UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050088 |
|---|---|
| Receipt number | R000057022 |
| Scientific Title | The effect of focal vibration stimulation on thigh muscles using a high-frequency oscillation device on bone mineral density of proximal femur in hemodialysis patients |
| Date of disclosure of the study information | 2023/01/20 |
| Last modified on | 2024/01/21 11:03:34 |
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Basic information
Public title
The effect of focal vibration stimulation on thigh muscles using a high-frequency oscillation device on bone mineral density of proximal femur in hemodialysis patients
Acronym
Vibration stimulation to thigh muscle in hemodialysis patients
Scientific Title
The effect of focal vibration stimulation on thigh muscles using a high-frequency oscillation device on bone mineral density of proximal femur in hemodialysis patients
Scientific Title:Acronym
Vibration stimulation to thigh muscle in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is investigate the effect of focal vibration stimulation using a high-frequency oscillation device to thigh on bone mineral density of proximal femur in hemodialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone mineral density
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
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 focal vibration stimulation using a high-frequency oscillation device will be applied to the hemodialysis patients' right thigh, for 6 months, 3 times/week (10 mins) during hemodialysis sessions.
Interventions/Control_2
As a pseudo-stimulation, something like a towel will be wrapped around the contralateral left side of thigh.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who agree with consent form to participate in the study
2. Patients aged 20 years and older
3. Patients visiting our hospital in order to undergo hemodialysis therapy
Key exclusion criteria
1. Patients with femoral fracture
2. Patients with artificial devices in the femur
3. Patients who have difficulty wearing a high-frequency oscillation device due to physical deformation or skin diseases
4. Women who are pregnant or may become pregnant
5. Patients with poorly controlled deep vein thrombosis
6. Patients with critical limb ischemia
7. Patients who are identified as inadequacy participating into the study for a reason other than above 1.-6. by physician and/or study investigators
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Kobayashi |
Organization
Daido Hospital
Division name
Department of Rehabilitation
Zip code
457-8511
Address
9, Hakusui-cho, Minami-ku, Nagoya, Aichi
TEL
052-611-6265
taka-kobayashi@daidohp.or.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Kobayashi |
Organization
Daido Hospital
Division name
Department of Rehabilitation
Zip code
457-8511
Address
9, Hakusui-cho, Minami-ku, Nagoya, Aichi
TEL
052-611-6265
Homepage URL
taka-kobayashi@daidohp.or.jp
Sponsor or person
Institute
Daido Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Daido Hospital
Address
9, Hakusui-cho, Minami-ku, Nagoya, Aichi
Tel
052-611-6265
taka-kobayashi@daidohp.or.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
| 2023 | Year | 01 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057022
