Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation (APIC)

Elsan

Status: Not yet enrolling

Conditions: Coronary Patient; Individualised Physical Activity Program

Treatments: Other: activity program; Other: no Physical Activity program; Other: Individuals activity programs

Study type: Interventional

Funder types: Other

Identifiers

NCT06345807

2023-A02617-38

Details and patient eligibility

About

The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-infarction coronary artery patient aged 18 years and older, with no gender difference.
• Patients engaged in a follow-up care and cardiovascular rehabilitation program at the Supervaltech center.
• Patient at low to moderate RARE risk of complication (RARE score 2 to 3)
• Patients equipped with smartphones, laptops or other equipment compatible with downloading an application with their personal ID
• Patient able to understand French for the purpose of conducting the study.
• Affiliated member or beneficiary of a social security scheme.
• Participant who has been informed and has given free, informed and written consent (no later than the day of inclusion and before any examination required by the research).

Exclusion criteria

• Patients with a formal contraindication to physical activity such as: unstabilized coronary syndrome, decompensated heart failure, severe ventricular arrhythmias, intracardiac thrombus at risk embolic, PAH, moderate pericardial effusion, history of thrombophlebitis with or without pulmonary embolism, severe and/or symptomatic left ventricular ejection obstruction.
• Patients with ongoing infectious disease
• Participant whose physical and/or psychological health is severely impaired, which in the opinion of the investigator may affect the study participant's compliance.
• Participant included in other research
• Participant in a period of exclusion from another research still in progress at the time of inclusion.
• Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
• Pregnant, breastfeeding or parturient women.
• Participant hospitalized without consent.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

Individualized physical activity program

Experimental group

Treatment:

Other: Individuals activity programs

Physical Activity program defined without optimisation

Active Comparator group

Treatment:

Other: activity program

no Physical Activity program

Other group

Treatment:

Other: no Physical Activity program