UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050807 |
|---|---|
| Receipt number | R000057873 |
| Scientific Title | Hemodynamic mechanisms underlying the change in orthostatic systolic blood pressure with compression |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2024/04/10 09:17:40 |
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Basic information
Public title
Effects of compression therapy on orthostatic blood pressure regulation in healthy adults
Acronym
Effects of compression therapy on orthostatic blood pressure regulation in healthy adults
Scientific Title
Hemodynamic mechanisms underlying the change in orthostatic systolic blood pressure with compression
Scientific Title:Acronym
Hemodynamic mechanisms underlying the change in orthostatic systolic blood pressure with compression
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to investigate the hemodynamic mechanisms underlying the change in orthostatic systolic blood pressure with compression. The secondary objective is to investigate significant predictors of the change in orthostatic systolic blood pressure with compression, from the body composition parameters and the hemodynamic and cardiac autonomic responses to head-up tilting without compression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure
Key secondary outcomes
Heart rate, stroke volume, cardiac output, total peripheral resistance, heart rate variability parameters, baroreflex sensitivity, skeletal muscle mass index, hydration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Abdominal compression during the head-up tilt testing: an inflatable abdominal bandage is applied with a pressure of 40+/-5 mmHg -> 10-min washout period -> No compression during the head-up tilt testing
Interventions/Control_2
No compression during the head-up tilt testing -> 10-min washout period -> Abdominal compression during the head-up tilt testing: an inflatable abdominal bandage is applied with a pressure of 40+/-5 mmHg
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals with no smoking habit
2. Individuals who agree to participate in this study
Key exclusion criteria
1. Individuals who have a limited range of motion and/or pain that prevent them to perform a head-up tilt test
2. Individuals who cannot undergo compression therapy due to skin symptoms, such as itching and pain
3. Individuals who are or may be pregnant
4. Individuals who have cardiac and peripheral circulatory diseases
5. Individuals who are taking any autonomic drug such as antihypertensive medications and bronchodilators
6. Individuals who have implanted metal devices
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372413
k_oyake@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263372413
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Kazuaki Oyake
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Nagano
Other related organizations
Co-sponsor
Tokyo Bay Rehabilitation Hospital
Fujita Health University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263372413
mdrinri@shinshu-u.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
東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 10 | 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
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. We explore significant independent variables for the change in orthostatic systolic blood pressure with compression, from heart rate, stroke volume, cardiac output, and total peripheral resistance.
2. We investigate significant predictors of the change in orthostatic systolic blood pressure with compression, from the body composition parameters and the hemodynamic and cardiac autonomic responses to head-up tilting without compression.
Management information
Registered date
| 2023 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057873
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