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Heart Cycle GEx (Guided- Exercise- Main Trial) (GEx)

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ClinicalTrials.gov Identifier: NCT01761448
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : November 27, 2013
Sponsor:
Collaborators:
Hospital Universitario La Paz
Hull University Teaching Hospitals NHS Trust
Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle
Universitat Politècnica de València
Medtronic
Centre Suisse d'Electronique et de Microtechnique SA Switzerland
German Sport University, Cologne
Information provided by (Responsible Party):
RWTH Aachen University

Tracking Information
First Submitted Date  ICMJE July 16, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date November 27, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Improvement of physical capacities [ Time Frame: 6 month ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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 ]
  • Difference in heart rate [ Time Frame: 6 months ]
  • Blood pressure [ Time Frame: 6 months ]
  • Level of cholesterol [ Time Frame: 6 months ]
  • weight [ Time Frame: 6 months ]
  • Ejection fraction [ Time Frame: 6 months ]
  • diastolic function [ Time Frame: 6 months ]
  • Basic natriuretic peptide (BNP) [ Time Frame: 6 months ]
  • lactate production [ Time Frame: 6 months ]
  • max. Watt load [ Time Frame: 6 months ]
  • Borg scale [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Cycle GEx (Guided- Exercise- Main Trial)
Official Title  ICMJE Guided Exercise (GEx) for CAD Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2013)
37
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
50
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761448
Other Study ID Numbers  ICMJE 11-020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RWTH Aachen University
Study Sponsor  ICMJE RWTH Aachen University
Collaborators  ICMJE
  • Hospital Universitario La Paz
  • Hull University Teaching Hospitals NHS Trust
  • Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle
  • Universitat Politècnica de València
  • Medtronic
  • Centre Suisse d'Electronique et de Microtechnique SA Switzerland
  • German Sport University, Cologne
Investigators  ICMJE Not Provided
PRS Account RWTH Aachen University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP