12-week Exercise-based Program in Myocardial Revascularization Subjects

NCT ID: NCT03643536

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2015-03-31

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)

Conditions

Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

12-WPEP in subjects with reduce LVEF

Intervention: a 12 week physical exercise program in the health-related quality of life of CABG or PCI subjects with LVEF by 2D-echocardiography between 30-54%. The quality of life was measured using SF-36 questionnaire

Group Type: EXPERIMENTAL

12-WPEP

Intervention Type: OTHER

The 12-WPEP (week physical exercise program) was carried out in 3 sessions each 40 or 60minutes with alternate days per week during 3 months, and with an intensity between 40 to 80 percent of their VO2 max, as the AHA recommends

12-WPEP in subjects with normal LVEF

Intervention: a 12 week physical exercise program in the health-related quality of life of or PCI subjects with LVEF by 2D-echocardiography≥ 55% (control group)The quality of life was measured using SF-36 questionnaire

Group Type: ACTIVE_COMPARATOR

12-WPEP

Intervention Type: OTHER

The 12-WPEP (week physical exercise program) was carried out in 3 sessions each 40 or 60minutes with alternate days per week during 3 months, and with an intensity between 40 to 80 percent of their VO2 max, as the AHA recommends

Interventions

12-WPEP

The 12-WPEP (week physical exercise program) was carried out in 3 sessions each 40 or 60minutes with alternate days per week during 3 months, and with an intensity between 40 to 80 percent of their VO2 max, as the AHA recommends

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación del Caribe para la Investigación Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Urina-Triana, PhD ( c)

Role: STUDY_DIRECTOR

Fundacion del Caribe para la Investigacion Biomedica

Mirary Mantilla-Morron

Role: PRINCIPAL_INVESTIGATOR

Fundacion del Caribe para la Investigacion Biomedica

Locations

Fundacion del Caribe para la Investigacion Biomedica (Fundacion Bios)

Barranquilla, Atlántico, Colombia

Countries

Colombia

Other Identifiers

2018200801

Identifier Type: -

Identifier Source: org_study_id