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

NCT06472414 | Recruiting DMC

• 1 other identifier: 2022.11208.BD
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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)

Conditions

Cardiovascular Diseases

Keywords

Secondary Prevention; Phase III; Personalized; Physical activity counselling; Supervised; Exercise training; Women; Goal-oriented; Long Term

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (16)

• Sociodemographic information

  At baseline

• Self-reported Clinical History

  At baseline

• Medical Information

  At baseline

• Enrolment

  At 3-months

• Change in Cardiorespiratory Fitness

  At 6-months

Study Arms (2)

Women-Focused Group (WFG)

EXPERIMENTAL

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.

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

Standard Care Group (SCG)

ACTIVE COMPARATOR

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.

Behavioral: Supervised Exercise Training Sessions

Interventions

Individualized Counselling Sessions BEHAVIORAL

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.

Women-Focused Group (WFG)

Educational Women-Focused Sessions BEHAVIORAL

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.

Women-Focused Group (WFG)

Supervised Exercise Training Sessions BEHAVIORAL

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.

Standard Care Group (SCG); Women-Focused Group (WFG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lisbon: lead
• Egas Moniz - Cooperativa de Ensino Superior, CRL: collaborator

Study Sites (1)

Cardiovascular Centre of the University of Lisbon (CCUL)

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Madalena Lemos Pires, Masters

  Cardiovascular Centre of the University of Lisbon, Faculty of Medicine of Lisbon

  PRINCIPAL INVESTIGATOR

• Ana Abreu, PhD

  ISAMB, IMP&SP, Faculty of Medicine of the University of Lisbon

  STUDY DIRECTOR

• Xavier Melo, PhD

  Egas Moniz School of Health and Science

  STUDY CHAIR

Central Study Contacts

Madalena Lemos Pires, Masters

CONTACT

+351919099699; madalenap@edu.ulisboa.pt

Xavier Melo, PhD

CONTACT

xmelo@egasmoniz.edu.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by the same experts in every time point. They will be blinded to the group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 25, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact madalenap@edu.ulisboa.pt

Locations

PT (1)