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

August 7, 2023 updated by: Hae-ri Park, Pusan National University Yangsan Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongnam
      • Yangsan, Gyeongnam, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals with SCI were recruited from a single university-affiliated rehabilitation hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)
Time Frame: 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
at the test time (15minutes)
Logistic regression analysis of heart rate variability variables according to OH and presence of symptom
Time Frame: 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.
at the test time (15minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Investigators

  • Study Director: PARK HAERI, Master, Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

August 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-2021-293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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