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

Ane Arbillaga-Etxarri, Elena Gimeno-Santos, Anael Barberan-Garcia, Eva Balcells, Marta Benet, Eulàlia Borrell, Nuria Celorrio, Anna Delgado, Carme Jané, Alicia Marin, Carlos Martín-Cantera, Mónica Monteagudo, Nuria Montellà, Laura Muñoz, Pilar Ortega, Diego A Rodríguez, Robert Rodríguez-Roisin, Pere Simonet, Pere Torán-Monserrat, Jaume Torrent-Pallicer, Pere Vall-Casas, Jordi Vilaró, Judith Garcia-Aymerich, Ane Arbillaga-Etxarri, Elena Gimeno-Santos, Anael Barberan-Garcia, Eva Balcells, Marta Benet, Eulàlia Borrell, Nuria Celorrio, Anna Delgado, Carme Jané, Alicia Marin, Carlos Martín-Cantera, Mónica Monteagudo, Nuria Montellà, Laura Muñoz, Pilar Ortega, Diego A Rodríguez, Robert Rodríguez-Roisin, Pere Simonet, Pere Torán-Monserrat, Jaume Torrent-Pallicer, Pere Vall-Casas, Jordi Vilaró, Judith Garcia-Aymerich

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.

Conflict of interest statement

Conflict of interest: A. Arbillaga-Etxarri has nothing to disclose. Conflict of interest: E. Gimeno-Santos has nothing to disclose. Conflict of interest: A. Barberan-Garcia has nothing to disclose. Conflict of interest: E. Balcells has nothing to disclose. Conflict of interest: M. Benet has nothing to disclose. Conflict of interest: E. Borrell has nothing to disclose. Conflict of interest: N. Celorrio has nothing to disclose. Conflict of interest: A. Delgado has nothing to disclose. Conflict of interest: C. Jané has nothing to disclose. Conflict of interest: A. Marin has nothing to disclose. Conflict of interest: C. Martín-Cantera has nothing to disclose. Conflict of interest: M. Monteagudo has nothing to disclose. Conflict of interest: N. Montellà has nothing to disclose. Conflict of interest: L. Muñoz has nothing to disclose. Conflict of interest: P. Ortega has nothing to disclose. Conflict of interest: D.A. Rodríguez has nothing to disclose. Conflict of interest: R. Rodríguez-Roisin reports grants from Almirall and Menarini, personal fees for advisory board work from Boehringer Ingelheim, Pearl Therapeutics and TEVA, personal fees for lecturinf from Novartis and Takeda, during the conduct of the study, all related to COPD. Conflict of interest: P. Simonet reports personal fees for speaking from Menarini, Gebro, Teva, Boehringer, Rovi, AstraZeneca and GSK, outside the submitted work. Conflict of interest: P. Torán-Monserrat has nothing to disclose. Conflict of interest: J. Torrent-Pallicer has nothing to disclose. Conflict of interest: P. Vall-Casas has nothing to disclose. Conflict of interest: J. Vilaró has nothing to disclose. Conflict of interest: J. Garcia-Aymerich reports personal fees for consulting and lecture fees paid to institution from AstraZeneca, personal fees for lecturing from Esteve and Chiesi, outside the submitted work.

Copyright ©ERS 2018.

Figures

FIGURE 1
FIGURE 1
Study visits and assessments. COPD: chronic obstructive pulmonary disease.
FIGURE 2
FIGURE 2
Components of the Urban Training intervention.
FIGURE 3
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
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
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].

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