UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042152 |
|---|---|
| Receipt number | R000048114 |
| Scientific Title | Development of a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2022/10/19 12:20:02 |
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Basic information
Public title
Development of a method for assessing orthostatic hypotension in individuals with stroke
Acronym
Development of a method for assessing orthostatic hypotension in individuals with stroke
Scientific Title
Development of a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table
Scientific Title:Acronym
Development of a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a method for assessing orthostatic hypotension in individuals with stroke without using a tilt table by applying the sit-up test.
Basic objectives2
Others
Basic objectives -Others
1. To examine the relationship and difference of orthostatic changes in blood pressure and hemodynamics between the head up tilt test and the sit-up test.
2. To identify blood pressure cut-offs to diagnose orthostatic hypotension during the sit-up test.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure
Key secondary outcomes
Diastolic blood pressure
Cardiac output
Heart rate
Stroke volume
Total peripheral resistance
Subjective symptoms
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. First-ever stroke
2. Stroke within 1 to 6 months
3. No severe cognitive impairment (a Mini-Mental State Examination score of 24 or more)
4. Consent to participate in this study
Key exclusion criteria
1. Limited range of motion and/or pain that affect the head-up tilt test and the sit-up test
2. Bilateral hemiparetic stroke
3. Mental impairment leading to inability to corporate
4. Unstable medical conditions
5. Other neurologic conditions in addition to stroke
6. Unable to measure blood pressure from the nonparetic arm due to a fracture of the humerus and/or after surgery for breast cancer
7. Inappropriate patients due to other reasons
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, Japan
TEL
+81-263-37-2413
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, Japan
TEL
+81-263-37-2413
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Bay Rehabilitation Hospital
Saku Central Hospital
Kakeyu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Shinshu University
Address
Ethics committee of Shinshu University
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
東京湾岸リハビリテーション病院（千葉県）
佐久総合病院（長野県）
鹿教湯病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | 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
38
Results
During the head-up tilt test, eight and three participants showed systolic and diastolic orthostatic hypotension, respectively.
The receiver operator characteristic curve analyses revealed that the optimal cut-points for orthostatic hypotension using the sit-up test were a decrease of 10 mmHg in systolic blood pressure (area under the curve = 0.915, sensitivity = 87.5%, specificity = 96.7%) and 5 mmHg in diastolic blood pressure (area under the curve = 0.938, sensitivity = 100.0%, specificity = 88.6%).
Results date posted
| 2022 | Year | 04 | Month | 19 | 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 | 09 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | 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
1. To examine the relationship and difference of orthostatic changes in blood pressure and hemodynamics between the head up tilt test and the sit-up test.
2. To identify blood pressure cut-offs to diagnose orthostatic hypotension during the sit-up test.
Management information
Registered date
| 2020 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048114
