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INTRODUCCIÓ: Lesions per trànsit (LT), evitables i problema de salut publica. Àmbit d'atenció primària (AP) lloc on investigar i actuar. Possible relació entre malalties cròniques del conductor i LT. MÈTODES: estudi descriptiu, transversal i multicèntric, conductors amb història clínica, Barcelona, 2009. 1900 enquestes personals, mostreig consecutiu. Variables sociodemogràfiques, sobre conducció i salut. RESULTATS: 57,3% homes, 8,5% conductors professionals, 12,5% havia patit una LT, 6% va precisar ajuda mèdica. 51,5% malalts crònics, predominant malalties cardiovasculars i limitacions visuals. CONCLUSIONS: No van trobar relacions significatives entre malalties cròniques i LT. Limitacions:imperfecció dels sistemes de registre, fiabilitat feble de dades autodeclarades, presencia de possibles factors de confusió.

Dispositius electrònics; Cigarretes electròniques; Productes de tabac per escalfament Dispositivos electrónicos; Cigarrillos electrónicos; Productos de tabaco por calentamiento Electronic devices; Electronic cigarettes; Tobacco products for heating Els dispositius electrònics (DE) són sistemes que proporcionen nicotina i altres substàncies en forma d’aerosol inhalable. Van ser introduïts en el mercat l’any 2003 sense estudis preclínics, proves toxicològiques ni assajos de seguretat a llarg termini, tal com requereixen els productes farmacèutics o els productes sanitaris, i no han estat autoritzats com a productes terapèutics. Hi ha dos tipus principals de DE: les cigarretes electròniques (CE) i els productes de tabac per escalfament (PTE). Els seus efectes sobre la salut a llarg termini són desconeguts i, per tant, no hi ha proves que els DE siguin més segurs que el tabac convencional. A curt termini, poden tenir efectes respiratoris similars als de les cigarretes convencionals. L’any 2019, es va descriure una entitat pròpia de lesions pulmonars associades al vapeig (EVALI, de l’anglès E-cigarette or Vaping Product Use-Associated Lung Injury). També s’han notificat diverses afectacions relacionades dels sistemes respiratori, cardiovascular o immunitari, entre d’altres. Els assaigs clínics publicats fins avui no han aclarit si les CE són efectives per deixar de fumar, bàsicament perquè presenten dèficits metodològics importants. Hi ha una gran evidència (OR 4,59) entre l’ús de CE i la posterior conversió d’aquestes persones en fumadors habituals. L’estratègia més efectiva per ajudar les persones fumadores es basa en el suport psicològic o conductual i la utilització de fàrmacs (teràpia substitutiva de nicotina, bupropió i vareniclina). Els professionals sanitaris haurien de desaconsellar les cigarretes electròniques. Los dispositivos electrónicos (DE) son sistemas que proporcionan nicotina y otras sustancias en forma de aerosol inhalable. Se introdujeron en el mercado el año 2003, sin estudios preclínicos, pruebas toxicológicas, ni ensayos clínicos de seguridad a largo plazo, tal como requieren los medicamentos o los productos sanitarios, y no han sido autorizados como producto terapéutico. Hay dos tipos principales de DE, los cigarrillos electrónicos (CE) y los productos de tabaco por calentamiento (PTC). Los efectos a largo plazo sobre la salud de estos productos son desconocidos y, por tanto, no se dispone de pruebas que permitan afirmar que los DE son más seguros que el tabaco convencional. A corto plazo, pueden tener efectos respiratorios similares a los de los cigarrillos convencionales. En el año 2019, se describió una entidad propia de lesiones pulmonares asociadas al vapeo (EVALI: “E-cigarette Vaping product uso Associated Lung Injury”). También se han notificado varias afectaciones en los sistemas respiratorio, cardiovascular e inmunitario entre otros. Los ensayos clínicos publicados hasta el momento no aclaran si los CE son eficaces para dejar de fumar, básicamente, a causa de que presentan déficits metodológicos importantes. Se dispone de fuerte evidencia (ORO 4,59) entre el uso de CE y la posterior conversión a fumadores habituales. La estrategia más efectiva para ayudar a las personas fumadoras se basa en el apoyo psicológico/conductual y la utilización de fármacos (Terapia sustitutiva de nicotina, bupropión y vareniclina). Los profesionales sanitarios deben desaconsejar el uso de cigarrillos electrónicos.

