- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02382926
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
-
-
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
|
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
Collaborators
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
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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