Heart Cycle GEx (Guided- Exercise- Main Trial) - Full Text View

Purpose

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).

Condition	Intervention
Coronary Artery Disease	Device: Guide Exercise (GEx-)- Training 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

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Guided Exercise (GEx) for CAD Patients

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:

Improvement of physical capacities [ Time Frame: 6 month ] [ Designated as safety issue: No ]
To evaluate whether the GEx- system can improve physical capacities (VO2 peak) at 6 months follow up after cardiac rehabilitation long term phase III home based compared to national standard of cardiac rehabilitation

Secondary Outcome Measures:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Difference in heart rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Level of cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
diastolic function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Basic natriuretic peptide (BNP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
lactate production [ Time Frame: 6 months ] [ Designated as safety issue: No ]
max. Watt load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Borg scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Device Guided Exercise 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 of patients.	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

Arms

Assigned Interventions

Experimental: Device Guided Exercise

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 of patients.

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

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761448

Contacts

Contact: Patrick Schauerte, MD

+492418089669

pschauerte@ukaachen.de

Locations

Germany
Universtiy Hospital of Aachen, Department of Cardiology	Recruiting
Aachen, Northrhine-Westfalia, Germany, 52074
Contact: Patrick Schauerte, MD +4924180 ext 89669 pschauerte@ukaachen.de
Contact: Sigrid Gloeggler, M. Sc. +4924180 ext 80202 sgloeggler@ukaachen.de
Principal Investigator: Patrick Schauerte, Prof. MD
Sub-Investigator: Erik Skobel, MD
Sub-Investigator: Matthias Zink, MD

Sponsors and Collaborators

RWTH Aachen University

University Hospital Madrid, La Paz, Department of Cardiology, Spain

Hull and East Yorkshire Hospitals NHS Trust

Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle

Polytechnical University Valencia, Spain

Medtronic

Centre Suisse d`Electronique et de Microtechnique SA Switzerland

German Sport University, Cologne

More Information

No publications provided

Responsible Party:	RWTH Aachen University
ClinicalTrials.gov Identifier:	NCT01761448 History of Changes
Other Study ID Numbers:	11-020
Study First Received:	July 16, 2012
Last Updated:	January 3, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:

Coronary Artery Disease
Cardiac rehabilitation program
telemedical homely rehabilitation
guided exercise
ECG- vest

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013