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

Not Applicable

Not yet recruiting

• Conditions: Individualised Physical Activity Program; Coronary Patient
• Interventions: Other: Individuals activity programs; Other: no Physical Activity program; Other: activity program

• Registration Number: NCT06345807
• Lead Sponsor: Elsan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Status Verified: 2024-04
• Study First Posted: 2024-04-03
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05
• Study Start: 2024-05
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized physical activity program	Individuals activity programs	-
no Physical Activity program	no Physical Activity program	-
Physical Activity program defined without optimisation	activity program	-

Primary Outcome Measures

Name	Time	Method
6 minutes walk test	18 months	patient behaviour change measured with the six minute walk test distance