Heart Cycle GEx (Guided- Exercise- Main Trial)

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).

Conditions

• Coronary Artery Disease

Interventions

DEVICE

Guide Exercise (GEx-)- Training

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.

DEVICE

Guided Exercise Training with an easy to wear vest with electrodes to measure ECG, respiration, activity

DEVICE

Control group training without Guided Exercise system at home

Sponsors & Collaborators

• Hospital Universitario La Paz

  collaborator OTHER

• Hull University Teaching Hospitals NHS Trust

  collaborator OTHER_GOV

• Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle

  collaborator UNKNOWN

• Universitat Politècnica de València

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Centre Suisse d'Electronique et de Microtechnique SA Switzerland

  collaborator UNKNOWN

• German Sport University, Cologne

  collaborator OTHER

• RWTH Aachen University

  lead OTHER

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• Germany

Study Locations