Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05385341
Status:
WITHDRAWN
Last Update Posted:
2023-07-24
First Post:
2020-04-21
Brief Title:
Rehabilitation Exercise with MObile Technology and Education After Acute Coronary Syndrome
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Is Tele-rehabilitation an Efficacious Alternative to Traditional Center Based Cardiac Rehabilitation After Acute Coronary Syndrome
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The start of the study took too long and there are already many publications on the subject
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMOTE-ACS
Brief Summary:
Despite a clear indication of grade Ia cardiac rehabilitation CR is dramatically underutilized after acute coronary syndrome with less than 30 of patients addressed in France Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation However studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation
Detailed Description:
After acute coronary syndrome ACS it is recommended to propose a cardiac rehabilitation CR program in order to reduce the risk of recidive to improve the quality of life and to reduce the risk of disabilities Traditional CR which is most of the time center-based is underutilized with less than 30 of patients addressed en France Therefore Télé-Cardiac Rehabilitation Télé-RCV has been developped progressively since the eighties showing comparable efficacity compared with CR concerning physical fitness The investigative team had previously published results showing that telephone support guided by accelerometers could improve physical activity However In France device allowing telemonitoring online of heart rate are not available Moreover the investigators have not yet developped remote therapeutic education which is proposed in CR programs Thus the present study planned to develop and evaluate aTele-RCV solution aimed to monitor exercise training at home and to educate remotely patient after ACS
The device is an association of a heart rate monitor a blood pressure testing a balance linked with a full web secured application connecting patient and caregivers In the intervention group Tele-RCV is proposed during 20 sessions containing 2h of exercise training combined with 6h of therapeutic tele-education In the control group CR is proposed during 20 sessions with the same volume of exercise training and therapeutic education After randomisation patient are allocated to one of the two groups The evaluation of the primary and secondary outcomes are realized at the beginning at one month only walking tests and at 2 months A social evaluation is done in parallel to test the acceptability for the Télé-RCV compared with CR
The device is an association of a heart rate monitor a blood pressure testing a balance linked with a full web secured application connecting patient and caregivers In the intervention group Tele-RCV is proposed during 20 sessions containing 2h of exercise training combined with 6h of therapeutic tele-education In the control group CR is proposed during 20 sessions with the same volume of exercise training and therapeutic education After randomisation patient are allocated to one of the two groups The evaluation of the primary and secondary outcomes are realized at the beginning at one month only walking tests and at 2 months A social evaluation is done in parallel to test the acceptability for the Télé-RCV compared with CR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None