Any increment in physical activity reduces mortality risk of physically inactive patients: prospective cohort study in primary care.

BACKGROUND: It is unclear how engaging in physical activity after long periods of inactivity provides expected health benefits. AIM: To determine whether physically inactive primary care patients reduce their mortality risk by increasing physical activity, even in low doses. DESIGN AND SETTING: Prospective cohort of 3357 physically inactive patients attending 11 Spanish public primary healthcare centres. METHOD: Change in physical activity was repeatedly measured during patients' participation in the 'Experimental Program for Physical Activity Promotion' clinical trial between 2003 and 2006, using the '7-day Physical Activity Recall'. Mortality to 31 December 2018 (312 deaths) was recorded from national statistics, and survival time from the end of the clinical trial analysed using proportional hazard models. RESULTS: After 46 191 person-years of follow-up, compared with individuals who remained physically inactive, the mortality rates of those who achieved the minimum recommendations of 150-300 min/week of moderate- or 75-150 min/week of vigorous-intensity exercise was reduced by 45% (adjusted hazard ratio [aHR] 0.55; 95% confidence interval [95% CI] = 0.41 to 0.74); those who did not meet these recommendations but increased physical activity in low doses, that is, 50 min/week of moderate physical activity, showed a 31% reduced mortality (aHR 0.69, 95% CI = 0.51 to 0.93); and, those who surpassed the recommendation saw a 49% reduction in mortality (aHR 0.51, 95% CI = 0.32 to 0.81). The inverse association between increased physical activity and mortality follows a continuous curvilinear dose-response relationship. CONCLUSION: Physically inactive primary care patients reduced their risk of mortality by increasing physical activity, even in doses below recommended levels. Greater reduction was achieved through meeting physical activity recommendations or adopting levels of physical activity higher than those recommended.

Cardiorespiratory fitness and development of abdominal obesity.

Both, cardiorespiratory fitness and abdominal obesity are independently associated with developing cardiovascular disease and its risk factors. However, the relationship between both attributes is unclear. We examine the relationship between cardiorespiratory fitness and the risk of developing abdominal obesity, and secondarily, other adiposity measures. Retrospective observational study of a cohort of 1284 sedentary patients, who had participated in a clinical trial of physical activity promotion carried out in Spain (2003-2007). At baseline, they were free of cardiovascular disease, hypertension, diabetes, dyslipidemia and/or abdominal obesity, with an indirect VO2max measurement, were 19-80 years old, 62% women, and had completed the two year follow-up. The exposure factor was cardiorespiratory fitness categorized as high, moderate or low, according to tertiles of VO2max values. The main outcome measure was the risk of developing abdominal obesity, as defined by waist circumference >102 (men) and >88 (women) cm. Secondary outcomes were the risk of developing: general obesity, excess body fat, and their combination ("defined" obesity). At two years, 10.5% of the participants had developed abdominal obesity: 6.1% in the high cardiorespiratory fitness tertile, 9.7% in the moderate tertile (adjusted odds ratio, 1.20; 95% confidence interval 0.68-2.10), and 15.7% in the low tertile (adjusted odds ratio, 2.29; 95% confidence interval 1.34-3.91). Moreover, 2.2% of participants in the high cardiorespiratory fitness tertile developed "defined" obesity as did 5.4% in the low tertile (adjusted odds ratio, 2.90; 95% confidence interval 1.15-7.29). Low cardiorespiratory fitness levels are associated with a higher risk of developing abdominal and "defined" obesity.

Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR / Baseline characteristics and changes in treatment after a period of optimization of the patients included in the study EFICAR

OBJETIVO: Se describen los datos basales de clase y capacidad funcional, comorbilidades, calidad de vida y cambios en la medicación durante la optimización del tratamiento, en pacientes con insuficiencia cardiaca y función sistólica deprimida (ICFSD) incluidos en el estudio EFICAR. DISEÑO: Ensayo clínico aleatorizado multicéntrico. EMPLAZAMIENTO: Siete Centros de Salud. PARTICIPANTES: Ciento cincuenta pacientes con ICFSD; edad 68 ± 10 años, 77% varones. Mediciones: Variables sociodemográficas e índice de Charlson. Se evaluó la calidad de vida y la capacidad funcional Se realizó optimización del tratamiento. RESULTADOS: La etiología principal fue la cardiopatía isquémica (45%). Índice de Charlson global: 2,03 ± 1,05. El 31% ingresaron durante el último año por insuficiencia cardiaca. Fracción de eyección media: 37% ± 8. Clase funcional ii: 89%. Capacidad funcional con prueba de esfuerzo: 6,3 ± 1,6. Test 6 min: 446 ± 78 m. Test de la silla: 13,7 ± 4,4 s. Dinamómetro: 34,53 ± 10,12 kgf y 0,58 ± 0,16 bar. Short Form-36 Health Survey: salud física: 43,3 ± 8,4; salud mental: 50,1 ± 10,6. Minnesota Living with Heart Failure Questionnaire global: 22,8 ± 18,7. Tras optimizar el tratamiento no varió el porcentaje de pacientes ni la dosis media de fármacos analizados. CONCLUSIONES: La mayoría de los sujetos están en clase funcional ii, con capacidad funcional y calidad de vida disminuida e índice de comorbilidad elevado. Un ajuste protocolizado del tratamiento no consigue aumentar la dosis ni el número de pacientes con fármacos eficaces para la insuficiencia cardiaca con función cardiaca deprimida

OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68 ± 10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class ii. The Charlson index was 2.03 ± 1.05. The ejection fraction mean was 37% ± 8, 19% with ejection fraction < 30%. With the stress test 6.3 ± 1.6 mean was reached, with the 6 minutes test 446 ± 78 meters and the chair test 13.7 ± 4.4 seconds. The overall quality of life with ejection fraction was 22.8 ± 18.7 and with the Short Form-36 Health Survey, physical health 43.3 ± 8.4 and mental health 50.1 ± 10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class ii, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function

[Baseline characteristics and changes in treatment after a period of optimization of the patients included in the study EFICAR]. / Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR.

OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68±10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class II. The Charlson index was 2.03±1.05. The ejection fraction mean was 37%±8, 19% with ejection fraction <30%. With the stress test 6.3±1.6 mean was reached, with the 6 minutes test 446±78 meters and the chair test 13.7±4.4 seconds. The overall quality of life with ejection fraction was 22.8±18.7 and with the Short Form-36 Health Survey, physical health 43.3±8.4 and mental health 50.1±10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class II, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function.

Predictors of long-term change of a physical activity promotion programme in primary care.

BACKGROUND: Further research is needed to improve the evidence regarding determinants of physical activity (PA) as a crucial step to plan higher effective intervention strategies. The goal of the present study is to identify socio-demographic and clinical characteristics of primary care (PHC) insufficiently active patients that are associated with longitudinal changes in the level of physical activity. METHODS: Longitudinal analysis of baseline socio-demographic and clinical predictors of physical activity change in insufficiently active PHC patients who participated in a PA-promoting multi-centre randomized clinical trial conducted from October 2003 through March 2006. The primary outcome measure was the self-reported physical activity assessed with the 7-day Physical Activity Recall (PAR), at baseline, 6, 12 and 24 months. Baseline covariates included sex, age, social class, anthropometric measures and other cardiovascular risk factors or associated diseases (Diabetes, HTA, tobacco use, etc.), and stage of readiness to change PA. Generalized linear mixed models were used to estimate longitudinal association of studied variables on PA change over the three follow-up measurements. RESULTS: A total of 3691 patients (85% of the 4317 recruited in the trial) with at least one follow-up measurement were included in the longitudinal analysis. At baseline, analysed patients (mean age: 50.6 years; 64.6% women) devoted 34.7 minutes and 2.36 metabolic equivalent hours per week (MET.h/week) to moderate and vigorous physical activity. Older age, male gender, higher social class, lower BMI, diagnosis of diabetes or hypertension, and measurement season were significant predictors of PA longitudinal change. The effect of baseline readiness to change on PA dose was modified by time, showing a positive gradient in favour of those with more readiness to change that increases significantly at 12 and 24 months (p-value interaction < .0001). CONCLUSIONS: Identified baseline characteristics such as readiness to change and risk factors can guide physicians to prioritize time and intervention efforts for maximizing their impact on insufficiently active PHC patients.

Supervised exercise for acute coronary patients in primary care: a randomized clinical trial.

BACKGROUND: Functional capacity is a prognostic factor for coronary patients; accordingly, they are recommended to walk. OBJECTIVE: To assess whether an exercise program supervised in primary care increases their functional capacity more than unsupervised walking. METHODS: A randomized clinical trial was carried out at eight primary care centres of the Spanish Health Service and involving 97 incident cases of low-risk acute coronary patients, <80 years old, randomly assigned to either an unsupervised walking program (UW group; n = 51) or a 6-month cycle ergometer exercise program with gradually increasing frequency and workload intensity supervised by primary care nurses (SE group; n = 46). The two groups received the same common components of secondary prevention care. Changes in functional capacity were assessed in terms of peak oxygen consumption (VO2peak) during exercise testing measured at baseline and at 7 months by cardiologists blinded to group assignment. RESULTS: Overall, 76% of participants completed the study, 30 in the SE and 44 in the UW. Both groups increased baseline-adjusted VO2peak: 5.56ml/kg per minute in the SE (95% confidence interval [CI] 3.38-7.74) and 1.64ml/kg per minute in the UW (95% CI -0.15 to 3.45). The multivariate-adjusted difference between groups was 4.30ml/kg per minute (95% CI 1.82-6.79; P = 0.001) when analyzing completers and 2.83ml/kg per minute (95% CI 0.61-5.05; P = 0.01) in the intention-to-treat analysis, including all participants with baseline values carried forward for those lost to follow-up. CONCLUSIONS: A cycle ergometer exercise program supervised by primary care nurses increased the functional capacity of coronary patients more than unsupervised walking with a clinically relevant difference.

Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners.