Introduction Studies had not yet overcome the most relevant barriers to physical activity (PA) adherence. An exercise referral scheme (ERS) with mechanisms to promote social support might enhance adherence to PA in the long term. Setting A randomised controlled trial in 10 primary care centres in Spain. Objective To assess the effectiveness of a primary carebased ERS linked to municipal resources and enhancing social support and social participation in establishing adherence to PA among adults over a 15-month period. Participants 422 insufficiently active participants suffering from at least one chronic condition were included. 220 patients (69.5 (8.4) years; 136 women) were randomly allocated to the intervention group (IG) and 202 (68.2 (8.9) years; 121 women) to the control group (CG). Interventions The IG went through a 12-week standardised ERS linked to community resources and with inclusion of mechanisms to enhance social support. The CG received usual care from their primary care practice. Outcomes The main outcome measure was self-report PA with the International Physical Activity Questionnaire and secondary outcomes included stages of change and social support to PA practice. Data collection Participant-level data were collected via questionnaires at baseline, and at months 3, 9 and 15. Blinding The study statistician and research assessors were blinded to group allocation. Results Compared with usual care, follow-up data at month 15 for the ERS group showed a significant increase of self-reported PA (IG: 1373±1845metabolic equivalents (MET) min/week, n=195; CG: 919±1454MET min/week, n=144; P=0.009). Higher adherence (in terms of a more active stage of change) was associated with higher PA level at baseline and with social support. Conclusions Prescription from ordinary primary care centres staff yielded adherence to PA practice in the long term. An innovative ERS linked to community resources and enhancing social support had shown to be sustainable in the long term. Trial registration number NCT00714831; Results.

El fum del tabac té efectes perjudicials sobre la salut i, en el cas de la infància és especialment preocupant per les seves característiques, que fa que assimilin més quantitat de tòxics, en tenir major freqüència respiratòria en relació a l'alçada i pes d'un adult i a més, per la immaduresa pròpia que els fa més sensibles als seus efectes. L'Agència de Salut Pública de Catalunya ha realitzat un estudi, pioner a nivell de l'Estat, que avalua l'efectivitat d'una intervenció breu per reduir el tabaquisme passiu en els nadons a les consultes d'atenció primària. El humo del tabaco tiene efectos perjudiciales sobre la salud y, en el caso de la infancia es especialmente preocupante por sus características, que hace que asimilen más cantidad de tóxicos, al tener mayor frecuencia respiratoria en relación a la altura y peso de un adulto y, además, por la inmadurez propia que los hace más sensibles a sus efectos. La Agencia de Salud Pública de Cataluña ha realizado un estudio, pionero a nivel del Estado, que evalúa la efectividad de una intervención breve para reducir el tabaquismo pasivo en los bebés en las consultas de atención primaria.

La diabetis es una de les malalties mes freqüents a la nostra societat i la qualitat de vida dels pacients amb diabetis i la presència de complicacions estan molt relacionades amb diferents estils de vida. Deixar de fumar és una de les prioritats més importants pels diabètics. Aquest assaig clínic ha demostrat que una intervenció intensiva dóna resultats positius, tant per deixar el tabac com per reduir el nombre de cigarrets en pacients diabètics atesos a l'atenció primària. La diabetes es una de las enfermedades más frecuentes en nuestra sociedad y la calidad de vida de los pacientes con diabetes y la presencia de complicaciones están muy relacionadas con diferentes estilos de vida. Dejar de fumar es una de las prioridades más importantes para los diabéticos. Este ensayo clínico ha demostrado que una intervención intensiva da resultados positivos, tanto para dejar el tabaco como para reducir el número de cigarrillos en pacientes diabéticos atendidos en la atención primaria.

