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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Stroke | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shinshu University
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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 |
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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 | |
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 |
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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
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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 |
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Last modified on |
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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 |