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.
BackgroundThe use of mobile phone apps for improving lifestyles has become generalized in the population, although little is still known about their effectiveness in improving health.ObjectiveWe evaluate the effect of adding an app to standard counseling on increased physical activity (PA) and adherence to the Mediterranean diet, 3 months after implementation.MethodsA randomized, multicenter clinical trial was carried out. A total of 833 participants were recruited in six primary care centers in Spain through random sampling: 415 in the app+counseling group and 418 in the counseling only group. Counseling on PA and the Mediterranean diet was given to both groups. The app+counseling participants additionally received training in the use of an app designed to promote PA and the Mediterranean diet over a 3-month period. PA was measured with the 7-day Physical Activity Recall (PAR) questionnaire and an accelerometer; adherence to the Mediterranean diet was assessed using the Mediterranean Diet Adherence Screener questionnaire.ResultsParticipants were predominantly female in both the app+counseling (249/415, 60.0%) and counseling only (268/418, 64.1%) groups, with a mean age of 51.4 (SD 12.1) and 52.3 (SD 12.0) years, respectively. Leisure-time moderate-to-vigorous physical activity (MVPA) by 7-day PAR increased in the app+counseling (mean 29, 95% CI 5-53 min/week; P=.02) but not in the counseling only group (mean 17.4, 95% CI –18 to 53 min/week; P=.38). No differences in increase of activity were found between the two groups. The accelerometer recorded a decrease in PA after 3 months in both groups: MVPA mean –55.3 (95% CI –75.8 to –34.9) min/week in app+counseling group and mean –30.1 (95% CI –51.8 to –8.4) min/week in counseling only group. Adherence to the Mediterranean diet increased in both groups (8.4% in app+counseling and 10.4% in counseling only group), with an increase in score of 0.42 and 0.53 points, respectively (P<.001), but no difference between groups (P=.86).ConclusionsLeisure-time MVPA increased more in the app+counseling than counseling only group, although no difference was found when comparing the increase between the two groups. Counseling accompanied by printed materials appears to be effective in improving adherence to the Mediterranean diet, although the app does not increase adherence.ClinicalTrialClinicaltrials.gov NCT02016014; https://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/6mnopADbf)
BackgroundNew technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging.Methods/DesignA randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness.DiscussionConfirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health.Trial registrationClinical Trials.gov Identifier: NCT02016014
Background and ObjectivesProlonged sitting time has negative consequences on health, although the population is not well aware of these harmful effects. We explored opinions expressed by primary care patients diagnosed as overweight or moderately obese concerning their time spent sitting, willingness to change, and barriers, facilitators, goals and expectations related to limiting this behaviour.MethodsA descriptive-interpretive qualitative study was carried out at three healthcare centres in Barcelona, Spain, and included 23 patients with overweight or moderate obesity, aged 25 to 65 years, who reported sitting for at least 6 hours a day. Exclusion criteria were inability to sit down or stand up from a chair without help and language barriers that precluded interview participation. Ten in-depth, semi-structured interviews (5 group, 5 individual) were audio recorded from January to July 2012 and transcribed. The interview script included questions about time spent sitting, willingness to change, barriers and facilitators, and the prospect of assistance from primary healthcare professionals. An analysis of thematic content was made using ATLAS.Ti and triangulation of analysts.ResultsThe most frequent sedentary activities were computer use, watching television, and motorized journeys. There was a lack of awareness of the amount of time spent sitting and its negative consequences on health. Barriers to reducing sedentary time included work and family routines, lack of time and willpower, age and sociocultural limitations. Facilitators identified were sociocultural change, free time and active work, and family surroundings. Participants recognized the abilities of health professionals to provide help and advice, and reported a preference for patient-centred or group interventions.ConclusionsFindings from this study have implications for reducing sedentary behaviour. Patient insights were used to design an intervention to reduce sitting time within the frame of the SEDESTACTIV clinical trial.
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