UMIN-CTR Clinical Trial

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
Email	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
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	Dokkyo Medical University Nikko Medical Center IRB
Address	632 Takatoku, Nikko City, Tochigi
Tel	0288-76-1515
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037567