UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039179 |
|---|---|
| Receipt number | R000044682 |
| Scientific Title | Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2021/07/18 11:40:06 |
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Basic information
Public title
Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Acronym
Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Scientific Title
Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Scientific Title:Acronym
Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the concurrent validity of a Sit-up test against a head-up tilt test for assessing the orthostatic changes in blood pressure and hemodynamics in healthy adults.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine the concurrent validity of a Sit-up test against a head-up tilt test for assessing the orthostatic changes in blood pressure and hemodynamics in healthy adults. This study may contribute to establishing the assessment method of orthostatic hypotension that is available with or without a tilt bed and regardless of standing ability.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure
Key secondary outcomes
Diastolic blood pressure
Mean arterial pressure
Heart rate
Stroke volume
Cardiac output
Heart rate variability
Baroreflex sensitivity
Symptoms of orthostatic hypotension
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Able to perform activities of daily living independently
2.Consent to participate in this study
Key exclusion criteria
1.Limited range of motion and/or pain that affect the sit-up and head-up tilt tests
2.Neurologic conditions and/or spinal cord injury
3.Uncontrolled hypertension and/or diabetes mellitus
4.Inappropriate patients due to other reasons
Target sample size
20
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@shunshu-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@shunshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Bay Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
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）
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
| 2020 | Year | 03 | Month | 31 | 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
18
Results
There were significant correlations between the tests for orthostatic changes in systolic blood pressure, diastolic blood pressure, and heart rate.
Compared to the head-up tilt test, the sit-up test showed the smaller decrease in systolic blood pressure, the larger increase in diastolic blood pressure, and the smaller increase in heart rate during testing.
Results date posted
| 2021 | Year | 01 | Month | 16 | 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
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine the correlations and the differences of the orthostatic changes in hemodynamics between the head-up tilt test and the sit-up test.
Management information
Registered date
| 2020 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044682
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| Registered date | File name |
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| Registered date | File name |
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