Addition of Aula de rehabilitación cardiaca versus center-based cardiac rehabilitation programs alone. Effects on the quality of life of women after acute coronary syndrome: a randomized, open-label clinical trial

Abstract

Background: Cardiac rehabilitation programs are strongly recommended in guidelines, but for diverse reasons, women are less likely to be referred than men after an acute coronary syndrome. Even after being referred, women show lower rates of enrolment and completion. Clinical outcome improvements are at least as great in women as in men. When overcoming completion barriers, solutions are reducing the time of enrolment, information campaigns about benefits, increase privacy with women-only programs, a wider variety of exercise modalities, family support, and alternative cardiac rehabilitation models. Objective: The aim of this project is to demonstrate that the use of Aula de rehabilitación cardiaca added to current cardiac rehabilitation programs offers better outcomes in terms of quality of life in women who suffered an acute coronary syndrome. Design: We will conduct a randomized, open-label, controlled, clinical trial including 208 patients who will be assigned to either participate in Aula de rehabilitación cardiaca in addition to centre-based cardiac rehabilitation program or receive cardiac rehabilitation alone. This study will be conducted over a period of four years. During this time, we will assess and compare the changes in the health-related quality of life, depression, and anxiety symptoms of all the participants. Setting: This study protocol will take place in Girona, Catalunya. Participants: The participants will be women adult patients with coronary heart disease who do not show contraindications for physical exercise and have access to internet connection. We will invite the patients of Hospital Universitari Doctor Josep Trueta, who meet the criteria to participate in the trial from June 2022 to August 2023. Methods: A non-probabilistic consecutive method will be used. 208 patients will be assigned randomly to one of the two groups on a 1:1 ratio: Control group n = 104 and intervention group n = 104. A two-year follow-up will be carried out