A Women-Focused Cardiovascular Rehabilitation Program on Adherence, Health Related Physical Fitness, and Quality of Life

Universidade de Lisboa

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Educational Women-Focused Sessions; Behavioral: Individualized Counselling Sessions; Behavioral: Supervised Exercise Training Sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT06472414

2022.11208.BD

Details and patient eligibility

About

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)

Full description

Participants will be recruited from the main public hospitals in the Lisbon area with phase II CR programs [such as, Unidade Local de Saúde (ULS) Santa Maria, ULS São José, and ULS Lisboa Ocidental], after physician referral or from cardiology appointments. Phone calls, face-to-face contact, CR hospital team meetings, social media and flyers will be used.

Posteriorly, the CR cardiologist will assess the clinical exams and confirm eligibility criteria. After informed consent is interpreted and signed, participants will be assessed at the Cardiovascular Exercise and Rehabilitation Laboratory, a research unit from the Cardiovascular Centre of the University of Lisbon in one morning (approximately 2 hours) for the following:

1. body composition through bioimpedance
2. clinical and demographic information with questionnaires
3. behaviour regulation through BREQ-2 questionnaire
4. quality of life with SF-36 questionnaire
5. cardiovascular rehabilitation barriers with CRBS questionnaire
6. anxiety and depression with HADS questionnaire
7. mediterranean diet adherence with PREDIMED questionnaire
8. sleep quality with PSQI questionnaire
9. handgrip strength through dynamometer
10. functional capacity through cardiopulmonary exercise testing
11. physical activity with accelerometer

At 3 months only physical activity, BREQ-2, CRBS and PSQI will be assessed.

In the same morning, if no contra indications to exercise training appear at baseline assessments, participants will be randomly assigned [randomization will be generated by computer (randomizer.org), in blocks by the principal investigator)] to one of two groups:

1. Control: A standard care phase III cardiovascular rehabilitation (CR) program.
2. Intervention: Women-focused CR + standard care.

Both groups will receive the standard care phase III CR program, consisting of supervised exercise training sessions, at the Cardiovascular Rehabilitation Centre of the University of Lisbon (CRECUL). These sessions will be prescribed according to the FITT principle (frequency, intensity, time, type) and to the European Society of Cardiology exercise prescription guidelines. Independently of delivery format (face to face or online), participants will exercise 2 or 3 times/week (60 minutes/session) on non-consecutive days, for 6 months and supervised by exercise physiologists. Participants will be able to choose the schedule they would like to attend according to the program vacancies and the participants availability. Participants will also have the possibility to attend meditation classes in an online format once per week.

The intervention group, in addition, will receive four individualized counselling sessions:

1. after baseline assessments
2. after 1-month of intervention where barriers/facilitators will be discussed
3. after 3-months assessments, to check their feelings towards the program, update goals, and if new strategies are needed
4. after 6-months assessments to discuss results, difficulties perceived, plan the future steps, and clarify any existing doubts

These sessions will be structured according to the tools and methodology provided by the Portuguese Directorate General of Health (Behavioural Change Counselling Manual, and Support Tools for Brief Counselling to Promote Physical Activity) and delivered by a certified exercise physiologist. Besides this, the intervention group will also receive 5 women-focused educational sessions, pre-record by experts according to the theme, in a digital format placed in an online platform and made available at the end of each month. After completing the 6-months assessments, the control group will have the possibility to receive the individualized sessions and the women-focused educational sessions.

To improve retention, the following strategies will be implemented:

• Participants will know that the study is completely voluntary, and all data collected will be confidential
• Participants will be informed that all analyses and exams will be free of charge and important to assess their health status and safety
• The importance of this type of program for an optimal recovery and improved quality of life will be explained
• Ensure that physical exercise sessions will be supervised by specialized exercise physiologists and prescribed according to their needs and clinical condition
• Participants will receive behavioural modification strategies through individualized brief counselling sessions
• Inform participants that they will receive a final report with the assessments results

Statistical analyses: Sociodemographic/clinical characteristics will be analysed using t-tests, chi-square if appropriate, and nonparametric alternative in case of a non-normalized distribution. Generalized estimation equations will be used to estimate the effects between and within-group on primary and secondary outcomes. Intention-to-treat analysis will be performed. Statistical analysis will be performed using SPSS version 29.0 (IBM SPSS Statistics), with significance set at p<0.05. Education, age, and time since CVD diagnosis will be used as co-variables in statistical analysis models.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Women-Focused Group (WFG)

Experimental group

Description:

Following baseline assessments, participants will be contacted for the first of four individualized counselling sessions. These sessions will happen following baseline assessments, after 1 month of enrolment, 3 months after mid-term assessments and following 6-month assessments. Five pre-recorded women focused educational sessions will be sent, one per month. After the first individualized session, participants will enrol exercise sessions (two or three times per week) at a supervised community based mixed-sex phase III cardiovascular rehabilitation program.

Treatment:

Behavioral: Supervised Exercise Training Sessions

Behavioral: Individualized Counselling Sessions

Behavioral: Educational Women-Focused Sessions

Standard Care Group (SCG)

Active Comparator group

Description:

Participants will be allocated to a supervised community based mixed-sex phase III cardiovascular rehabilitation program and contacted to enrol two or three times per week.

Treatment:

Behavioral: Supervised Exercise Training Sessions