NCT05385341

Rehabilitation Exercise with MObile Technology and Education After Acute Coronary Syndrome

Is Tele-rehabilitation an Efficacious Alternative to Traditional Center Based Cardiac Rehabilitation After Acute Coronary Syndrome?

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
OTHER	Telerehabilitation (Tele RCV)	20 home-based sessions monitored by the REMOTE-ACS device and containing 2 hours/day 5 days/7 of exercise training associated with educative sessions.
OTHER	Rehabilitation (RCV)	20 sessions of cardiac rehabilitation will be realized in a rehabilitation center containing exercise training during 2 hours/day 5 days/7 and educative program.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-05-23
• Last updated: 2024-09-25