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

Acquired Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01451242
• Other study ID #: SHEBA-11-8790-OK-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 10, 2011
• Last updated: October 12, 2011
• Start date: October 2011

Study information

• Verified date: October 2011
• Source: Sheba Medical Center
• Contact: Ofer Keren, MD
• Phone: 972-3-5305183
• Email: ofer.keren[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

Intervention

Other:
• no intervention is made
no intervention is made

Locations

Country	Name	City	State
Israel	Sheba Medical Center-Brain Injury Rehabilitation Department	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,