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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
1,2,3, 4
, Elena Gimeno-Santos
1,2,3,5,6
,
Anael Barberan-Garcia
5,6
, Eva Balcells
2,7,8
,MartaBenet
1,2,3
, Eulàlia Borrell
9,10,11
,
Nuria Celorrio
12
, Anna Delgado
1,2,3
, Carme Jané
13
, Alicia Marin
8,14
,
Carlos Martín-Cantera
10,13,15
, Mónica Monteagudo
10,15
, Nuria Montellà
9,10,11
,
Laura Muñoz
16
,PilarOrtega
17
, Diego A. Rodríguez
2,7,8
, Robert Rodríguez-Roisin
6
,
Pere Simonet
10,18,19
, Pere Torán-Monserrat
10,11
, Jaume Torrent-Pallicer
1,2,3
,
Pere Vall-Casas
20
, Jordi Vilaró
21
and Judith Garcia-Aymerich
1,2,3
@ERSpublications
Urban Training in COPD increased physical activity after 12 months but not in self-reported non-
adherent patients http://ow.ly/dc2C30lnAEs
Cite this article as: Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, et al. 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. Eur Respir J 2018; 52: 1800063
[https://doi.org/10.1183/13993003.00063-2018].
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.
This article has supplementary material available from erj.ersjournals.com
Urban Training is trademark registered in Spain (ref. 3502702/9).
This study is registered at ClinicalTrials.gov with identifier number NCT01897298. The corresponding author can provide,
upon request, individual participant data that underlie the results reported in this article (except variables, if any, that may
allow identification of patients), after applying necessary measures to guarantee that no individual is identified or identifiable.
Received: Jan 11 2018 | Accepted after revision: Aug 06 2018
Copyright ©ERS 2018. This version is distributed under the terms of the Creative Commons Attribution Non-
Commercial Licence 4.0.
https://doi.org/10.1183/13993003.00063-2018 Eur Respir J 2018; 52: 1800063
|
ORIGINAL ARTICLE
COPD
Affiliations:
1
ISGlobal, Barcelona, Spain.
2
Pompeu Fabra University (UPF), Barcelona, Spain.
3
CIBER
Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
4
Physical Activity and Sports Sciences, Faculty
of Psychology and Education, University of Deusto, Donostia-San Sebastián, Spain.
5
Respiratory Clinic
Institute, Hospital Clinic of Barcelona, Barcelona, Spain.
6
Institut d’Investigacions Biomèdiques August Pi i
Sunyer (IDIBAPS)-Hospital Clínic, University of Barcelona, Barcelona, Spain.
7
Pneumology Dept, Hospital del
Mar, Institut Hospital del Mar d’Investigacions Mèdiques (IMIM), Barcelona, Spain.
8
CIBER Respiratory
Diseases (CIBERES), Bunyola, Spain.
9
Sant Roc Primary Healthcare Centre, Institut Català de la Salut (ICS),
Badalona, Spain.
10
Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol),
Barcelona, Spain.
11
Institute for Health Science Research Germans Trias i Pujol (IGTP), Badalona, Spain.
12
Hospital de Viladecans, Viladecans, Spain.
13
Passeig de Sant Joan Primary Healthcare Centre, Institut
Català de la Salut (ICS), Barcelona, Spain.
14
Pneumology Dept, Hospital Germans Trias i Pujol, Badalona,
Spain.
15
Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain.
16
Agency for Health
Quality and Assessment of Catalonia (AQuAS), Barcelona, Spain.
17
Pneumology Dept, Hospital de Mataró,
Mataró, Barcelona, Spain.
18
Viladecans 2 Primary Healthcare Centre, Institut Català de la Salut (ICS),
Viladecans, Spain.
19
University of Barcelona, Barcelona, Spain.
20
Universitat Internacional de Catalunya (UIC),
Barcelona, Spain.
21
FCS Blanquerna, Global Research on Wellbeing (GRoW), Ramon Llull University,
Barcelona, Spain.
Correspondence: Judith Garcia-Aymerich, Barcelona Institute of Global Health (ISGlobal), Dr Aiguader 88,
08003 Barcelona, Spain. E-mail: judith.garcia@isglobal.org
Introduction
Patients with chronic obstructive pulmonary disease (COPD) are substantially less active than their healthy
peers [1] and this inactivity has been consistently related to a worse prognosis of the disease [2]. Thus,
helping patients to adopt a more active lifestyle is a major goal in COPD management. Unfortunately, how
to produce and maintain such behavioural change remains a challenge [3, 4].
