Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059401) titled 'Hemodynamic-guided nonpharmacologic management of orthostatic hypotension' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Shinshu University
Condition:
Condition - High-risk conditions for orthostatic hypotension: neurological disorders, cardiovascular diseases, kidney failure, COPD, hypertension, diabetes mellitus, fragility fractures, and deconditioning.
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 65
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 Size - 75
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067919
Disclaimer: Curated by HT Syndication.
