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

Not Applicable

• Conditions: Cardiovascular Diseases
• Interventions: Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors

• Registration Number: NCT02368158
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-20
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-15
• Last Update Posted: 2015-09-16
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiologic Patient	Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors	Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors
Control Proband	Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors	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

Primary Outcome Measures

Name	Time	Method
Electrocardiography (ECG)	30 minutes	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
Breathing rate (BR)	every 5 minutes for 30 minutes	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
Heart rate (HR)	every 5 minutes for 30 minutes	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
Blood pressure	every 5 minutes for 30 minutes	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
oxygen saturation	30 minutes	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
mean deviation of baseline lane	30 minutes	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
mean reaction time	30 minutes	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

Secondary Outcome Measures

Name	Time	Method
heart rate (HR)	every 5 minutes for 30 minutes	feasibility of automotive monitoring of heart and breathing rate via contactless camera
Breathing rate	every 5 minutes for 30 minutes	feasibility of automotive monitoring of heart and breathing rate via contactless camera

Trial Locations

Locations (2)

Clinic of Rehabilitation "An der Rosenquelle"; 🇩🇪 Aachen, North Rhine Westphalia, Germany

Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen; 🇩🇪 Aachen, North Rhine Westphalia, Germany