Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care: The EFICAR study protocol

Abstract

BackgroundQuality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors.Methods/DesignMulticenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables.DiscussionA key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants.Trial RegistrationClinical Trials.gov Identifier: NCT01033591

Aerobic exercise effect on prognostic markers for systolic heart failure patients: a systematic review and meta-analysis

“…Winter et al [71] Data are reported in median Yamamoto et al [72] Study did not report values Zuazagoitia et al [73] It is a protocol registration study …”

Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR

“…Diseño. El estudio EFICAR (NCT01033591) 5 es un ensayo clínico aleatorizado multicéntrico que valora la eficacia de un programa de ejercicio en pacientes con ICFSD. Describimos las características basales de los 150 pacientes incluidos.…”

“…La descripción detallada de recogida de datos clínicos, mediciones antropométricas y analíticas, criterios de inclusión y exclusión ya ha sido previamente publicada en el protocolo del estudio EFICAR 5 .…”

Exercise Capacity in Chronic Heart Failure

“…14,25 The setting for exercise recommendation will vary from self-monitored home exercise to supervised telemetry monitoring with scheduled evaluations to alter and advance therapy. [32][33][34] Furthermore, other factors such as age, race, pharmacologic therapy, depression, sex, income, and comorbidities need to be studied to determine alternative methods to the assessment and prescription of exercise capacity in heart failure. 14,26,[35][36][37][38][39] In addition, the transition from monitored exercise training to home exercise training may also contribute to poor adherence.…”

“…8 Exercise training has been shown to improve exercise capacity and quality of life. 33,36,46,47 To date, the evidence shows that the intensity of training does not directly relate to improvements in exercise capacity; therefore, after discussion with the physician, patients should be encouraged to initiate a low-intensity exercise program that can be maintained. 14 become a routine part of their lives.…”