Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06472414

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

Led by University of Lisbon · Updated on 2025-01-28

82

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

Sponsors

U

University of Lisbon

Lead Sponsor

E

Egas Moniz - Cooperativa de Ensino Superior, CRL

Collaborating Sponsor

AI-Summary

What this Trial Is 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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented cardiovascular disease including coronary artery disease, previous myocardial infarction, coronary revascularization, heart failure, heart valve surgery, cardiac devices, or congenital heart disease
  • Completion of phase II cardiovascular rehabilitation program or within 6 months of cardiovascular disease diagnosis if no phase II was done
  • Clinically stable with no contraindications to exercise training
Not Eligible

You will not qualify if you...

  • Inability to comply with exercise testing or training guidelines
  • Unable to give informed consent
  • Significant unstable or limiting other health conditions such as arthritis, metabolic disorders, severe visual, cognitive, or mental illness

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cardiovascular Centre of the University of Lisbon (CCUL)

Lisbon, Portugal

Actively Recruiting

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Research Team

M

Madalena Lemos Pires, Masters

CONTACT

X

Xavier Melo, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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