Acquired Brain InjuryNCT01451242
The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER
An observational study of Acquired Brain Injury, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acquired Brain Injury
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients following brain injury hospitalized in sheba medical center in the Brain injury rehabilitation unit.
Who may be able to join
- Brain Injury
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Michal Katz, PhD contact
Israel1 site
Sheba Medical Center-Brain Injury Rehabilitation Department
Ramat Gan
About this study
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
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.
- Conditions
- Acquired Brain Injury
- Being tested
- no intervention is made
- Keywords
- Heart Rate Variability, Acquired Brain Injury, Physical Activity
- Medical subject headings
- Brain Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention is madeOther
no intervention is made
| Study group | Role | What they receive |
|---|---|---|
| brain injury | Not described Receives: Other: no intervention is made |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ofer Keren, Sheba Medical Center
- Investigators
- Ofer Keren, MD, Study chair, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451242
- Sponsor's protocol ID
- SHEBA-11-8790-OK-CTIL
- Status last verified
- Oct 2011
- First submitted
- 10 Oct 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01451242
- Acronym / sponsor ID
- SHEBA-11-8790-OK-CTIL
- Conditions
- Acquired Brain Injury
- Keywords
- Heart Rate Variability, Acquired Brain Injury, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2011
- First posted
- 13 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brain injury | – | Other: no intervention is made |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients following brain injury hospitalized in sheba medical center in the Brain injury rehabilitation unit.
Key inclusion criteria (1 listed)
- Brain Injury
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention is madeno intervention is made | Other | brain injury |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Katz, PhD contact
Ofer Keren, MD study chair
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Brain Injury, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofer Keren, MD (972-3-5305183, ofer.keren@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.