Effects of a Women-Focused Maintenance Cardiovascular Rehabilitation Program on Adherence, Health Related Physical Fitness, and Quality of Life: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
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)
详细描述
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:
- body composition through bioimpedance
- clinical and demographic information with questionnaires
- behaviour regulation through BREQ-2 questionnaire
- quality of life with SF-36 questionnaire
- cardiovascular rehabilitation barriers with CRBS questionnaire
- anxiety and depression with HADS questionnaire
- mediterranean diet adherence with PREDIMED questionnaire
- sleep quality with PSQI questionnaire
- handgrip strength through dynamometer
- functional capacity through cardiopulmonary exercise testing
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes will be assessed by the same experts in every time point. They will be blinded to the group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Adherence
时间窗: End of first month, end of second month, end of third month, end of fourth month, end of fifth month, end of sixth month.
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.
次要结局
- 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)
- Change in maximal isometric handgrip strength(At 6-months)
- Change in physical activity levels(At 3-months and at 6-months)
- Change in sedentary behaviour(At 3-months and at 6-months)
- Pittsburgh Sleep Quality Index (PSQI) to measure change in Sleep Quality(At 3-months and at 6-months)
- Change in body mass index (BMI)(At 6-months)
- Change in body composition(At 6-months)
- Prevención con Dieta Mediterránea (PREDIMED) to measure Mediterranean diet adherence(At 6-months)
- Behavioural Regulation in Exercise Questionnaire 2 (BREQ-2) to measure change in Behaviour Regulation(Baseline, at 3-months and at 6-months)
- Short Form-36 Health Survey (SF-36) to measure change in Quality of Life(At 6-months)
- Cardiovascular Rehabilitation Barriers Scale (CRBS) to measure change in barriers to cardiovascular rehabilitation programs(Baseline, at 3-months and at 6-months)
- Hospital Anxiety and Depression Scale (HADS) to measure change in Anxiety and Depression(At 6-months)
研究者
Madalena Lemos Pires
Principal Investigator
University of Lisbon