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Open Access Highly Accessed Study protocol

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 Zuazagoitia1*, Gonzalo Grandes1, Jesús Torcal12, Iñaki Lekuona3, Pilar Echevarria4, Manuel A Gómez5, Mar Domingo6, Maria M de la Torre7, Jose I Ramírez8, Imanol Montoya1, Juana Oyanguren2, Ricardo Ortega-Sánchez Pinilla9 and the EFICAR Group (Ejercicio Físico en la Insuficiencia Cardiaca)10

Author Affiliations

1 Primary Care Research Unit of Bizkaia, Basque Health Service-Osakidetza , CAIBER, Bilbao, Spain

2 Basauri-Ariz Health Centre, Basque Health Service - Osakidetza, Bizkaia, Spain

3 Cardiology Service, Galdakao Hospital, Basque Health Service - Osakidetza, Bizkaia, Spain

4 Galdakao Health Centre, Basque Health Service - Osakidetza, Bizkaia, Spain

5 La Alamedilla Health Centre, Castilla y León Health Service - SACYL, Salamanca, Spain

6 Sant Roc Health Centre. Catalan Health Service - ICS. Barcelona. Spain

7 Casa de Barco Health Centre Castilla y León Health Service - SACYL, Valladolid, Spain

8 Calviá Health Centre. Balearic Islands Health Service - IBSALUT, Mallorca, Spain

9 Santa Barbara Health Centre, Castilla-La Mancha Health Service - SESCAM, Toledo, Spain

10 redIAPP: Red de Investigación en Actividades Preventivas y Promoción de la Salud, Spain

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BMC Public Health 2010, 10:33  doi:10.1186/1471-2458-10-33

Published: 25 January 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.

Trial Registration

Clinical Trials.gov Identifier: NCT01033591