UMIN-CTR Clinical Trial

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
Email	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
Email	k_oyake@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048114