NCT06472414

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

Effects of a Women-Focused Maintenance Cardiovascular Rehabilitation Program on Adherence, Health Related Physical Fitness, and Quality of Life: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: University of Lisbon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Individualized Counselling Sessions	Four 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.
BEHAVIORAL	Educational Women-Focused Sessions	Five 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.
BEHAVIORAL	Supervised Exercise Training Sessions	Participants 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.

Timeline

• Start date: 2024-10-08
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2024-06-25
• Last updated: 2025-01-28

Locations

1 site across 1 country: Portugal