Background: Effective promotion of exercise could result in substantial savings in healthcare cost expenses in terms of direct medical costs, such as the number of medical appointments. However, this is hampered by our limited knowledge of how to achieve sustained increases in physical activity. Objectives: To assess the effectiveness of a Primary Health Care (PHC) based physical activity program in reducing the total number of visits to the healthcare center among inactive patients, over a 15-month period. Research Design: Randomized controlled trial. Subjects: Three hundred and sixty-two (n = 362) inactive patients suffering from at least one chronic condition were included. One hundred and eighty-three patients (n = 183; mean (SD); 68.3 (8.8) years; 118 women) were randomly allocated to the physical activity program (IG). One hundred and seventy-nine patients (n = 179; 67.2 (9.1) years; 106 women) were allocated to the control group (CG). The IG went through a three-month standardized physical activity program led by physical activity specialists and linked to community resources. Measures: The total number of medical appointments to the PHC, during twelve months before and after the program, was registered. Self-reported health status (SF-12 version 2) was assessed at baseline (month 0), at the end of the intervention (month 3), and at 12 months follow-up after the end of the intervention (month 15). Results: The IG had a significantly reduced number of visits during the 12 months after the intervention: 14.8 (8.5). The CG remained about the same: 18.2 (11.1) (P = .002). Conclusions: Our findings indicate that a 3-month physical activity program linked to community resources is a shortduration, effective and sustainable intervention in inactive patients to decrease rates of PHC visits. Trial Registration: ClinicalTrials.gov NCT00714831

Background Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. Methods/design Randomized Controlled Multicentric Trial. Study population: 1060 smokers aged between 18–70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Intervention: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Outcome measures: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Statistical analysis: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. Discussion The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. Trial Registration Clinical Trials.gov Identifier: NCT01494246.

Background: Effective promotion of exercise could result in substantial savings in healthcare cost expenses in terms of direct medical costs, such as the number of medical appointments. However, this is hampered by our limited knowledge of how to achieve sustained increases in physical activity. Objectives: To assess the effectiveness of a Primary Health Care (PHC) based physical activity program in reducing the total number of visits to the healthcare center among inactive patients, over a 15-month period. Research Design: Randomized controlled trial. Subjects: Three hundred and sixty-two (n = 362) inactive patients suffering from at least one chronic condition were included. One hundred and eighty-three patients (n = 183; mean (SD); 68.3 (8.8) years; 118 women) were randomly allocated to the physical activity program (IG). One hundred and seventy-nine patients (n = 179; 67.2 (9.1) years; 106 women) were allocated to the control group (CG). The IG went through a three-month standardized physical activity program led by physical activity specialists and linked to community resources. Measures: The total number of medical appointments to the PHC, during twelve months before and after the program, was registered. Self-reported health status (SF-12 version 2) was assessed at baseline (month 0), at the end of the intervention (month 3), and at 12 months follow-up after the end of the intervention (month 15). Results: The IG had a significantly reduced number of visits during the 12 months after the intervention: 14.8 (8.5). The CG remained about the same: 18.2 (11.1) (P = .002). Conclusions: Our findings indicate that a 3-month physical activity program linked to community resources is a short-duration, effective and sustainable intervention in inactive patients to decrease rates of PHC visits.

Background There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC). Methods/Design Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people). Intention to treat analysis. Study population: Smokers (n = 3024) aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation – contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage. Control group: usual care. Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ≤ 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36. Discussion The application of a stepped intervention based on the stages of a change model is possible under real and diverse clinical practice conditions, and improves the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline. Trial Registration Clinical Trials.gov Identifier: NCT00125905

