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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Ofer Keren, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01451242
First received: October 10, 2011
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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 Intervention
Acquired Brain Injury
Other: no intervention is made

Study Type: Observational
Study Design: 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

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 30
Study Start Date: October 2011
Groups/Cohorts Assigned Interventions
brain injury Other: no intervention is made
no intervention is made

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451242

Locations
Israel
Sheba Medical Center-Brain Injury Rehabilitation Department
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Ofer Keren, MD Sheba Medical Center
  More Information

Responsible Party: Dr. Ofer Keren, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01451242     History of Changes
Other Study ID Numbers: SHEBA-11-8790-OK-CTIL 
Study First Received: October 10, 2011
Last Updated: October 12, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on December 07, 2016