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
Zuazagoitia, Ana (Osakidetza Servicio Vasco de Salud)
Grandes, Gonzalo (Osakidetza Servicio Vasco de Salud)
Torcal, Jesús (Osakidetza Servicio Vasco de Salud)
Lekuona, Iñaki (Osakidetza Servicio Vasco de Salud)
Echevarria, Pilar (Osakidetza Servicio Vasco de Salud)
Gómez, Manuel A. (Sanidad de Castilla y Léon)
Domingo, Mar (Institut Català de la Salut)
De la Torre, María M. (Sanidad de Castilla y Léon)
Ramírez, José I. (Illes Balears. Servei de Salut)
Montoya, Imanol (Osakidetza Servicio Vasco de Salud)
Oyanguren, Juana (Osakidetza Servicio Vasco de Salud)
Ortega-Sánchez Pinilla, Ricardo (Servicio de Salud de Castilla-La Mancha)
Martín-Cantera, Carlos (Grupo EFICAR (Ejercicio Físico en la Insuficiencia Cardiaca))
redIAPP. Grupo EFICAR (Ejercicio Físico en la Insuficiencia Cardiaca)

Date:	2010
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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; Versió publicada
Published in:	BMC public health, Vol. 10, N. 33 (January 2010) , p. 1-10, ISSN 1471-2458

DOI: 10.1186/1471-2458-10-33
PMID: 20100317

10 p, 422.7 KB

Additional file 1 2 p, 12.5 KB

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