Based on the beneficial effects of behavioural strategies on changing physical activity in patients with
chronic diseases [5], recent COPD studies have focused on these kinds of interventions. Some of them,
including physical activity counselling, pedometers or telecoaching (by computer or mobile technology)
have reported increases in physical activity in the short term (⩽4 months) [6–8]. However, few studies
followed patients for ⩾1 year [6, 9–11] and only one of them showed a sustained increase in physical
activity, which was limited to a subset of patients [9]. Thus, one of the main difficulties of interventions to
modify physical activity in COPD patients the achievement of a more prolonged long-term effect.
Given that currently available interventions are based mostly on patients’individual factors (biological and
psychological), we argue that customising the interventions to patients’interpersonal (social support and
cultural practices) and environmental (social, built and natural) determinants of physical activity [12]
could help to maintain the increase in physical activity in the long term. Indeed, a report from the World
Health Organization [13] suggests that interventions adapted to the local context and/or using existing
social support and community structures are the most successful. In COPD, patients who live with others,
walk the dog, take care of grandchildren or have an active partner have higher physical activity levels than
those who do not, regardless of COPD severity and other individual characteristics [14–16], which
suggests that interpersonal and environmental factors are key factors to include in future interventions.
Based on these premises we designed an intervention (Urban Training) consisting of motivational
interviews, availability of outdoor walking trails specifically designed for exercise training of COPD
patients [17] and other support components. We hypothesised that Urban Training could encourage
COPD patients to increase and maintain their walking activity in the long term, because walking in public
spaces is an extended cultural practice well integrated into the daily lifestyle of our COPD patients (elderly
inhabitants of Mediterranean cities) [18].
We assessed the efficacy and effectiveness of the Urban Training intervention on physical activity level
after 12 months of follow-up in patients with COPD. Secondary outcomes included severe COPD
exacerbations, functional exercise capacity, body composition, health-related quality of life, anxiety and
depression.
Methods
Study patients
Details on patient recruitment, randomisation and blinding are provided in online supplementary table S1.
Briefly, we selected all subjects with a diagnosis of COPD according to the American Thoracic Society/
European Respiratory Society recommendations (post-bronchodilator forced expiratory volume in 1 s
(FEV1) to forced vital capacity (FVC) ratio <0.70) [19] who were seen in any of the participating 33
primary care and five hospital health centres from five Catalan seaside municipalities. We excluded
patients with severe or life-threatening comorbidities, or those clinically unstable. The ethics committees of
https://doi.org/10.1183/13993003.00063-2018 2
COPD | A. ARBILLAGA-ETXARRI ET AL.
all participating institutions approved the study, along with the request for complete information
exemption from patients, and all participants provided written informed consent.
Study design and interventions
This is a prospective, multicentre, parallel-group, randomised controlled trial registered at clinicaltrials.gov
(NCT01897298) and reported according to the 2010 CONSORT statement [20] and its extension for
non-pharmacological interventions [21]. Patients were allocated 1:1 to the Urban Training intervention or
usual-care groups using random block sizes of six, eight and 10. The study consisted of four visits (figure 1):
enrolment and baseline data collection; additional baseline data collection, randomisation and intervention
1 week later; 12-month data collection; and additional 12-month data collection 1 week thereafter.
Both groups received the usual standardised pharmacological and/or non-pharmacological treatment for
COPD, including pulmonary rehabilitation, at the discretion of their physician and without any
intervention by the research team.
Patients in the usual-care group were provided with general health counselling and the European Lung
Foundation (ELF) information brochure “Living an active life with COPD”[22], which recommends
⩾30 min moderate physical activity ⩾5 days per week.
