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

NCT07038265 | Recruiting

• 2 other identifiers: IDIBELL- 202309 10202309 10
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

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

Keywords

frailty; sarcopenia; cardiac rehabilitation; gender perspective; acute coronary syndrome; coronary artery disease; patient-centered care

Outcome Measures

Primary Outcomes (1)

• Improvement in functional capacity

  The primary endpoint of the study will be a composite functional capacity score, designed to capture the overall improvement in cardiorespiratory fitness following the rehabilitation intervention. This composite score will integrate the standardized change (from baseline to the end of the intervention) in the following four variables: 1. Peak oxygen uptake (VO₂ peak, in ml/kg/min), measured via cardiopulmonary exercise testing (CPET). 2. Six-minute walk distance (6MWD, in meters), assessed using the six-minute walk test. 3. Maximal metabolic equivalents (METs), achieved during CPET. 4. Exercise test duration (in minutes), defined as the total time sustained during the treadmill or cycle ergometer test under a standardized, symptom-limited protocol. Each of these variables will be converted to z-scores based on the distribution of change scores in the study population. The composite score will be calculated as the mean of the four standardized values

  First visit and 3 months after hospital discharge (after completing rehabilitation program)

Secondary Outcomes (13)

• Physical Activity. IPAQ

  First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge

• Physical Activity. Podometer

  First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst visit and 6 months after hospital discharge

• Psychological status

  First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst Visit and 6 months after hospital discharge

• Dietary Changes

  In-hospital evaluation and 6 months after hospital discharge

• Body composition

  First visit and 3 months after hospital discharge (after completing rehabilitation program)

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Usual cardiac rehabilitation program

Other: Usual Care

Personalized intervention program

EXPERIMENTAL

BREAK intervention group with more alternatives of aerobic and strength exercises and also offering remote options for fragile patients

Behavioral: Personalised treatment

Interventions

Personalised treatment BEHAVIORAL

Patients going through a personalized intervention program

Personalized intervention program

Usual Care OTHER

Usual cardiac rehabilitation program

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged ≥ 18 years
• Patients discharged within the last 30 days after an admission for ACS or in the discharge planning process for an admission for ACS.
• The patient is able to fully communicate with the research team and comply with all study procedures.
• The patient voluntarily signs and dates the informed consent form approved by the ethics committee

You may not qualify if:

• Age \<18 years
• Participation in another clinical trial
• Moderate or severe cognitive impairment in the absence of a competent caregiver
• Absence of social support
• Institutionalized patient
• Life expectancy \<1 year
• Candidates for end-of-life care
• Severe psychiatric illness
• Planned cardiac surgery including transplant or circulatory support implant
• Death before hospital discharge in patients included in the hospital discharge planning phase
• Carrier of heart transplant.
• Patient unable or refusing to give written informed consent to participate
• Patients who, in the opinion of the investigator, are unsuitable candidates for the study

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Hospital Universitari de Bellvitge: collaborator
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Frailty; Sarcopenia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Cristina Enjuanes, MD, PhD

  Institut d'Investigació Biomèdica de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Enjuanes Grau, MD, PhD

CONTACT

+34 93 260 7078; cenjuanes@bellvitgehospital.cat

Pablo Morales, MD

CONTACT

+34 93 260 7078; pmorales@idibell.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Community Heart Failure Unit, Cardiology Department. MD, PhD

Model Details: Patients will be recruited during 14 months, and will be followed for a fixed period of 6 months. The study protocol will be approved by the institutional review boards of the center (Bellvitge Biomedical Research Institute, IDIBELL). 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.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: June 26, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)