UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059401 |
|---|---|
| Receipt number | R000067919 |
| Scientific Title | Nonpharmacologic management of orthostatic hypotension based on hemodynamic profiles |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/14 21:18:59 |
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Basic information
Public title
Hemodynamic-guided nonpharmacologic management of orthostatic hypotension
Acronym
Hemodynamic-guided nonpharmacologic management of orthostatic hypotension
Scientific Title
Nonpharmacologic management of orthostatic hypotension based on hemodynamic profiles
Scientific Title:Acronym
Nonpharmacologic management of orthostatic hypotension based on hemodynamic profiles
Region
| Japan |
Condition
Condition
High-risk conditions for orthostatic hypotension: neurological disorders, cardiovascular diseases, kidney failure, COPD, hypertension, diabetes mellitus, fragility fractures, and deconditioning.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether the efficacy of lower abdominal compression for orthostatic hypotension differs based on its hemodynamic phenotypes.
Basic objectives2
Others
Basic objectives -Others
1. To compare participant characteristics and hemodynamic variables during head-up tilt testing between participants with and without orthostatic hypotension in the control condition.
2. To compare participant characteristics and the prevalence of orthostatic hypotension according to different patterns of orthostatic changes in cardiac output and total peripheral resistance in the control condition.
3. To compare orthostatic changes in blood pressure and hemodynamic variables with and without abdominal compression. A subgroup analysis limited to participants with orthostatic hypotension will be performed.
4. To investigate whether the ameliorating effect of abdominal compression on orthostatic blood pressure reduction is associated with hemodynamic response patterns during standing in the control condition.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Systolic blood pressure
Key secondary outcomes
Diastolic blood pressure
Mean arterial pressure
Heart rate
Stroke volume index
Cardiac index
Total peripheral resistance index
Visual analogue scale score
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Abdominal compression during the head-up tilt testing: an inflatable abdominal bandage is applied with a pressure of 40+/-5 mmHg -> 10-min washout period -> No compression during the head-up tilt testing
Interventions/Control_2
No compression during the head-up tilt testing -> 10-min washout period -> Abdominal compression during the head-up tilt testing: an inflatable abdominal bandage is applied with a pressure of 40+/-5 mmHg
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. Age between 65 and 90 years
2. Having one or more of the following diseases as a primary diagnosis or comorbidity:
Neurological disorders (stroke, spinal cord injury, head trauma, brain/spinal cord tumor, neurodegenerative diseases, demyelinating diseases, peripheral autonomic neuropathy, etc.)
Cardiovascular diseases (heart failure, atrial fibrillation, myocardial infarction, etc.)
Kidney failure
COPD
Hypertension
Diabetes mellitus
Fragility fractures
Deconditioning
3. At least one week has elapsed since hospital admission
4. Expected hospital stay of at least four weeks
5. Sufficient cognitive and language function to understand instructions for the experimental procedures
6. Able to provide written informed consent from the participant or a legally authorized representative for participation in this study
Key exclusion criteria
1. Unable to perform a head-up tilt test due to joint contractures, pain, or other physical limitations
2. Currently undergoing or scheduled to begin treatment for osteoporosis
3. Presence of abdominal aortic aneurysm detected on abdominal screening at admission, history of thoracoabdominal surgery within the past 2 months, tube feeding, or gastrostomy
4. Presence of cardiac pacemaker, prosthetic joint, or other metallic implants
5. Unable to maintain standing position for at least 3 minutes even with a tilt table due to severe dizziness or syncope
6. Unable to measure blood pressure on the upper arm due to humeral fracture, post-mastectomy status, or other reasons
7. Unable to undergo abdominal compression due to skin injury, itching, or discomfort around the pelvic area
8. Restricted from mobilization or exercise per attending physician's order
9. Any other condition deemed inappropriate for study participation by the attending physician or principal investigator
Target sample size
75
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
390-8621
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
390-8621
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
Kazuaki Oyake
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Bay Rehabilitation Hospital
Fujita Health University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263372413
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
| 2025 | Year | 10 | Month | 15 | 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
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. To compare participant characteristics and hemodynamic variables during head-up tilt testing between participants with and without orthostatic hypotension in the control condition.
2. To compare participant characteristics and the prevalence of orthostatic hypotension according to different patterns of orthostatic changes in cardiac output and total peripheral resistance in the control condition.
3. To compare orthostatic changes in blood pressure and hemodynamic variables with and without abdominal compression. A subgroup analysis limited to participants with orthostatic hypotension will be performed.
4. To investigate whether the ameliorating effect of abdominal compression on orthostatic blood pressure reduction is associated with hemodynamic response patterns during standing in the control condition.
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067919
