Long-term efficacy and effectiveness of a behavioural and community-based exercise intervention (Urban Training) to increase physical activity in patients with COPD: a randomised controlled trial.

There is a need to increase and maintain physical activity in patients with chronic obstructive pulmonary disease (COPD). We assessed 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in COPD patients.This randomised controlled trial (NCT01897298) allocated 407 COPD patients from primary and hospital settings 1:1 to usual care (n=205) or Urban Training (n=202). Urban Training consisted of a baseline motivational interview, advice to walk on urban trails designed for COPD patients in outdoor public spaces and other optional components for feedback, motivation, information and support (pedometer, calendar, physical activity brochure, website, phone text messages, walking groups and a phone number). The primary outcome was 12-month change in steps·day-1 measured by accelerometer.Efficacy analysis (with per-protocol analysis set, n=233 classified as adherent to the assigned intervention) showed adjusted (95% CI) 12-month difference +957 (184-1731) steps·day-1 between Urban Training and usual care. Effectiveness analysis (with intention-to-treat analysis set, n=280 patients completing the study at 12 months including unwilling and self-reported non-adherent patients) showed no differences between groups. Leg muscle pain during walks was more frequently reported in Urban Training than usual care, without differences in any of the other adverse events.Urban Training, combining behavioural strategies with unsupervised outdoor walking, was efficacious in increasing physical activity after 12 months in COPD patients, with few safety concerns. However, it was ineffective in the full population including unwilling and self-reported non-adherent patients.

Asymptomatic peripheral arterial disease in type 2 diabetes patients: a 10-year follow-up study of the utility of the ankle brachial index as a prognostic marker of cardiovascular disease.

BACKGROUND: Our aim was to evaluate the relationship between asymptomatic peripheral arterial disease, diagnosed only by the ankle brachial index (ABI), and cardiovascular disease (CVD) after a 10-year follow-up period in patients with type 2 diabetes. METHODS: In 1996, the ankle brachial index was measured in 262 patients with type 2 diabetes. During the 10-year follow-up period (mean follow-up time, 7.7 years), all nonfatal cardiovascular events and mortality were recorded. RESULTS: A total of 52 patients died during the follow-up time. The mortality of the patients with normal (0.91-1.24) and abnormal ABI (≤0.90) at the beginning of the study was 16.8% and 52.8%, respectively (p < 0.05). The incidence rate of fatal and nonfatal CVD was 26.9 (95% confidence intervals [CI]: 20.7-37.3) for the patients with a normal baseline ABI and 81.9 (95% CI: 50.9-131.8) for those with an abnormal baseline ABI. An abnormal baseline ABI was associated with a greater risk of CVD (hazard ratio = 2.32; 95% CI: 1.27-4.22). CONCLUSION: ABI values ≤0.9 in patients with type 2 diabetes mellitus and no history of intermittent vascular claudication or rest pain were associated with a higher risk of coronary or cerebrovascular morbidity and mortality.

Incidence and risk factors of exacerbations among COPD patients in primary health care: APMPOC study.

BACKGROUND: Worldwide, chronic obstructive pulmonary disease (COPD) is the fourth cause of death. Exacerbations have a negative impact on the prognosis of COPD and the frequency and severity of these episodes are associated with a higher patient mortality. Exacerbations are the first cause of decompensation, hospital admission and death in COPD. The incidence of exacerbations has mainly been estimated in populations of patients with moderate-severe COPD requiring hospital care. However, little is known regarding the epidemiology of exacerbations in patients with less severe COPD forms. It is therefore possible that a high number of these less severe forms of exacerbations are underdiagnosed and may, in the long-term, have certain prognostic importance for the COPD evolution. The aim of this study was to know the incidence and risk factors associated with exacerbations in patients with COPD in primary care. METHODS AND DESIGN: A prospective, observational, 3-phase, multicentre study will be performed involving: baseline evaluation, follow up and final evaluation. A total of 685 smokers or ex-smokers from 40 to 80 years of age with COPD, without acute respiratory disease or any other long-term respiratory disease will be randomly selected among the population assigned to 21 primary care centres. The diagnosis of COPD and its severity will be confirmed by spirometry. Information regarding the baseline situation, quality of life and exposure to contaminants or other factors potentially related to exacerbations will be collected. A group of 354 patients with confirmed COPD of varying severity will be followed for one year through monthly telephone calls and daily reporting of symptoms with the aim of detecting all the exacerbations which occur. These patients will be evaluated again at the end of the study and the incidence of exacerbations and associated relative risks will be estimated by negative binomial regression. DISCUSSION: The results will be relevant to provide knowledge about natural history of the initial phases of the COPD and the impact and incidence of the exacerbations on the patients with mild-moderate forms of the disease. These data may be important to know the milder forms of exacerbation which are often silent or very little expressed clinically.