Heart Cycle GEx (Guided- Exercise- Main Trial)

NCT01761448 | Completed

• 1 other identifier: 11-020
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

• Difference in heart rate

  6 months

• Blood pressure

  6 months

• Level of cholesterol

  6 months

• weight

  6 months

Study Arms (1)

Device Guided Exercise

EXPERIMENTAL

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; 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

Interventions

Guide Exercise (GEx-)- Training DEVICE

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

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

Device Guided Exercise

Control group training without Guided Exercise system at home DEVICE

Device Guided Exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Hospital Universitario La Paz: collaborator
• Hull University Teaching Hospitals NHS Trust: collaborator
• Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle: collaborator
• Universitat Politècnica de València: collaborator
• Medtronic: collaborator
• Centre Suisse d'Electronique et de Microtechnique SA Switzerland: collaborator
• German Sport University, Cologne: collaborator

Study Sites (1)

Universtiy Hospital of Aachen, Department of Cardiology

Aachen, Northrhine-Westfalia, 52074, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: January 4, 2013
• Study Start: February 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

DE (1)