function.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Timed Up and Go test will be performed at baseline and after 12 weeks of intervention to assess changes in physical function.
Key secondary outcomes
Change in thigh muscle cross-sectional area measured by CT
Change in intramyocellular lipid content measured by 1H MRS
Change in whole-body muscle mass assessed by bioelectrical impedance analysis BIA
Change in grip strength and calf circumference
Change in inflammatory markers CRP, CK, IL 6 and TNF alfa
Change in quality of life measured by SF 8
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Medical devices,Belt-type electrical stimulation
Interventions/Control_2
Interventions/Control_3
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
End-stage kidney disease patients on hemodialysis ,Minimum 3 months of hemodialysis treatment ,Stable hemodynamics during outpatient maintenance hemodialysis ,Age between 65-90 years ,Daily activity level below 4000 steps ,Voluntary consent to participate,Suspected osteoporosis
Key exclusion criteria
Exclusion Criteria
Sensory impairment,Walking difficulties ,Malignant neoplasms , Severe edema ,Skin conditions preventing electrode attachment,Uncontrolled blood pressure (systolic over 180 mmHg or diastolic over 110 mmHg) ,Concurrent participation in other clinical studies , Acute conditions requiring immediate treatment , Implanted electronic devices ,Temporary pacing or intra-aortic balloon pumping therapy ,Psychiatric disorders or severe dementia ,Other conditions deemed unsuitable by the investigator
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | MISA |
| Middle name | |
| Last name | MIURA |
Organization
Tsukuba University of Technology
Division name
Division of Health Sciences
Zip code
3050825
Address
4-12-7,Kasuga,Ibaraki,305-8521
TEL
0298589552
m.miura@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | MISA |
| Middle name | |
| Last name | MIURA |
Organization
Tsukuba University of Technology
Division name
Division of Heath Sciences
Zip code
305-8521
Address
4-12-7,Kasuga,Ibaraki,305-8521
TEL
0298589552
Homepage URL
m.miura@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
MISA MIURA
Funding Source
Organization
Tsukuba University of Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University of Technology
Address
4-12-7,Kasuga,Ibaraki,305-8521
Tel
0298589552
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
筑波技術大学保健科学部
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
http://hdl.handle.net/10460/00002128
Publication of results
Partially published
Result
URL related to results and publications
http://hdl.handle.net/10460/00002128
Number of participants that the trial has enrolled
8
Results
Belt-type electrical stimulation ,B-SES was safely administered in elderly maintenance hemodialysis patients.
After 12 weeks, significant improvements were observed in TUG and SPPB scores (p<0.05).
CT analysis showed an increase in thigh muscle mass, and 1H-MRS indicated a reduction in intramyocellular lipid ,IMCL.
No significant changes were observed in muscle mass via BIA.
No adverse events occurred during the study.
Results date posted
| 2025 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Mean age 75.5 years
Gender 80 percent male and 20 percent female
Dialysis vintage,Mean 78.0 months
Primary kidney diseases, Diabetic nephropathy 40 percent, chronic glomerulonephritis 40 percent and hypertensive nephrosclerosis 20 percent
BMI 20.5
Long term care level, Equivalent to Level 3,4,5
Daily activity Fewer than 4,000 steps per day
All participants maintained their usual lifestyle without additional exercise guidance during the intervention
Participant flow
Number of enrolled participants: 8
Dropouts: 3 (Reasons: 1 due to hospitalization for infection, 2 due to voluntary withdrawal)
Number of participants completing the intervention: 5 (Completed 12 weeks of intervention)
Adverse events
No adverse events were reported during the study period.
No side effects or negative health impacts were associated with the B-SES therapy.
Outcome measures
Physical Function
Timed Up and Go test
Short Physical Performance Battery
Muscle Mass and Quality Assessment
Thigh muscle cross-sectional area measured by CT
Intramyocellular lipid, IMCL content measured by 1H-MRS
Whole-body Muscle Mass
Bioelectrical Impedance Analysis BIA
Grip Strength and Calf Circumference
Inflammatory Markers
C-reactive protein,CRP
Creatine Kinase, CK
Interleukin-6 , IL-6
Tumor Necrosis Factor-alpha
Quality of Life
SF-8 ,Short Form Health Survey
Plan to share IPD
There is no plan to share individual participant data (IPD).
IPD sharing Plan description
There is no plan to share individual participant data (IPD).
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065596
