Heart Cycle GEx (Guided- Exercise- Main Trial)

Coronary Artery Disease Clinical Trial

— GEx  

Official title:

Guided Exercise (GEx) for CAD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761448
• Other study ID #: 11-020
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: November 26, 2013
• Start date: February 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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

Locations

Country	Name	City	State
Germany	Universtiy Hospital of Aachen, Department of Cardiology	Aachen	Northrhine-Westfalia

Sponsors (8)

Lead Sponsor	Collaborator
RWTH Aachen University	Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle, Centre Suisse d'Electronique et Microtechnique SA, German Sport University, Cologne, Hospital Universitario La Paz, Hull and East Yorkshire Hospitals NHS Trust, Medtronic, Universidad Politécnica de Valencia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of physical capacities	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	6 month	No
Secondary	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		6 months	No
Secondary	Difference in heart rate		6 months	No
Secondary	Blood pressure		6 months	No
Secondary	Level of cholesterol		6 months	No
Secondary	weight		6 months	No
Secondary	Ejection fraction		6 months	No
Secondary	diastolic function		6 months	No
Secondary	Basic natriuretic peptide (BNP)		6 months	No
Secondary	lactate production		6 months	No
Secondary	max. Watt load		6 months	No
Secondary	Borg scale		6 months	No