Cardiovascular disease (CVD) remains leader of global causes of death worldwide and recent documented trends show a rise in acute myocardial infarction in younger women. Compared to men, women have a higher cardiovascular risk due to hypertension, dyslipidaemia, diabetes mellitus, obesity, physical inactivity, and a sedentary lifestyle. Plus, they have additional sex-specific cardiovascular risk factors such as gestational hypertension/diabetes, preterm delivery, premature menopause, and polycystic ovary syndrome.
Cardiovascular rehabilitation (CR) is a Class I, level A, clinical practice guideline recommendation, multidisciplinary secondary prevention program that has been shown to reduce cardiovascular mortality, rehospitalization, and improve quality of life. Despite all established benefits, CR continues to be under referred to women compared to men, with lower enrolment rates and lower adherence to exercise sessions. The reasons for the underuse of CR by women and the main barriers have been widely studied. Thus, sex-specific implementation strategies have been developed to improve adherence, however, the efficacy claims of these interventions are equivocal, as some studies revealed no significative difference regarding adherence between different exercise delivery modes and mixed-sex programs, whereas others revealed greater preference towards women-only programs.
Few randomized controlled trials (RCT) examined the efficacy of CR programs tailored to women in adherence, enrolment, functional capacity, physical activity, body composition, and quality of life. Importantly, to the investigators knowledge, no RCTs used counselling sessions, women-focused educational sessions, personalized follow-ups and supervised exercise sessions as adherence strategies in maintenance CR community programs.
The goal of this RCT is to test whether a women-focused maintenance CR community program increases adherence compared to a standard care. Thus, the investigators hypothesized that:
• The women-focused group will have greater adherence to the CR community program (main outcome)
Participants will:
* Be assessed at baseline, at 3-months and at 6-months * Enrol in a supervised community-based maintenance CR program * Receive individually prescribed exercise sessions (both groups), a tailored package consisting of individual counselling sessions and educational sessions (women-focused group)
Documented cardiovascular disease: angiographically documented coronary artery disease in at least one major epicardial vessel; those that had clinical evidence of coronary artery disease in the form of previous myocardial infarction; or coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention); heart failure, including cardiac transplantation; heart valve surgery or percutaneous implantation of prosthetic valves or clips; left ventricular assist or resynchronization devices, defibrillators or pacemakers; congenital heart disease.
After phase II cardiovascular rehabilitation program completion or after 6 months of cardiovascular disease diagnosis if no phase II was performed.
Clinically stable and with no contraindications to exercise training.
Inability to comply with guidelines for exercise testing/training.
Inability to give informed consent.
Significant limiting and/or unstable co morbidities, such as arthritis, metabolic disorders, visual, cognitive, or serious mental illness.
Parallel
Individualized Counselling Sessions
BehavioralFour counselling sessions led by an experienced exercise physiologist will be provided. At the first session, benefits of cardiovascular rehabilitation (CR), functioning of the CR program, barriers to attendance, strategies to overcome them will be explained and discussed, leading to the choice of the best suitable CR modality/schedule. Physical activity (PA) recommendations will be discussed and an action plan to increase/maintain PA levels and decrease sedentary behaviour will be given. WFG will receive access to an online platform where 4 pre-recorded different exercise sessions will be placed, and a booklet to register weekly PA. The second session will be to discuss barriers and facilitators. For the third session PA goals will be re-established, a new action plan constructed and strategies to overcome barriers given. For the final session, overall feedback, results of the intervention, satisfaction, doubts, knowledge acquired and recommendations for the future will be discussed.
Educational Women-Focused Sessions
BehavioralFive pre-recorded women-focused educational sessions will be placed in an online platform at the end of each month. There will be a first short session explaining the importance of cardiovascular rehabilitation, followed by four sessions regarding: women and cardiovascular disease, benefits of physical exercise in women, women and mental health and women and healthy eating. Each session will have a duration of 10/15 minutes and will be delivered by specialized professionals according to the theme (cardiologists, exercise physiologists, nutritionists, psychologists). After every session, a short Likert-type questionnaire will be applied to assess what they thought of the topic in terms of importance and what they have learned.
Supervised Exercise Training Sessions
BehavioralParticipants will exercise 2-3 times/week (60 min/session), on non-consecutive days, for 6 months (weekly target of 10 kcal/kg). Blood pressure and heart rate (HR) will be measured before and after each session. During exercise, a HR chest strap (POLAR H10) will be used to monitor HR and control intensity. Aerobic prescription will be based on the baseline cardiopulmonary exercise test, each session will start with a 5'-10' minutes warm-up - low to moderate intensity \[\<40% of HR Reserve (HRR), 9-10 Rated Perceived Exertion Borg Scale (RPE)\], mobility and low impact exercises, followed by a 30'-45' minutes of combined training with an aerobic component - moderate intensity (40% to 59% of HRR; 12-14 RPE) using ergometers, aerobic exercises, walking/jogging; and a strength component - 8/10 exercises, 30-80% of 1-Repetition Maximum, 12-15 repetitions, 2 sets - ending with a 5'-10' minute cool down - static/dynamic stretching exercises for all major muscle groups.
Adherence
Number of sessions attended divided by the number of exercise sessions prescribed. Exercise physiologists responsible for the exercise training sessions will register each session attended/missed.
Sociodemographic information
A self-reported online survey will be filled regarding marital, financial, education and work status; distance to the program; previous sports history.
Self-reported Clinical History
A self-reported online survey will be filled regarding sex-specific and traditional cardiovascular risk factors; current medication; other diseases; orthopaedic limitations; cardiovascular rehabilitation history.
Medical Information
Medical charts information will be provided directly by participants or by the responsible physician after participants consent. Information regarding type of cardiovascular disease, type of intervention, date of discharge, date of the cardiovascular event, date of the cardiovascular intervention, number of cardiovascular rehabilitation phase 2 sessions attended, will be registered.
Enrolment
Number of participants who attended at least one exercise session divided by the number of participants who were referred and willing to participate.
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University of Lisbon
Lead sponsor
Egas Moniz - Cooperativa de Ensino Superior, CRL
Collaborator
