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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040420
Receipt No. R000046128
Scientific Title Examination of effects of mechanical stimulation to the brain region responsible for blood pressure control
Date of disclosure of the study information 2021/03/31
Last modified on 2020/05/17

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Basic information
Public title Examination of effects of vertically oscillating chair riding on blood pressure of hypertensive adults
Acronym Examination of effects of vertically oscillating chair riding on blood pressure of hypertensive adults
Scientific Title Examination of effects of mechanical stimulation to the brain region responsible for blood pressure control
Scientific Title:Acronym Examination of effects of mechanical stimulation to the brain region responsible for blood pressure control
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether vertically oscillating chair riding (3 days/week, 4-5 weeks) affects blood pressure of hypertensive humans.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure from pre-intervention to 8 weeks after the termination of the intervention.
Key secondary outcomes Heart rate from pre-intervention to 8 weeks after the termination of the intervention.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Riding a vertically oscillating chair that gives vertical accelerations with peak magnitude of approximately 1.0 x g. Each riding lasts 30 minutes; 3 times (3 days) per week; 4 to 4.5 weeks.
Interventions/Control_2
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 130-160 mm Hg of systolic blood pressure at the time of interview
Key exclusion criteria Mental or psychological illnesses, history or presence of cardiovascular events, history or presence of severe dysfunction/disorder of liver, kidney, lung, gastrointestinal tract, and spine, or presence of acute injuries/diseases (e.g., recent traumas and infectious diseases)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Sawada
Organization National Rehabilitation Center for Persons withDisabilities
Division name Department of Clinical Research
Zip code 359-8555
Address 4-1 Namiki, Tokorozawa, Saitama
TEL 04-2995-3100
Email ys454-ind@umin.ac.jp

Public contact
Name of contact person
1st name Kaoru
Middle name
Last name Sasaki
Organization National Rehabilitation Center for Persons with Disabilities
Division name Department of Planning and Information
Zip code 359-8555
Address 4-1 Namiki, Tokorozawa, Saitama
TEL 04-2995-3100
Homepage URL
Email kikakurinnri@mhlw.go.jp

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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 National Rehabilitation Center for Persons with Disabilities
Address 4-1 Namiki, Tokorozawa, Saitama
Tel 04-2995-3100
Email ys454-ind@umin.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 国立障害者リハビリテーションセンター(埼玉県)

Other administrative information
Date of disclosure of the study information
2021 Year 03 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 05 Month 29 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2021 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
2020 Year 05 Month 17 Day
Last modified on
2020 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046128

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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