Clinical trial NCT01761448: Heart Cycle GEx (Guided- Exercise- Main Trial)
Official title: Guided Exercise (GEx) for CAD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Cardiac rehabilitation program
telemedical homely rehabilitation
guided exercise
ECG- vest
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
name: Hull University Teaching Hospitals NHS Trust
name: Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle
name: Universitat Politècnica de València
name: Medtronic
name: Centre Suisse d'Electronique et de Microtechnique SA Switzerland
name: German Sport University, Cologne
First posted: 2013-01-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* patients suffering from CAD and presenting after an acute myocardial infarction or elective coronary intervention
* EF \> 30%
* patients willing to exercise
* with a preference for walking / running / cycling
* patients eligible for the normal local rehabilitation programs
* ability to use computer and internet
* adults who are contractually capable and mentally able to understand and follow the instructions of study personnel
* signed informed consent

Exclusion Criteria:

* Severe congestive heart failure New York Heart Association (NYHA) III/IV
* slow healing wounds
* pregnancy and breast feeding

Primary outcomes:
measure: Improvement of physical capacities
timeFrame: 6 month
Secondary outcomes:
measure: Differences in heart rate, blood pressure, level of cholesterol, weight, ejection fraction (EF), diastolic function, basic natriuretic peptide (BNP), Lactate production and maximal Watt load, Borg scale
timeFrame: 6 months
measure: Difference in heart rate
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Level of cholesterol
timeFrame: 6 months
measure: weight
timeFrame: 6 months
measure: Ejection fraction
timeFrame: 6 months
measure: diastolic function
timeFrame: 6 months
measure: Basic natriuretic peptide (BNP)
timeFrame: 6 months
measure: lactate production
timeFrame: 6 months
measure: max. Watt load
timeFrame: 6 months
measure: Borg scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universtiy Hospital of Aachen, Department of Cardiology
state: Northrhine-Westfalia
Study officials:
References: