Heart Cycle GEx (Guided- Exercise- Main Trial)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Guide Exercise (GEx-)- Training; Guided Exercise Training with an easy to wear vest with electrodes to measure ECG, respiration, activity; Control group training without Guided Exercise system at home
Intervention type(s): Device; Device; Device
Intervention description(s): 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 5-6 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 whether the supervised training with the GEx- System will improve the physical capacities ( VO2 peak) of patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Coronary Artery Disease; Cardiac rehabilitation program; telemedical homely rehabilitation; guided exercise; ECG- vest