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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01451242
Recruitment Status : Unknown
Verified October 2011 by Dr. Ofer Keren, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 13, 2011
Last Update Posted : October 13, 2011
Information provided by (Responsible Party):
Dr. Ofer Keren, Sheba Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Acquired Brain Injury Other: no intervention is made

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Official Title: 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
Study Start Date : October 2011

Group/Cohort Intervention/treatment
brain injury Other: no intervention is made
no intervention is made

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 patients following brain injury hospitalized in sheba medical center in the Brain injury rehabilitation unit.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451242

Contact: Ofer Keren, MD 972-3-5305183
Contact: Michal Katz, PhD

Sheba Medical Center-Brain Injury Rehabilitation Department Not yet recruiting
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Study Chair: Ofer Keren, MD Sheba Medical Center

Responsible Party: Dr. Ofer Keren, MD, Sheba Medical Center Identifier: NCT01451242     History of Changes
Other Study ID Numbers: SHEBA-11-8790-OK-CTIL
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011

Keywords provided by Dr. Ofer Keren, Sheba Medical Center:
Heart Rate Variability
Acquired Brain Injury
Physical Activity

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System