UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061230 |
|---|---|
| Receipt number | R000070052 |
| Scientific Title | Optimal Cut-Points for Orthostatic Hypotension Using a Sit-up Test: A Multicenter Cross-Sectional Study |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/11 00:50:03 |
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Basic information
Public title
Optimal Cut-Points for Orthostatic Hypotension Using a Sit-up Test: A Multicenter Cross-Sectional Study
Acronym
Optimal Cut-Points for Orthostatic Hypotension Using a Sit-up Test: A Multicenter Cross-Sectional Study
Scientific Title
Optimal Cut-Points for Orthostatic Hypotension Using a Sit-up Test: A Multicenter Cross-Sectional Study
Scientific Title:Acronym
Optimal Cut-Points for Orthostatic Hypotension Using a Sit-up Test: A Multicenter Cross-Sectional Study
Region
| Japan |
Condition
Condition
Inpatients receiving rehabilitation treatment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine a cutoff value for identifying the presence or absence of orthostatic hypotension using the sit-up test.
Basic objectives2
Others
Basic objectives -Others
To conduct a subgroup analysis of participants with supine hypertension to evaluate the extent of systolic blood pressure and diastolic blood pressure reduction during the sit-up test in those with orthostatic hypotension during the head-up tilt test.
To examine the associations of blood pressure dysregulation observed during the sit-up test and orthostatic hypotension detected during the head-up tilt test with demographic and clinical characteristics.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure
Key secondary outcomes
Diastolic blood pressure, pulse pressure, Visual Analog Scale score
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged between 65 and 90 years
2. Diagnosed with or having a comorbidity of at least one of the following conditions:
-Neurological disorders (stroke, spinal cord injury, traumatic brain injury, brain or spinal cord tumors, neurodegenerative diseases, demyelinating diseases, peripheral autonomic neuropathy, etc.)
-Cardiac diseases (heart failure, atrial fibrillation, myocardial infarction, etc.)
-Renal failure
-Chronic obstructive pulmonary disease
-Hypertension
-Diabetes mellitus
-Osteoporosis or fragility fractures (fractures due to falls, vertebral compression fractures, etc.)
-Deconditioning
3. At least one week has elapsed since admission, with ongoing physical therapy
4. Possesses the cognitive and language capacity to understand and follow procedural instructions
5. Able to maintain a sitting position either with assistance from one examiner or without manual assistance
Key exclusion criteria
1. Unable to maintain a supine position for more than 5 minutes or a sitting position or upright position on a tilt table for 3 minutes due to joint contracture and pain
2. Known to have difficulty maintaining a standing or sitting position for more than 3 minutes, even with the use of a tilt table, due to severe dizziness or syncope
3. Unable to measure blood pressure in either upper arm due to conditions such as humeral fracture or post-mastectomy status
4. Mobilization restricted per the attending physician's orders
5. Unable to safely perform the sit-up test or tilt test with a single examiner due to factors such as excessive body weight, Pusher syndrome, or severely impaired sitting ability
Target sample size
340
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, School of health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2408
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, School of Health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2408
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu Univeristy
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Life Sciences and Medicine at Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-3099
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
鹿教湯三才山リハビリテーションセンター鹿教湯病院（長野県）、相澤病院（長野県）、伊那中央病院（長野県）、加賀市医療センター（石川県）、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
| 2026 | Year | 04 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood pressure changes will be compared between the sit-up test and the tilt test to determine a cutoff value for detecting orthostatic hypotension using the sit-up test.
A subgroup analysis will be conducted restricted to participants meeting criteria for supine hypertension, assessing the magnitude of systolic and diastolic blood pressure decline during the sit-up test among those classified as having orthostatic hypotension on the tilt test.
We will evaluated Tte associations of orthostatic hypotension, supine hypertension, and seated hypertension detected by the sit-up test as well as orthostatic hypotension detected by the tilt test with demographic and clinical characteristics
Management information
Registered date
| 2026 | Year | 04 | Month | 11 | Day |
Last modified on
| 2026 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070052
