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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047807
Receipt No. R000054381
Scientific Title Blood pressure regulation during the head-up tilt test in individuals with stroke
Date of disclosure of the study information 2022/05/19
Last modified on 2022/05/19

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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
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. 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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