NCT01451242

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

First QC Date

October 10, 2011

Last Update Submit

October 12, 2011

Conditions

Keywords

Heart Rate VariabilityAcquired Brain InjuryPhysical Activity

Study Arms (1)

brain injury

Other: no intervention is made

Interventions

no intervention is made

brain injury

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Brain Injury

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center-Brain Injury Rehabilitation Department

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Brain InjuriesMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBehavior

Study Officials

  • Ofer Keren, MD

    Sheba Medical Center

    STUDY CHAIR

Central Study Contacts

Michal Katz, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 13, 2011

Study Start

October 1, 2011

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations