UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047807 |
|---|---|
| Receipt number | 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 19:13:26 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054381
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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