Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01761448
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2012-07-16
Brief Title:
Heart Cycle GEx Guided- Exercise- Main Trial
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Guided Exercise GEx for CAD Patients
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEx
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 patients 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 weeks50 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 assistantPDA 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
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 assistantPDA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None