UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034149 |
|---|---|
| Receipt number | R000037567 |
| Scientific Title | Effect of skeletal muscle electrical stimulation on blood pressure and vascular endothelial function in hypertensive patients |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2021/09/16 14:59:51 |
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Basic information
Public title
Effect of skeletal muscle electrical stimulation on blood pressure and vascular endothelial function in hypertensive patients
Acronym
Hypotensive effect by the skeletal muscle electrical stimulation
Scientific Title
Effect of skeletal muscle electrical stimulation on blood pressure and vascular endothelial function in hypertensive patients
Scientific Title:Acronym
Hypotensive effect by the skeletal muscle electrical stimulation
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the hypotensive effect and vascular endothelial function by skeletal muscle electrical stimulation for hypertension patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure(change from baseline with the six weeks electrotherapy).
Key secondary outcomes
Knee extension muscular strength, quantity and quality of muscle, exercise tolerability, vascular endothelial function, autonomic nervous function(Baseline and after 6 weeks)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects visit rehabilitation twice a week, both lower limbs perform belt type skeletal muscle electrical stimulation for 20 minutes. Intensity is NRS 7 or more. Intervention period is 3 months.
Interventions/Control_2
Subjects visit rehabilitation twice a week, both lower limbs perform belt type skeletal muscle electrical stimulation for 20 minutes. Intensity is NRS 3 or less. Intervention period is 3 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatient or volunteer with hypertension (More than systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg)
Key exclusion criteria
1,Change of medication during the examination.
2,Can not receive hospital based rehabilitation once a week for 3 months
3,Patient of body device implanted (eg pacemaker, CRT)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuma |
| Middle name | |
| Last name | Tamura |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Clinical Research Support Center and Rehabilitation
Zip code
321-2593
Address
632 Takatoku, Nikko City, Tochigi
TEL
0288-76-1515
ytamura@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Niijima |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Clinical Research Support Center
Zip code
321-2593
Address
632 Takatoku, Nikko City, Tochigi
TEL
0288-76-1515
Homepage URL
aniijima@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
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
Dokkyo Medical University Nikko Medical Center IRB
Address
632 Takatoku, Nikko City, Tochigi
Tel
0288-76-1515
rinshokenkyu@dokkyomed.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
獨協医科大学日光医療センター（栃木県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 18 | 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 | 06 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2021 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037567
| 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 |
