Tokyo, April 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061230) titled 'Optimal Cut-Points for Orthostatic Hypotension Using a Sit-up Test: A Multicenter Cross-Sectional Study' on April 13.
Study Type:
Observational
Primary Sponsor:
Institute - Shinshu Univeristy
Condition:
Condition - Inpatients receiving rehabilitation treatment
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 65
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 Size - 340
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070052
Disclaimer: Curated by HT Syndication.