NCT07038265

Patient-centered Personalized Cardiac Rehabilitation in Post Acute Coronary Syndrome (BREAK-trial)

Patient-centered Cardiac rehaBilitation pRogramE in Post Acute Coronary Syndrome:Identification of Key Barriers and Evaluation of Personalized Intervention (BREAK-trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Institut d'Investigació Biomèdica de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare an integrated, multidisciplinar patient-centered CRP (Cardiac Rehabilitation Program) (intervention group) especially focused on covering the needs for the female and fragile population to the usual care conventional CRP (control group)

Detailed description

The Break-CR study is designed as an unicentric, open, randomized controlled trial, blind end-point evaluation and adjudication, to compare the feasibility, efficacy, and safety of a patient-centered CR-program versus usual care in patients after an acute coronary syndrome (ACS). The project aims to identify these barriers and design a CR-intervention to overcome said barriers and evaluate its usefulness in clinical practice. The first part of this study consists of a qualitative study to specifically determine barriers, difficulties and facilitators that condition the participation of women in the CRPs, the second part of the study is undertaken to address the underrepresentation of women in CRPs and provide a solution to the recognized need to redesign CR programs to respond to the unique physiological and psychosocial needs of women. The aim is to design a groundbreaking intervention model that will respond to this need because it will incorporate all the factors on which a CR programme should be based, from a woman's perspective, from the beginning to the end, while also adressing the needs of the fragile portion ACS survivors. It is hypothesized that the Break-CR program would be able to demonstrate greater improvements in incorporation and adherence of women and fragile patients to CR-programs, enhanced functional benefits, as well as improve patient-satisfaction and quality of life. Finally, the fundamental purpose is to enhance poor health outcomes of women and fragile patients with coronary diseases and to provide a solution that will contribute to bridge the health gap that exists in the field of cardiovascular diseases in health systems.

Conditions

• Acute Coronary Syndromes (ACS)
• Cardiac Rehabilitation
• Frailty
• Women
• Women's Health

Interventions

Type	Name	Description
BEHAVIORAL	Personalised treatment	Patients going through a personalized intervention program
OTHER	Usual Care	Usual cardiac rehabilitation program

Timeline

• Start date: 2025-05-26
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: Spain