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Clinical Trials/NCT02368158
NCT02368158UnknownNot Applicable

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

RWTH Aachen University4 sites in 1 country40 target enrollmentStarted: October 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
4
Primary Endpoint
Electrocardiography (ECG)

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • lack of language ability
  • pregnancy

Outcomes

Primary Outcomes

Electrocardiography (ECG)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • heart rate (HR)(every 5 minutes for 30 minutes)
  • Breathing rate(every 5 minutes for 30 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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