Clinical trial NCT03643536: 12-week Exercise-based Program in Myocardial Revascularization Subjects
Official title: Effects of a 12-week Exercise-based Program on Quality of Life in Myocardial Revascularization Subjects With Normal and Reduced Left Ventricular Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: left ventricular ejection fraction; quality of life
Lead sponsor: Fundación del Caribe para la Investigación Biomédica
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A prospective controlled before-after study
Primary purpose: TREATMENT

Brief summary: To determine if a 12-week physical exercise program (12-WPEP), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) with different left ventricular ejection fraction (LVEF) might improve the health-related quality of life (HRQOL).

Detailed description: Percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) are interventions that can reduce cardiovascular symptoms such as dyspnea and angina. The life quality and the functional capacity improved in the subjects who underwent surgery. However, new cardiac events, death and obstruction of the bypass placed can exist. To diminish these risks, national and international guides recommend cardiac rehabilitation (CR) for people with coronary disease, who have suffered a myocardial infarction and are subjected to CABG and PCI. A 20-30% reduction of morbidity and mortality can be obtained with the use of CR. According to the European Society of Cardiology (ESC), the American Heart Association (AHA) and the American College of Cardiology (ACC), CR is a recommendation Class Type I, in subjects treated with PCI and CABG. This includes prescribed physical exercises, education, and counseling to modify the effects of coronary heart disease and improve long-term survival. Exercise-based cardiac rehabilitation is an effective and safe therapy to be used in the management of clinically stable patients following PCI or CABG. The maximum oxygen uptake (VO2max) is improved by the exercise carried out during CR, optimizing the physical condition and health-related quality of life (HRQOL).

The HRQOL is considered a very important criterion used to evaluate the effectiveness of different treatments in patients with coronary disease, and is defined by subjective evaluation regarding the current activities of health care and health promotion; it indicates the personal perception in various aspects such as the recovery of the functional, labor, sexual and social capabilities of the patient, factors that have great importance in the evolution of the patient; this perception is considered the best indicator of quality of life, and has become a key concept for the decision making. In this study, we will evaluate the effects of a physical exercise program in the health-related quality of life of subjects following CABG or PCI with normal and reduced left ventricular ejection fraction (LVEF)

Eligibility criteria: Inclusion Criteria:

- CABG or post-PCI subjects and agreed to participate by signing the informed consent form.

Exclusion Criteria:

* Subjects with musculoskeletal limitations for physical exercise, untreated ventricular arrhythmias, with the presence of residual pericardial effusion, history of intermittent claudication or left ventricular ejection fraction \<30% measured by 2D-echocardiography

Primary outcomes:
measure: Health-related quality of life (HRQOL)
timeFrame: 12 weeks after the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Fundacion del Caribe para la Investigacion Biomedica (Fundacion Bios)
state: Atlantico
Study officials:
affiliation: Fundacion del Caribe para la Investigacion Biomedica
name: Miguel Urina-Triana, PhD ( c)
role: STUDY_DIRECTOR
affiliation: Fundacion del Caribe para la Investigacion Biomedica
name: Mirary Mantilla-Morron
role: PRINCIPAL_INVESTIGATOR
References: