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

Ana Zuazagoitia, Gonzalo Grandes, Jesús Torcal, Iñaki Lekuona, Pilar Echevarria, Manuel A Gómez, Mar Domingo, Maria M de la Torre, Jose I Ramírez, Imanol Montoya, Juana Oyanguren, Ricardo Ortega-Sánchez Pinilla, EFICAR Group (Ejercicio Físico en la Insuficiencia Cardiaca), Ana Zuazagoitia, Gonzalo Grandes, Jesús Torcal, Juana Oyanguren, Imanol Montoya, Kepa Latorre, Jesús Torcal, Juan Manuel Chirapozu, Verónica Arce, Juana Oyanguren, Milagros Oses, Jose Antonio Alarcon, Pilar Echevarria, Santiago Palomar, Ma Soledad Arietaleanizbeaskoa, Agurtzane Otxandategi, Agurtzane Pascual, Manuel Angel Gómez Marcos, Luis García Ortiz, Ignacio Santos, Maximiliano Diego, Ignacio Cruz, Javier Moreiras, José I Recio Rodríguez, Pedro Pavón, Cándido Martín, Magali Urrea, Guillem Pera, Pere Torán, Miguel Angel Muñoz, Elena Briones, Maria Giné, Mar Domingo, Esther Ros, Carlos Martin, Josep Lupón, Ma del Mar de la Torre, Amparo Gómez Arranz, Aventina de la Cal de la Fuente, Miguel Angel Díez, Carmen Fernández Alonso, Marta Menéndez Suárez, Susana Sánchez Ramón, José Ignacio Ramírez Manent, Isabel Torrens Darder, María Albaladejo Blanco, Bernardino Oliva Fanlo, Margarita Isabel Moyà Seguí, Alfonso Leiva, Andrés Grau Sepúlveda, Manuel Sarmiento Cruz, Miguel Porcel Lladó, Carlos Radúan de Paramo, María del Mar Torrens Darder, Joana Tortella Morro, Rafael Saiz García, Ana Zuazagoitia, Gonzalo Grandes, Jesús Torcal, Iñaki Lekuona, Pilar Echevarria, Manuel A Gómez, Mar Domingo, Maria M de la Torre, Jose I Ramírez, Imanol Montoya, Juana Oyanguren, Ricardo Ortega-Sánchez Pinilla, EFICAR Group (Ejercicio Físico en la Insuficiencia Cardiaca), Ana Zuazagoitia, Gonzalo Grandes, Jesús Torcal, Juana Oyanguren, Imanol Montoya, Kepa Latorre, Jesús Torcal, Juan Manuel Chirapozu, Verónica Arce, Juana Oyanguren, Milagros Oses, Jose Antonio Alarcon, Pilar Echevarria, Santiago Palomar, Ma Soledad Arietaleanizbeaskoa, Agurtzane Otxandategi, Agurtzane Pascual, Manuel Angel Gómez Marcos, Luis García Ortiz, Ignacio Santos, Maximiliano Diego, Ignacio Cruz, Javier Moreiras, José I Recio Rodríguez, Pedro Pavón, Cándido Martín, Magali Urrea, Guillem Pera, Pere Torán, Miguel Angel Muñoz, Elena Briones, Maria Giné, Mar Domingo, Esther Ros, Carlos Martin, Josep Lupón, Ma del Mar de la Torre, Amparo Gómez Arranz, Aventina de la Cal de la Fuente, Miguel Angel Díez, Carmen Fernández Alonso, Marta Menéndez Suárez, Susana Sánchez Ramón, José Ignacio Ramírez Manent, Isabel Torrens Darder, María Albaladejo Blanco, Bernardino Oliva Fanlo, Margarita Isabel Moyà Seguí, Alfonso Leiva, Andrés Grau Sepúlveda, Manuel Sarmiento Cruz, Miguel Porcel Lladó, Carlos Radúan de Paramo, María del Mar Torrens Darder, Joana Tortella Morro, Rafael Saiz García

Abstract

Background: Quality 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/design: Multicenter 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.

Discussion: A 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 registration: Clinical Trials.gov Identifier: NCT01033591.

Figures

Figure 1
Figure 1
Algorithm of the study.
Figure 2
Figure 2
Exercise program for the EFICAR group.

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Source: PubMed

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