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

NCT ID: NCT01451242

Last Updated: 2011-10-13

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

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acquired Brain Injury

Study Design

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Observational Model Type

COHORT

Study Groups

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brain injury

no intervention is made

Intervention Type OTHER

no intervention is made

Interventions

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no intervention is made

no intervention is made

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Ofer Keren

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ofer Keren, MD

Role: STUDY_CHAIR

Sheba Medical Center

Locations

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Sheba Medical Center-Brain Injury Rehabilitation Department

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ofer Keren, MD

Role: CONTACT

[email protected]
972-3-5305183

Michal Katz, PhD

Role: CONTACT

Other Identifiers

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SHEBA-11-8790-OK-CTIL

Identifier Type: -

Identifier Source: org_study_id