Introducción: Los Accidentes de Tráfico (AT) son un problema de salud importante por la mortalidad, morbilidad y discapacidades que originan. Existen tres grupos de mayor riesgo: población de 15-24 años usuarios de motocicletas, población de 18-34 años ocupantes de turismos en carretera y peatones >65 años en zona urbana. En el marco de las actividades preventivas y como un elemento primordial del trabajo de los profesionales de Atención Primaria (AP) se encuentra la educación sanitaria en estilos de vida o comportamientos que afectan directamente al estado de salud. Para la prevención de los AT es importante la educación sanitaria y es responsabilidad de los profesionales sanitarios (PS) efectuar el consejo preventivo en seguridad vial.Objetivos e Hipótesis: Son Objetivos de este trabajo: 1. Determinar nivel de conocimientos y actitudes de los profesionales de la AP sobre consejo preventivo de AT relativo a: Epidemiología (datos de incidencia y/o prevalencía), lesiones más habituales producidas por los AT, utilización de medidas de seguridad activa y pasiva a recomendar en la población, consumo de bebidas alcohólicas, consumo de medicamentos y otras sustancias potencialmente peligrosas en la conducción de vehículos y enfermedades relacionadas con la capacidad de conducción.2. Determinar la factibilidad del consejo preventivo sobre seguridad viaria desde la AP en cuanto a: Grado de responsabilidad de cada PS (médicos generales, pediatras y enfermeras), elementos facilitadores y elementos barrera.Hipótesis: 1. El nivel de conocimiento sobre la prevención de AT es insuficiente para realizar un consejo preventivo. 2. El nivel de conocimiento y la actitud sobre la seguridad vial de los profesionales de la AP es diferente en función de edad, sexo, núcleo familiar, profesión (médico o enfermera), experiencia en servicios de urgencias y experiencia personal en AT y 3. Los profesionales de AP consideran poco factible el consejo preventivo en AT por falta de tiempo.Método:Diseño: El presente trabajo se ha realizado mediante la combinación de metodología cuantitativa y cualitativa. El estudio cuantitativo es descriptivo transversal y el cualitativo mediante la tecnica de los grupos focales. El periodo de realización de ambos estudios fue de Octubre 2000 a Marzo 2001. Ambito: Centros de Atención Primaria de Barcelona ciudad. Sujetos de estudio: médicos (generales y pediatras) y personal de enfermería de AP en Barcelona ciudad. Instrumentos de medida: Encuesta autoadministrada sobre conocimientos y actitudes respecto al consejo preventivo sobre seguridad viaria y análisis de grupos focales. Variables: Según las dos herramientas de trabajo serán: edad, sexo, estado civil, número de hijos, profesión, centro de trabajo, grado de conocimiento sobre consejo preventivo, grado de responsabilidad, elementos facilitadores y elementos barrera (tiempo, incentivos, motivación y nivel de autoconfianza).Resultados:Estudio cuantitativo.Tasa de respuesta al cuestionario de 54,8% (187/341). Respondieron 74,6% mujeres y 25,4% hombres, media de edad 41,3 años (DE 8,3), rango 23-64 [IC 95%: 40,1-42,5] años. Llevaban una media de 11,6 años trabajando (DE 7,6), rango 1-43 años de práctica [IC 95%: 10,5-11,7]. Declaran haber tenido experiencia personal o familiar relacionada con algún AT el 59,9% [IC 95% 52,9-66,9]. La variable principal (puntuación del total del test) mostró una media de 11,3 (IC 95% 10,9-11,7). La puntuación total del test se relacionó de manera inversa y estadísticamente significativa con edad (r=-0,344; r2 = 0,118; pEstudio cualitativo.Se realizaron 4 entrevistas grupales (grupos focales), 3 segmentando según tipo de profesional sanitario y la cuarta con participación de todos los profesionales.Los AT se perciben como grave problema, pero no prioritario. Se identifica una falta significativa de coordinación de esfuerzos para reducir los AT desde diversos ámbitos. El grado de sensibilización de los PS hacia los AT es variable en función de que hayan trabajado en un servicio de urgencias, que hayan tenido experiencias directas con AT o que tengan hijos. Las principales barreras para la viabilidad de su aplicación son: falta de tiempo, formación, información sobre la efectividad de las intervenciones preventivas, falta de recursos y de motivación relacionada con el desconocimiento de la efectividad de estos consejos. Se destacan entre los elementos que podrían facilitar la aplicación de este programa: disponer de información sobre efectividad intervenciones aplicadas, manuales de ayuda, material de apoyo en consulta, sensibilización de los profesionales de AP previa al inicio de la aplicación del programa y coordinación de esfuerzos con otros ámbitos para reforzar la efectividad de este programa. Conclusiones1. Los profesionales sanitarios de AP tienen un nivel de conocimientos intermedio, que precisa de actividades formativas.2. Los PS consideran el consejo preventivo en AT es una actividad importante, pero no prioritaria.3. Las principales barreras para aplicar el consejo preventivo detectadas por los profesionales de AP son: falta de tiempo, ausencia de recursos materiales (educativos y de apoyo), escasa formación y baja motivación.4. Los elementos que facilitarían el consejo preventivo en AT son: Información sobre efectividad de la intervención, material de apoyo en consultas, campañas de sensibilización y aumento de tiempo para esta función.5. Los profesionales sanitarios creen necesario que por parte de la administración sanitaria y las sociedades