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

NCT ID: NCT05982652

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries Orthostatic Hypotension Heart Rate Variability

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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non-OH group

without orthostaric hypotension in spinal cord injuries

No interventions assigned to this group

symptomatic OH group

Symptomatic individuals in a patient population diagnosed with orthostatic hypotension (Symptom : dizziness, visual disturbance, nausea and headache)

No interventions assigned to this group

asymptomatic OH group

Asymptomatic individuals in a patient population diagnosed with orthostatic hypotension

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hae-ri Park

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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PARK HAERI, Master

Role: STUDY_DIRECTOR

Pusan National University Yangsan Hospital

Locations

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Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup

Yangsan, Gyeongsangnam-do, South Korea

Site Status

Countries

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South Korea

References

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Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20.

Reference Type BACKGROUND
PMID: 30904574 (View on PubMed)

Other Identifiers

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05-2021-293

Identifier Type: -

Identifier Source: org_study_id

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