Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01627457
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2012-06-21
Brief Title:
Heart Cycle Prestudy
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Heart Cycle Prestudy Guided Exercise GEx for Coronary Artery Disease Patients CAD GEx Home Application Testing
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:
PreGEx
Brief Summary:
In this Prestudy which will be followed by the multicentral GEx- main-trial the feasibility of a new cardiac rehabilitation device GEx system is proved with coronary heart disease patients who participate in cardiac rehabilitation training exercise at the rehabilitation clinic phase II and subsequently at home phase III The GEx system consists of a easy-to-wear vest with integrated electrodes to measure electrocardiogram ECG respiration and activity furthermore of a PDA to collect and store the monitored data and a cradle to charge the batteries Several physiological parameters are extracted from thes measured vital signs like heart rate breathing rate ECG and activity In this pretrial first the GEx sensor system is validated during guided exercise of the patients in the rehabilitation clinic phase II Subsequently at home phase III the practicability of the vest and sensors and possible technical problems in real- life use are proved This means after moderate training like walking cycling or running at home for 3 weeks patients will report the feasibility of usage The ECG data and breathing- frequency data will be analyzed to see if data are recorded and transmitted well in regard to technical problems
Detailed Description:
During the rehabilitation process phase II of patients with coronary heart disease CAD 30 patients are recruited and are made familiar with the new Guided Exercise GEx training system during exercise training they are supervised and provided with training instructions by a medicine for 3 times a week 3 weeks long At the beginning and at the end of the study the patient has to undergo several tests of the clinical routine such as a cardiopulmonary test CPX echocardiography and lactate measurementadditionally this test will be registered by the system to obtain information about the detection of heart rate rise for example Data will be analyzed for quality of heart rate measurement and data acquisition by the device
In a second step the GEx system is handed to these 30 patients when they leave in-patient cardiac rehabilitation CR The pre-trial serves to gather information about the practicability and technical problem during real-life use Therefore at home these 30 patients will continue with moderate endurance training like walking cycling or running while wearing the GEx system three times a week for 3 weeks After three weeks patients will come back to the clinic to undergo the end examination and to report the feasibility of usage The ECG data and breathing frequency data will be analyzed to see if data are recorded and transmitted well in regard to technical problems
If accurate and safe data are received the following GEx- main- trial ID 11-020 will investigate the GEx- system for CAD patients in regard to improvement of physical capacities obtained in long term adherence to home based rehabilitation programs phase III including feedback to patients compared to national standard rehabilitation
In a second step the GEx system is handed to these 30 patients when they leave in-patient cardiac rehabilitation CR The pre-trial serves to gather information about the practicability and technical problem during real-life use Therefore at home these 30 patients will continue with moderate endurance training like walking cycling or running while wearing the GEx system three times a week for 3 weeks After three weeks patients will come back to the clinic to undergo the end examination and to report the feasibility of usage The ECG data and breathing frequency data will be analyzed to see if data are recorded and transmitted well in regard to technical problems
If accurate and safe data are received the following GEx- main- trial ID 11-020 will investigate the GEx- system for CAD patients in regard to improvement of physical capacities obtained in long term adherence to home based rehabilitation programs phase III including feedback to patients compared to national standard rehabilitation
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