UMIN-CTR Clinical Trial

Basic information
Public title	Blood pressure regulation during the head-up tilt test in individuals with stroke
Acronym	Blood pressure regulation during the head-up tilt test in individuals with stroke
Scientific Title	Blood pressure regulation during the head-up tilt test in individuals with stroke
Scientific Title:Acronym	Blood pressure regulation during the head-up tilt test in individuals with stroke
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the hemodynamic mechanisms underlying orthostatic blood pressure changes in individuals with stroke.
Basic objectives2	Others
Basic objectives -Others	To assess the cross-sectional and longitudinal associations of orthostatic changes in mean blood pressure with hemodynamic responses to postural change, autonomic nerve function, and body composition.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean blood pressure
Key secondary outcomes	Systolic blood pressure Diastolic blood pressure Heart rate Stroke volume Cardiac output Total peripheral resistance Heart rate variability Baroreflex sensitivity Skeletal muscle mass Total body water Motor function Activities of daily living 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
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Interventions/Control_7
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Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Ischemic or hemorrhagic stroke 2. Stroke within 6 months 3. Scheduled to be hospitalized for 4 weeks or more at the time of study participation 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 2. Unable to understand instructions due to moderate to severe dementia (Mini-Mental State Examination score of less than 20)or aphasia 3. Having implanted metal devices such as a cardiac pacemaker or osteoarticular protheses 4. Unable to maintain a standing position for more than 5 minutes using a tilt table due to severe dizziness or syncope 5. Having a severe respiratory disease 6. Other neurologic conditions in addition to stroke 7. Unable to measure blood pressure from arm due to a fracture of the humerus and/or after surgery for breast cancer 8. Unable to measure blood pressure from fingers 9. Inappropriate patients due to other reasons
Target sample size	80

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	3908621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263372413
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	3908621
Address	3-1-1, Asahi, Matsumoto, Nagano
TEL	0263372413
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
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
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）

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 19 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	Enrolling by invitation
Date of protocol fixation	2022 Year 05 Month 10 Day
Date of IRB	2022 Year 05 Month 12 Day
Anticipated trial start date	2022 Year 05 Month 20 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2027 Year 03 Month 31 Day

Other
Other related information	To examine the cross-sectional and longitudinal associations of orthostatic change in mean blood pressure during the head-up tilt test with hemodynamic responses, autonomic nerve function, and body composition.

Management information
Registered date	2022 Year 05 Month 19 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054381

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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