UMIN-CTR Clinical Trial

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	kikakurinnri@mhlw.go.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	https://www.biorxiv.org/content/10.1101/2020.09.21.305706v2
Publication of results	Published

Result
URL related to results and publications	https://www.biorxiv.org/content/10.1101/2020.09.21.305706v2
Number of participants that the trial has enrolled	45
Results	By mechanical intervention to the head, 1) Blood pressure decreased. 2) LF power in the systolic blood pressure decreased. 3) LF/HF power ratio in the RR interval variability tended to decrease.
Results date posted	2022 Year 11 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Subjects were considered eligible if they were 20 years old or older and confirmed to have 130~160 mm Hg of SBP at the time of interview for informed consent and eligibility check. Subjects with 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) were excluded with the exception of those who were given permission for participating in this study from their primary care physicians
Participant flow	No particular follow-up was conducted after the termination of the study.
Adverse events	None
Outcome measures	Blood pressure, Systolic blood pressure variability, RR interval variability
Plan to share IPD	N/A
IPD sharing Plan description	N/A

Progress
Recruitment status	Main results already published
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	2022 Year 11 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046128