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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05982652

Enrollment

Registered

2023-08-08

Start date

2022-01-01

Completion date

2023-12-31

Last updated

2023-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate Variability, Orthostatic Hypotension, Spinal Cord Injuries

Keywords

Spinal Cord Injuries, Orthostatic Hypotension, Heart rate variability, Autonomic nervous system

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results