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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Individualised Physical Activity Program; Coronary Patient
• Intervention / Treatment: Other: Individuals activity programs; Other: activity program; Other: no Physical Activity program

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: christine Blanc; Phone Number: 0468562895; Email: christine.blanc@elsan.care
• Study Contact Backup: Name: Deva BAS, MD; Phone Number: 0468874022

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized physical activity program	Other: Individuals activity programs; activity program will be adjusted every week by practitioner for each patient following data coming from the wearable device ( connected whatch and bellt for 12 months)
Active Comparator: Physical Activity program defined without optimisation	Other: activity program; pre established program without adjustement. The patient has connected whatch and bellt for 12 months
Other: no Physical Activity program	Other: no Physical Activity program; no Physical Activity (PA)program but just PA recommendations.PA is carried out independently (common practice).The patient has connected whatch and bellt for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walk test	patient behaviour change measured with the six minute walk test distance	18 months

Collaborators and Investigators

• Sponsor: Elsan
• Investigators: Principal Investigator: Deva BAS, MD, Clinique SSR SuperValtech

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; ischemic heart disease; wearables; cardiac rehabilitation
• Other Study ID Numbers: 2023-A02617-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No