- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01761448
Heart Cycle GEx (Guided- Exercise- Main Trial) (GEx)
Guided Exercise (GEx) for CAD Patients
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Northrhine-Westfalia
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Aachen, Northrhine-Westfalia, Germany, 52074
- Universtiy Hospital of Aachen, Department of Cardiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: 6 months
|
6 months
|
diastolic function
Time Frame: 6 months
|
6 months
|
Ejection fraction
Time Frame: 6 months
|
6 months
|
Borg scale
Time Frame: 6 months
|
6 months
|
weight
Time Frame: 6 months
|
6 months
|
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
|
6 months
|
Difference in heart rate
Time Frame: 6 months
|
6 months
|
Level of cholesterol
Time Frame: 6 months
|
6 months
|
Basic natriuretic peptide (BNP)
Time Frame: 6 months
|
6 months
|
lactate production
Time Frame: 6 months
|
6 months
|
max. Watt load
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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