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

Sponsor

Pusan National University Yangsan Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05982652

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Orthostatic Hypotension Heart Rate Variability

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
non-OH group without orthostaric hypotension in spinal cord injuries
symptomatic OH group Symptomatic individuals in a patient population diagnosed with orthostatic hypotension (Symptom : dizziness, visual disturbance, nausea and headache)
asymptomatic OH group Asymptomatic individuals in a patient population diagnosed with orthostatic hypotension

Outcome Measures

Primary Outcome Measures

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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