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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Bellvitge

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years

Participation in another clinical trial

Moderate or severe cognitive impairment in the absence of a competent caregiver

Absence of social support

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalised treatment

    Behavioral

    Patients going through a personalized intervention program

  • Usual Care

    Other intervention

    Usual cardiac rehabilitation program

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: Standard of careActive comparator 1 intervention
Group B: Personalized intervention programExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Physical Activity. IPAQ

Adherence to physical activity will be evaluated with the International Physical Activity Questionnaire (IPAQ). The IPAQ classifies individuals into three categories of physical activity level based on intensity, frequency, and total energy expenditure (measured in MET·minutes/week): Category 1: Low Physical Activity: The person does not meet the criteria for moderate or high physical activity. Considered sedentary or insufficiently active. Category 2: Moderate Physical Activity. A person meets any of the following: * 3 days/week of vigorous activity ≥20 minutes/day, or * 5 days/week of moderate activity and/or walking ≥30 minutes/day, or * 5 days/week of any combination of walking, moderate, or vigorous activity totaling ≥600 MET·minutes/week. Category 3: High Physical Activity. A person meets either: * 3 days/week of vigorous activity accumulating ≥1,500 MET·minutes/week, or * 7 days/week of any combination of walking, moderate or vigorous activity totaling ≥3,000 MET·minutes/week

Time frame
First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge
2

Physical Activity. Podometer

According to pedometer readings which will be given to patients (steps/day), physical activity is categorized as follows: Sedentary or inactive \< 5,000 steps/day Low active 5,000-9,999 steps/day Active 10,000-12,499 steps/day Very active ≥ 12,500 steps/day

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

Psychological status

Psychological status will be evaluated for screening of anxiety and depression (PHQ-9 and GAD-7 scales). The PHQ-9 is a 9-item questionnaire used to screen for depression. Each item is scored from 0 (not at all) to 3 (nearly every day), with a total score range of 0-27. Cut-off points: 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression The GAD-7 is a 7-item scale assessing generalized anxiety. Each item is scored 0-3 (same as PHQ-9), total score range: 0-21. Cut-off points: 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety A score ≥10 on either scale suggests clinically relevant symptoms, warranting further evaluation.

Time frame
First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst Visit and 6 months after hospital discharge
4

Dietary Changes

ChatGPT Plus To assess dietary changes, we will use two validated tools: the DEBQ (Dutch Eating Behavior Questionnaire) and the PREDIMED Mediterranean Diet questionnaire. The DEBQ evaluates emotional, external, and restrained eating behaviors using 33 items rated on a 5-point scale (from "never" to "very often"). It helps identify if a patient eats more in response to emotions, sensory cues, or dieting efforts. Higher scores in each subscale indicate a stronger influence of that behavior on eating patterns. The PREDIMED questionnaire has 14 questions and measures adherence to the Mediterranean diet. Each healthy habit (e.g., using olive oil, eating fruits/vegetables, low processed food intake) scores 1 point. Scores ≥9 = good adherence, \<9 = low adherence. These tools allow monitoring of diet quality and behavior-related eating changes

Time frame
In-hospital evaluation and 6 months after hospital discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut d'Investigació Biomèdica de Bellvitge

Lead sponsor

Hospital Universitari de Bellvitge

Collaborator

Fundació La Marató de TV3

Collaborator