científicas, se realicen actividades sensibilización entre los PS y de coordinación con otros colectivos implicados., 1. Introduction:Traffic accidents (TA) are a health significant problem due to the mortality, morbility and disabilities they cause. There are three major risk groups: population between 15-24 years old motorbike users, population between 18-24 car drivers, and pedestrians in urban zone older than 65 years. In the frame of the preventive activities, and as a basic work element of Primary Health Care (PHC) Professionals, we could find the health education on lifestyles or behaviors that directly affect the Health Status. Health Education is essential and it is Health Practitioners´ responsibility to give advice in road safety.2. Objectives and hypotheses: The aims of this work are: 1. To assess the level of knowledge and attitudes of PHC Professionals about TA preventive advice relating to: epidemiology (incidence and prevalence), frequent injuries produced by TA, use of active and passive safety measures to be recommend to the general population, alcohol consumption, drugs consumption and other potentially dangerous substances for driving as well as illnesses affecting driving abilities.2. To explore the feasibility of AP preventive advice about road safety on: responsibility of every (HP) (general practitioners, pediatricians, and nurses), facilitator elements and barrier elements. The hypotheses are as follows:1. The level of TA prevention knowledge is not enough to make a preventive advice.2. PHC Professionals knowledge as well as their attitude towards road safety are different depending on age, sex, familiar core, profession (doctor or nurse), experience in emergency services, and personal experience in TA.3. PHC professionals consider the preventive advice non factible due to lack of time.3. MethodDesign: this work has been done with the combination of quantitative and qualitative methodologies. The quantitative study is descri ptive transversal and the qualitative one by focal group's technique. Both studies took place from October 2000 to March 2001.Setting: Primary Attention Centers in the City of Barcelona.Study subjects: Doctors (General Practitioners and Pediatricians) and Nurses in Barcelona. Measure tools: self survey on preventive road safety advice knowledge and attitudes, and analyses of focal groups. Variables: according to working tools they would be: age, sex, civil state, number of children, profession, work center, knowledge level on preventive advice, responsibility grade, facilitator and barrier elements (time, incentives, motivation, and level of self confidence).4. ResultsQuantitative study:Rate of response to the questionnaire of 54.8 % (187/341). Answered by 74.6% women and 25.4% men, average age of 41.3 years old (SD 8.3), ranging 23-64 years old (CI 95%: 40.1-42.5) years. They were taking an average of 11.6 working years (SD 7.6), ranging 1-43 years of practice [CI 95 %: 10.5-11.7]. They declare to have personal or relative experience related to some TA 59,9 % [CI 95 % 52.9-66.9]. The main variable (score of the whole test) showed an average of 11.3 (CI 95 % 10.9-11.7). The total score of the test was connected to age in an inverse and statistically significant way (r = -0.344; r2 = 0.118; p < 0.001) and years of experience (r = -0.194; r2 = 0.038; p = 0.009). The overcoming skills test were connected to the profession of the Doctor (OR 3.7; CI95 % 1.5-9), age group up to 45 years (OR 3.1; CI95 % 1.3-7.6) and being driver (OR 2.9; CI95 % 1.04-8.3).Qualitative studyFour grouped interviews were carried out (focal groups), three segmenting according to type of Health Professional and the fourth one with participation of all professionals.TA are perceived as a serious problem, but not a main priority. It has been identified a significant lack of coordination of efforts to reduce the TA from diverse areas. The level of awareness of the HP towards the TA is changeable depending on having been employed with an Emergency Services dealing directly with TA or those having children on their ownThe main barriers for the viability of its application are: lack of time, training, information about the efficiency of the preventive actions, lack of resources and of motivation related to the ignorance of the efficiency of these advices. The highlighted elements that might ease the application of this program are as follows: to have information about efficiency applied actions, help handbooks, supporting material in surgeries, awareness of PHC professionals before the beginning of the program application, and coordination of efforts with other areas to reinforce the efficiency of this program.5. Conclusions1. PHC professionals have a intermediate level of knowledge, which need formative activities.2. HP consider important the preventive advice in TA, but not as a priority activity.3. The main barriers to apply the preventive advice detected by PA professionals are: lack of time, absence of material resources (educational and supporting), shortage of training, and low motivation.4. The elements that would ease the preventive advice in TA are: Information on intervention efficiency, supporting material in surgeries, awareness campaigns, and increase in time for this function.5. Health Professionals believe is necessary that the Health Authority as well as Scientific Societies are aware of the importance of activities carried out between HP and other involved groups.

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