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Heart Cycle Prestudy

NCT01627457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-11-27

No results posted yet for this study

Summary

In this Prestudy which will be followed by the multicentral GEx- main-trial, the feasibility of a new cardiac rehabilitation device (GEx system) is proved with coronary heart disease patients who participate in cardiac rehabilitation training exercise at the rehabilitation clinic (phase II) and subsequently at home (phase III). The GEx system consists of a easy-to-wear vest with integrated electrodes to measure electrocardiogram (ECG), respiration and activity, furthermore of a PDA to collect and store the monitored data and a cradle to charge the batteries. Several physiological parameters are extracted from thes measured vital signs like heart rate, breathing rate, ECG and activity. In this pretrial first the GEx sensor system is validated during guided exercise of the patients in the rehabilitation clinic (phase II). Subsequently at home (phase III) the practicability of the vest and sensors and possible technical problems in real- life use are proved. This means after moderate training like walking, cycling or running at home for 3 weeks patients will report the feasibility of usage. The ECG data and breathing- frequency data will be analyzed to see if data are recorded and transmitted well in regard to technical problems.

Conditions

Interventions

DEVICE

Guided Exercise (GEx) system

30 CAD patients will wear the GEx system while they are trained during inpatient cardiac rehabilitation (phase II) in order to evaluate accuracy and safety of data like heart rate, breathing, ECG three times a week for about three weeks. In a second step these patients train at home (phase III) in order to evaluate practicability and technical problems of the GEx device three times a week for about three weeks.

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Patrick Schauerte, Professor MD · University Hospital Aachen, Department of Cardiology

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627457 on ClinicalTrials.gov