Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs

Study Overview
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Brief Summary
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In this study predictors of fitness to drive a car in cardiologic patients after acute intervention and discharge from hospital to home or rehabilitation are determined in addition to possible automotive monitoring of vital signs via contact less sensors.

Detailed Description
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Increasing numbers of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to fitness of driving after their discharge from hospital to home or rehabilitation. A policy paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience but only little trial data.Therefore predictors of reduced fitness to drive a car are determined via medical data in comparison to data elevated while driving in a simulator and evaluated via Lane Change Test (LCT). Also monitoring of the fitness of driving in the car, automotive monitoring via contactless sensors, could be helpful for judgement.Therefore possible evaluation of heart and breathing rate will be examined with contactless measurements via video camera.

Official Title
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Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients in Rehabilitation and Acute Clinic and Contactless Determination of Vital Signs Via Camera

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation) rehabilitation in clinic An der Rosenquelle Exclusion Criteria: dementia lack of language ability pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiologic Patient<br>Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors | Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors<br>* During a driving simulation medical data are elevated such as electrocardiography (ECG), heart rate breathing rate and oxygen saturation and compared to data of the performed Lane Change Test as a measurement for the quality of driving. Hereby the deviation of the lane from baseline during driving and ordered lane change via signs are determined also when performing cognitive and visual tasks. Also the simulation is simultaneously accompanied by monitoring via contactless camera usage in regard to possible determination of heart and breathing rate according to Eulerian Magnification Method<br>|
| Experimental: Control Proband<br>The same intervention as in arm cardiologic patients :Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors | Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors<br>* During a driving simulation medical data are elevated such as electrocardiography (ECG), heart rate breathing rate and oxygen saturation and compared to data of the performed Lane Change Test as a measurement for the quality of driving. Hereby the deviation of the lane from baseline during driving and ordered lane change via signs are determined also when performing cognitive and visual tasks. Also the simulation is simultaneously accompanied by monitoring via contactless camera usage in regard to possible determination of heart and breathing rate according to Eulerian Magnification Method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiography (ECG) | determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test | 30 minutes | 
| Breathing rate (BR) | determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test | every 5 minutes for 30 minutes | 
| Heart rate (HR) | determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test | every 5 minutes for 30 minutes | 
| Blood pressure | determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test | every 5 minutes for 30 minutes | 
| oxygen saturation | determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test | 30 minutes | 
| mean deviation of baseline lane | determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test | 30 minutes | 
| mean reaction time | determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate (HR) | feasibility of automotive monitoring of heart and breathing rate via contactless camera | every 5 minutes for 30 minutes | 
| Breathing rate | feasibility of automotive monitoring of heart and breathing rate via contactless camera | every 5 minutes for 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocard infarction, arrhythmia, fitness of driving