Coronary Artery Disease Clinical Trial
Official title:
Guided Exercise (GEx) for CAD Patients
The object of this study is to determine the improvement obtained in long-term adherence to home-based rehabilitation programs (cardiac rehabilitation phase III) when following a guided exercise training prescription supervised by an innovative system specifically designed to optimize the training effects and maximize the patient´s security compared to the standard care given in each country for this kind of patients. The innovated Guided Exercise- (GEx)- System consists of a sensor that monitors vital parameters during exercise training sessions used in combination with software that provides feedback to the patient based on the training prescription provided by the doctor and the level exertion monitored. This main trial follows a pretrial in which the used ECG sensor was validated at hospital during rehabilitation phase II and the practicability of the vest with this integrated ECG sensor and the possibility of technical problems of this innovative GEx- system were tested in real-life of the patient during phase III at home (ID 11-094).
This is a multicenter study, including 150 patients in three countries comparing data from
standard care given in each country and the data received by using the new GEx- system. In
Germany during the rehabilitation process of Coronary Artery Disease (CAD) patients in
hospital (phase II, about three weeks)50 patients are recruited, including 25 using the
innovative System and 25 in a control group not using the new Guided Exercise System).
Patients of the interventional group are made familiar with the Guided Exercise System
during exercise training in hospital (phase II).
This Guided Exercise (GEx-)- System consists of a easy to wear- vest with integrated
electrodes to measure ECG, respiration and activity, furthermore of a PDA mobile phone with
a touch screen for interaction with the patient and a patient station as interface between
the personal digital assistant(PDA) and the professional station able to synchronize
exercise plans prescribed by professionals and extract the monitored data from the PDA and
upload it to the professional system using an internet connection.
Both intervention and control group undergo a baseline evaluation and an end evaluation
including tests of the clinical routine like cardiopulmonary test (CPX), echocardiography
and lactate measurement. They will also answer questionnaires referring to quality of life
and the use of the system. During the training phase at home the interventional group will
test the supervised training system during endurance training such as running, biking or
walking and during resistance training such as performing exercise with rubber bands (at
least 3x a week for about 5 months according to the generated prescription plan during
training at the hospital). They will report their daily activity by diary. The control group
will only report their physical activities by diary without using the Gex- System. At the
end data are investigated to determine the feasibility to determine possible improvement
obtained in long-term adherence to home- based rehabilitation programs when following a
guided exercise training prescription supervised by the GEx- System.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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