Reha Drive: Capacitive Electrocardiography in Car Seat in Cardiological Patients (RehaDrivecECG)

March 12, 2015 updated by: RWTH Aachen University

Capacitive Electrocardiography in the Driver's Seat and Elevation of Vital Signs Via Camera During Cardiac Rehabilitation

In this trial contactless heart rate, electrocardiography and breathing rate measurements are elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Increasing number of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to their fitness of driving during cardiac rehabilitation. Little trial data are known, only a position paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience. For judgement and recommendations automotive monitoring via contactless sensors might be helpful. Therefore while "driving" in a simulator distinct heart circulation situations will be created. Vital signs will be measured via long term electrocardiography (ECG) in comparison to contactless capacitive ECG (cECG) measurements via embedded sensors in the car seat as well as heart rate and breathing rate measurements via camera.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine Westphalia
      • Aachen, North Rhine Westphalia, Germany, 52064
        • Clinic of Rehabilitation "An der Rosenquelle", Kurbrunnenstreet 5
      • Aachen, North Rhine Westphalia, Germany, 52074
        • University Hospital Aachen, Department of Cardiology, Angiology, Pneumology and Intensive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cardiologic diseases after acute event (e. g. myocard infarction, bypass surgery)
  • rehabilitation in clinic "An der Rosenquelle"

Exclusion Criteria:

  • dementia
  • lack of language ability
  • pregnancy
  • implanted electric devices (as e.g. heart pacemaker, inverted cardiodefibrillator)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: contactless heart-, breathing rate, ECG
Other: Capacitive ECG and contactless heart and breathing rate measurements via camera
During a 30 minute driving simulation cardiologic patients in rehabilitation undergo capacitive ECG measurements via sensors in the car seat as well as heart and breathing rate measurements via camera according to the Eulerian Magnification Method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arrhythmia
Time Frame: 30 minutes
feasibility of cECG data for example as arrhythmia, tachycardia in comparison to long term ECG data
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate via contactless camera
Time Frame: 30 minutes
feasibility of heart rate measurements according to the Eulerian Magnification Method in comparison to standard measurement data
30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breathing rate via contactless camera
Time Frame: 30 minutes
feasibility of breathing rate measurements according to the Eulerian Magnification Method in comparison to standard measurement data
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

RWTH Aachen Institute of Medical Information Technology

Investigators

  • Principal Investigator: Sebastian Reith, MD, University Hospital Aachen, Clinic of Cardiology, Angiology, Pneumology and Intensive Care Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTC-A 14-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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