UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048376 |
|---|---|
| Receipt number | R000055138 |
| Scientific Title | Effects of neuromuscular electrical stimulation on bone mineral density in patients undergoing hemodialysis: a randomized controlled trial |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2022/07/14 18:20:03 |
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Basic information
Public title
Effects of neuromuscular electrical stimulation on bone mineral density in patients undergoing hemodialysis: a randomized controlled trial
Acronym
Neuromuscular electrical stimulation in patients undergoing hemodialysis
Scientific Title
Effects of neuromuscular electrical stimulation on bone mineral density in patients undergoing hemodialysis: a randomized controlled trial
Scientific Title:Acronym
Neuromuscular electrical stimulation in patients undergoing hemodialysis
Region
| Japan |
Condition
Condition
Patients undergoing hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of neuromuscular electrical stimulation on bone mineral density in patients undergoing hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The treatment group will be received neuromuscular electrical stimulation in the lower extremities for 6-month, 3 times/week (30 min) during hemodialysis sessions.
Interventions/Control_2
The control group will be received usual care.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing hemodialysis therapy for at least 3-month
2. Patients aged 50 years and older
3. Patients who agree in writing to participate in the study
Key exclusion criteria
1. Patients who underwent leg amputation
2. Patients with a pacemaker or ICD
3. Patients with severe sensory impairments
4. Patients with hemiplegia
5. Patients with untreated bleeding
6. Patients with unstable angina pectoris
7. Patients with an uncontrolled arrhythmia
8. Patients who suffering from hemodynamic instability
9. Patients who started drug therapy for osteoporosis within 1-year prior to participation of the present study
10. Patients who are identified as inadequacy participating into the study for a reason other than above 1.-9. by physician and/or study investigators.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3181
ri-matsuzawa@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3181
Homepage URL
ri-matsuzawa@hyo-med.ac.jp
Sponsor or person
Institute
Department of Physical Therapy School of Rehabilitation, Hyogo Medical University, Kobe, Hyogo, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, the Grant-in-Aid for Young Scientists
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501
Tel
0798-45-6066
rinri@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | 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
| 2022 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2022 | Year | 07 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055138
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
