Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury

Active, not recruiting

• Conditions: Heart Rate Variability; Spinal Cord Injuries; Orthostatic Hypotension

• Registration Number: NCT05982652
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.

Detailed Description

In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-10-13
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-09
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• spinal cord injury with or without OH
• aged 19 or older
• ASIA Impairment Scale (AIS) A to D
• neurological level of injury above T6.

Exclusion Criteria

• Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states
• Those who are taking medications affecting BP that cannot be stopped

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Logistic regression analysis of heart rate variability variables according to OH and presence of symptom	at the test time (15minutes)	the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients.
Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)	at the test time (15minutes)	mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup; 🇰🇷 Yangsan, Gyeongnam, Korea, Republic of