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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Cardiovascular Centre of the University of Lisbon (CCUL)
RECRUITING
Lisbon
Contact Information
Primary
Madalena Lemos Pires, Masters
madalenap@edu.ulisboa.pt
+351919099699
Backup
Xavier Melo, PhD
xmelo@egasmoniz.edu.pt
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2027-04
Participants
Target number of participants: 82
Treatments
Experimental: Women-Focused Group (WFG)
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.
Active_comparator: Standard Care Group (SCG)
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.
Sponsors
Leads: University of Lisbon
Collaborators: Egas Moniz - Cooperativa de Ensino Superior, CRL

This content was sourced from clinicaltrials.gov