Patient-centered Personalized Cardiac Rehabilitation in Post Acute Coronary Syndrome (BREAK-trial)
NCT ID: NCT07038265
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
202 participants
INTERVENTIONAL
2025-05-26
2027-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
The trial will be designed and implemented by the BREAK Steering Committee. Oversight of the study will be conducted by the Chair and the two Co-Chairs in liason with the BREAK Executive Committee. Safety will be reported by local investigators in accordance with the current legislation that regulates pharmacovigilance in Spain.
End-point evaluation of the primary outcome will be performed by an independent end-point committee blinded to the group allocation of patients.
SUPPORTIVE_CARE
SINGLE
Study Groups
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Standard of care
Usual cardiac rehabilitation program
Usual Care
Usual cardiac rehabilitation program
Personalized intervention program
BREAK intervention group with more alternatives of aerobic and strength exercises and also offering remote options for fragile patients
Personalised treatment
Patients going through a personalized intervention program
Interventions
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Personalised treatment
Patients going through a personalized intervention program
Usual Care
Usual cardiac rehabilitation program
Eligibility Criteria
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Inclusion Criteria
2. Patients discharged within the last 30 days after an admission for ACS or in the discharge planning process for an admission for ACS.
3. The patient is able to fully communicate with the research team and comply with all study procedures.
4. The patient voluntarily signs and dates the informed consent form approved by the ethics committee
Exclusion Criteria
2. Participation in another clinical trial
3. Moderate or severe cognitive impairment in the absence of a competent caregiver
4. Absence of social support
5. Institutionalized patient
6. Life expectancy \<1 year
7. Candidates for end-of-life care
8. Severe psychiatric illness
9. Planned cardiac surgery including transplant or circulatory support implant
10. Death before hospital discharge in patients included in the hospital discharge planning phase
11. Carrier of heart transplant.
12. Patient unable or refusing to give written informed consent to participate
13. Patients who, in the opinion of the investigator, are unsuitable candidates for the study
18 Years
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Fundació La Marató de TV3
OTHER
Institut d'Investigació Biomèdica de Bellvitge
OTHER
Responsible Party
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Cristina Enjuanes Grau
Coordinator of Community Heart Failure Unit, Cardiology Department. MD, PhD
Principal Investigators
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Cristina Enjuanes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut d'Investigació Biomèdica de Bellvitge
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IDIBELL- 202309 10
Identifier Type: -
Identifier Source: org_study_id
202309 10
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
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