Clinical trial NCT06472414: A Women-Focused Cardiovascular Rehabilitation Program on Adherence, Health Related Physical Fitness, and Quality of Life
Official title: Effects of a Women-Focused Maintenance Cardiovascular Rehabilitation Program on Adherence, Health Related Physical Fitness, and Quality of Life: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Secondary Prevention
Phase III
Personalized
Physical activity counselling
Supervised
Exercise training
Women
Goal-oriented
Long Term
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: Egas Moniz - Cooperativa de Ensino Superior, CRL
First posted: 2024-06-25
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
timeFrame: End of first month, end of second month, end of third month, end of fourth month, end of fifth month, end of sixth month.
Secondary outcomes:
measure: Sociodemographic information
timeFrame: At baseline
measure: Self-reported Clinical History
timeFrame: At baseline
measure: Medical Information
timeFrame: At baseline
measure: Enrolment
timeFrame: At 3-months
measure: Change in Cardiorespiratory Fitness
timeFrame: At 6-months
measure: Change in maximal isometric handgrip strength
timeFrame: At 6-months
measure: Change in physical activity levels
timeFrame: At 3-months and at 6-months
measure: Change in sedentary behaviour
timeFrame: At 3-months and at 6-months
measure: Pittsburgh Sleep Quality Index (PSQI) to measure change in Sleep Quality
timeFrame: At 3-months and at 6-months
measure: Change in body mass index (BMI)
timeFrame: At 6-months
measure: Change in body composition
timeFrame: At 6-months
measure: Prevención con Dieta Mediterránea (PREDIMED) to measure Mediterranean diet adherence
timeFrame: At 6-months
measure: Behavioural Regulation in Exercise Questionnaire 2 (BREQ-2) to measure change in Behaviour Regulation
timeFrame: Baseline, at 3-months and at 6-months
measure: Short Form-36 Health Survey (SF-36) to measure change in Quality of Life
timeFrame: At 6-months
measure: Cardiovascular Rehabilitation Barriers Scale (CRBS) to measure change in barriers to cardiovascular rehabilitation programs
timeFrame: Baseline, at 3-months and at 6-months
measure: Hospital Anxiety and Depression Scale (HADS) to measure change in Anxiety and Depression
timeFrame: At 6-months
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Cardiovascular Centre of the University of Lisbon (CCUL)
Study officials:
affiliation: Cardiovascular Centre of the University of Lisbon, Faculty of Medicine of Lisbon
name: Madalena Lemos Pires, Masters
role: PRINCIPAL_INVESTIGATOR
affiliation: ISAMB, IMP&SP, Faculty of Medicine of the University of Lisbon
name: Ana Abreu, PhD
role: STUDY_DIRECTOR
affiliation: Egas Moniz School of Health and Science
name: Xavier Melo, PhD
role: STUDY_CHAIR
References: