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

Abstract

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.

FIGURE 1

Study visits and assessments. COPD: chronic obstructive pulmonary disease.

FIGURE 2

Components of the Urban Training intervention.

FIGURE 3

Flow of participants through the trial. ^#: at baseline, three patients did not provide a valid record of physical activity due to technical reasons (e.g. patient entered the swimming pool and spoiled the record); ^¶: reasons for exclusion between baseline and 12 months were spending >3 months per year away from their home address (n=7), mental disability (n=3), severe comorbidity limiting survival at 1 year (n=13) and another severe comorbidity (n=30); ⁺: at the 12-month visit, six (2%) out of 286 patients did not fulfil the criterion of ≥3 days with ≥8 h of wearing time within waking hours.

FIGURE 4

a) Efficacy and b) effectiveness results of Urban Training intervention on steps per day (primary outcome) at 12 months in chronic obstructive pulmonary disease patients. Data are presented as mean±sem at baseline and 12 months.

FIGURE 5

Efficacy of Urban Training intervention on steps per day (primary outcome) at 12 months in chronic obstructive pulmonary disease (COPD) patients according to subgroups based on baseline characteristics. Data are presented as adjusted difference (95% CI) at 12 months between intervention and usual-care groups. Subgroups defined by baseline airflow limitation stages (mild to moderate versus severe to very severe), functional exercise capacity (median 6-min walking distance (6MWD) <500 versus ≥500 m), comorbidity (Charlson index <2 versus ≥2) and physical activity levels (baseline <7100 versus ≥7100 steps per day, cut-off equivalent to being adherent to physical activity recommendations for older adults) [30].