UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040420 |
|---|---|
| Receipt number | 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 | 2022/11/15 05:15:13 |
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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
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
kikakurinnri@mhlw.go.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046128
