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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034149
Receipt No. 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 2018/11/15

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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
Middle name
Last name Yuma Tamura
Organization Dokkyo Medical University Nikko Medical Center
Division name Clinical Research Support Center and Rehabilitation
Zip code
Address 632 Takatoku, Nikko City, Tochigi
TEL 0288-76-1515
Email ytamura@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Niijima
Organization Dokkyo Medical University Nikko Medical Center
Division name Clinical Research Support Center
Zip code
Address 632 Takatoku, Nikko City, Tochigi
TEL 0288-76-1515
Homepage URL
Email aniijima@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Nikko Medical Center
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 14 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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