BACKGROUND: We evaluate the effectiveness of a physical activity promotion programme carried out by general practitioners with inactive patients in routine care. METHODS AND FINDINGS: Pragmatic, cluster randomised clinical trial conducted in eleven public primary care centres in Spain. Fifty-six general practitioners (GPs) were randomly assigned to intervention (29) or standard care (27) groups. They assessed the physical activity level of a systematic sample of patients in routine practice and recruited 4317 individuals (2248 intervention and 2069 control) who did not meet minimum physical activity recommendations. Intervention GPs provided advice to all patients and a physical activity prescription to the subgroup attending an additional appointment (30%). A third of these prescriptions were opportunistically repeated. Control GPs provided standard care. Primary outcome measure was the change in self-reported physical activity from baseline to six, 12 and 24 months. Secondary outcomes included cardiorespiratory fitness and health-related quality of life. A total of 3691 patients (85%) were included in the longitudinal analysis and overall trends over the whole 24 month follow-up were significantly better in the intervention group (p<0.01). The greatest differences with the control group were observed at six months (adjusted difference 1.7 MET*hr/wk [95% CI, 0.8 to 2.6], 25 min/wk [95% CI, 11.3 to 38.4], and a 5.3% higher percentage of patients meeting minimum recommendations [95% CI: 2.1% to 8.8%] NNT = 19). These differences were not statistically significant at 12 and 24 months. No differences were found in secondary outcomes. A significant difference was maintained until 24 months in the proportion of patients achieving minimum recommendation in the subgroup that received a repeat prescription (adjusted difference 10.2%, 95% CI 1.5% to 19.4%). CONCLUSIONS: General practitioners are effective at increasing the level of physical activity among their inactive patients during the initial six-months of an intervention but this effect wears off at 12 and 24 months. Only in the subgroup of patients receiving repeat prescriptions of physical activity is the effect maintained in long-term. TRIAL REGISTRATION: clinicaltrials.gov NCT00131079.

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.

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.

Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial.

BACKGROUND: Physical activity promotion is a priority, but contribution of physicians' interventions is unclear. The effectiveness of the PEPAF ("Experimental Program for Physical Activity Promotion"), which was implemented exclusively by physicians in routine primary care from October 2003 to December 2004, was assessed. METHODS: Fifty-six Spanish family physicians were randomized to either the intervention (n = 29) or standard care (n = 27) arm of the trial. The physicians recruited 4317 physically inactive patients (2248 for intervention and 2069 for control protocols) from a systematic sample after assessing their physical activity in routine practice. Intervention physicians provided advice to all patients and a physical activity prescription to the subgroup attending an additional appointment (30%). The main outcome measure was the change in physical activity measured by blinded nurses using the 7-Day Physical Activity Recall. Secondary outcomes included cardiorespiratory fitness and health-related quality of life. RESULTS: At 6 months, intervention patients increased physical activity more than controls (adjusted difference, 18 min/wk [95% confidence interval, 6-31 min/wk]; metabolic equivalent tasks x hours per week, 1.3 [95% CI, 0.4-2.2]). The proportion of the population achieving minimal physical activity recommendations was 3.9% higher in the intervention group (1.2%-6.9%; number needed to treat, 26). No differences were found in secondary outcomes. The effect of intervention was positively modified in subjects older than 50 years (P < or = .01) and in the prescription subgroup (P < .001). CONCLUSIONS: Family physicians were effective for increasing physical activity of primary care patients. Overall clinical effect was small but relevant for population public health. Within the intervention program, clinically relevant effects were seen in patients receiving a physical activity prescription. Trial Registration clinicaltrials.gov Identifier: NCT00131079.

Targeting physical activity promotion in general practice: characteristics of inactive patients and willingness to change.

BACKGROUND: Counselling in routine general practice to promote physical activity (PA) is advocated, but inadequate evidence is available to support this intervention, and its sustainable implementation over time is difficult. OBJECTIVES: To describe the characteristics of physically inactive adults visiting GPs and the factors associated with their willingness to change PA. METHODS: A cross-sectional analysis of 4317 Spanish people aged 20-80 years, selected by systematic sampling among those attending 56 public primary health care practices identified as inactive by their GPs in 2003. PA (7-day PAR), PA stage of change, health-related quality of life (SF-36), cardiovascular risk factors, and social and demographic characteristics were measured. Multivariate mixed effects ordinal logistic models were adjusted to identify factors associated with motivational readiness to change. RESULTS: At least 70% (95% CI: 67.6% to 72.8%) of patients assessed by GPs did not achieve minimal PA recommendations. In addition, 85% (95% CI: 83% to 86.3%) had at least an additional cardiovascular risk factor. Only 30% (95% CI: 25.8% to 33.5%) were prepared for or attempting a change. A younger age; retirement or work at home; higher education and social class levels; obesity; and hypertension were associated with a higher motivational readiness to change (p < 0.05). CONCLUSION: The overburden that would result from counselling such a high proportion of inactive primary care patients justifies a targeted strategy for PA promotion in family practice. Selection of a target population based on readiness to change, the combination of risk factors and socio-demographic characteristics of patients is suggested in order to prioritise promotion efforts.