UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045179 |
|---|---|
| Receipt number | R000051615 |
| Scientific Title | Effects of compression therapy on autonomic function during a head-up tilt test |
| Date of disclosure of the study information | 2021/08/17 |
| Last modified on | 2024/02/18 15:36:18 |
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Basic information
Public title
Effects of compression therapy on autonomic function during a head-up tilt test
Acronym
Effects of compression therapy on autonomic function during a head-up tilt test
Scientific Title
Effects of compression therapy on autonomic function during a head-up tilt test
Scientific Title:Acronym
Effects of compression therapy on autonomic function during a head-up tilt test
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of abdominal and lower extremity compression on heart rate variability during a head-up tilt test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time domain indices of heart rate variability
Key secondary outcomes
Frequency domain indices of heart rate variability, heart rate, blood pressure, subjective symptoms
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 and lower extremity compression during the head-up tilt testing
An abdominal bandage is applied with a pressure of 40 +/- 5 mmHg.
Compression stockings are applied with a pressure of 40 +/- 5 mmHg at the ankle.
Interventions/Control_2
No compression during the head-up tilt testing
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals with no smoking habit
2. Individuals with a minimum calf circumference of between 20 and 21 cm
3. Individuals with an inside leg length of between 70 and 75 cm
4. Individuals who agree to participant 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
40
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
0263-37-2413
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
0263-37-2413
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Physical Therapy, School of Health Sciences, Shinshu University
Institute
Department
Personal name
Funding Source
Organization
A grant from the Funds for Grant-in-Aid for Young Scientists
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
The ethics committee of Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
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
信州大学(長野県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
Results
Lower-body compression significantly decreased the increases in heart rate and Stress Index and the decrease in RMSSD during head-up tilt test. The decrease in upright heart rate by compression was significantly associated with the decrease in upright Stress Index by compression.
Results date posted
| 2023 | Year | 02 | Month | 17 | Day |
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
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Abdominal and lower-extremity compression reduced the orthostatic increase in heart rate (p < 0.001). The tilt-induced changes in heart rate variability parameters, except for the low-frequency component, were smaller in the compression condition than in the no-compression condition (p < 0.001). These results were consistent regardless of sex. Additionally, multiple regression analysis with potentially confounding variables revealed that the compression-induced reduction in Stress Index during the head-up tilt position was a significant independent variable for the compression-induced reduction in heart rate in the head-up tilt position (coefficient = 0.411, p = 0.025).
Management information
Registered date
| 2021 | Year | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051615
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| Registered date | File name |
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