The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER

October 12, 2011 updated by: Dr. Ofer Keren, Sheba Medical Center

The Reliability of Heart Rate Variability Measurements Among Patients With Acquired Brain Injury as Measured During Physical Activity by POLAR RC810XE Compared to HOLTER EKG

Following a brain injury (BI) in addition to all other systems, there can be a failure in the control of the autonomic system activity. Heart rate (HR) has its own normal variability. Heart rate is controlled by the Sympathetic and Parasympathetic systems. Therefore, monitoring HR variability (HRV) can help us evaluate the balance of the two systems and their efficiency.Decrease in HRV was found to be in correlation with death among patients in the acute stage following ABI. Decrease in HRV is a pre-stage of HR irregularity and ventricular fibrillation.This disturbance can have a great impact on the patients health condition. In addition there was found an inverse correlation between this situation and the rehabilitation outcomes. Based on this data there is a great importance in monitoring HRV during rehabilitation among patients following BI while the patients are required to perform physical activity.The aim of this work is to check whether we can replace the traditional way of measuring HR by EKG Holter (gold standard) with a more simple,accessible tool-the POLAR watch.

The aim of this work is to check if the data collected from a POLAR watch is reliable compared to the data collected from an EKG holter.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center-Brain Injury Rehabilitation Department

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 patients following brain injury hospitalized in sheba medical center in the Brain injury rehabilitation unit.

Description

Inclusion Criteria:

  • Brain Injury

Exclusion Criteria:

  • a medical condition which doesn't allow the patient to participate physical activity.
  • patients that can not be there own legal guardian.
  • uncontrolled psychomotoric restlessness.

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
Intervention / Treatment
brain injury
Other: no intervention is made
no intervention is made

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Study Chair: Ofer Keren, MD, Sheba Medical Center

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

October 1, 2011

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (Estimate)

October 13, 2011

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-11-8790-OK-CTIL

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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