The Urban Training intervention consisted of the following six components (figure 2), detailed in the
online supplementary material. 1) At baseline, a respiratory physiotherapist adequately trained in
behavioural strategies used motivational interviewing techniques [23], integrated with a stage-matched
approach [24], for a maximum of 1 h. The interview was centred on empathy, reflective listening and
affirmation, and addressed patients’resistance (personal difficulties, barriers and limitations) to eliciting
behavioural change. Information on the remaining components of the intervention was provided during
this interview. During the follow-up period, the physiotherapist administered up to four phone calls lasting
5–10 min to maintain motivation, depending on patients’self-efficacy and stage of change. 2) Participants
received a dossier containing various maps of Urban Training walking trails, previously validated [17],
according to their mobility options and preferences. Concisely, trails of different intensities (low, moderate
or high, combining urban elements of varying intensity (stairs, ramps and types of surfacing)) were
Visit 2Visit 1 Visit 3 Visit 4
1
week
12 months
All
subjects
Urban Training
intervention
Urban Training
intervention
Urban Training
intervention
Usual care
Randomisation
Informed consent
Baseline data collection (1):
• Sociodemographics
• Smoking status
• Dyspnoea
• Health-related quality of
life
• Anxiety and depression
symptoms
• Cognitive impairment
• Exercise capacity
• Body composition
• Lung function
• Comorbidities
• Pharmacotherapy
• COPD exacerbations
• Physical activity
(accelerometer delivery)
Baseline data collection (2):
• Physical activity
(accelerometer collection)
• Physical activity experience
Randomisation
Intervention administration
12-month data collection (1):
• Sociodemographics
• Smoking status
• Dyspnoea
• Health-related quality of life
• Anxiety and depression
symptoms
• Cognitive impairment
• Exercise capacity
• Body composition
• Lung function
• Comorbidities
• Pharmacotherapy
• COPD exacerbations
• Physical activity
(accelerometer delivery)
12-month data collection (2):
• Physical activity
(accelerometer collection)
• Physical activity experience
• Satisfaction
• Adverse events
Usual care Usual care
1
week
FIGURE 1 Study visits and assessments. COPD: chronic obstructive pulmonary disease.
https://doi.org/10.1183/13993003.00063-2018 3
COPD | A. ARBILLAGA-ETXARRI ET AL.
available in several walkable public spaces (boulevards, beaches and parks) of the five municipalities. The
physiotherapist provided a complete explanation of trails characteristics and instructed patients to train
following the FITT (frequency, intensity, time and type) principle [25]. Each patient was advised to start
with a trail of intensity appropriate to his/her baseline dyspnoea and 6-min walking distance (6MWD),
and instructed how to increase progressively the volume (number of walks per day on the same trail) and/
or the intensity of the trails during the following 12 months according to their symptoms and motivation
(online supplementary figure S1). In all cases, the instructions were to walk at least one trail per day
⩾5 days per week, at a pace reaching a dyspnoea Borg scale score of 4–6 [26]. 3) Patients were provided
with both a pedometer and a personalised calendar to monitor their physical activity and maintain
motivation. 4) Patients received the same ELF information brochure as the usual-care group and the link
to the project website (www.entrenament-urba.cat/). They were requested to provide a personal cell phone
number where they would receive phone text messages every 2 weeks with educational or motivational
messages. 5) Once per month during the follow-up period, patients could join a walking group for walking
a trail accompanied by an experienced physical activity trainer. 6) Patients were given a phone number to
contact the physiotherapists for any questions during follow-up. Of note, the Urban Training intervention
was proposed as a supplement to the physical activities of daily life and in no case as a substitute activity.
Procedures
Full details and references on study procedures and quality control are available in the online
supplementary material. Briefly, at baseline and 12 months we obtained the following data from all
patients using standardised procedures. 1) Sociodemographic variables, smoking status, modified Medical
Research Council dyspnoea scale, Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT),
Hospital Anxiety and Depression (HAD) scale and cognitive impairment (using phototesting)
Urban Training
1 Motivational interviewing
¿Podria indicarme, del 0 al 10, cόmo de importante es para usted salir a caminar a diario?
2 Urban Training walking trails 3 Pedometer and calendar
4 Brochure, website and phone text messages 5 Walking group 6 Phone number
012345678910
Calendaris creat per Elena Gimeno, Judith Garcia Aymerich i Ane Arbillaga. Per als permisos de reproducció contactar amb: entrenament_urba@creal.cat
:: No surti sol,
camini acompanyat ::
:: Pujar escales és
saludable. Agafa ritme
i puja a poc a poc ::
:: Cuando camine, lleve
siempre encima la
medicación de rescate ::
_DILLUNS _DIMARTS _DIMECRES _DIJOUS _DIVENDRES _DISSABTE _DIUMENGE
123456
UNA VOLTA
AL CIRCUIT,
MÍNIM
7 8 910111213
CAMINADA
EN GRUP
Mataró
CAMINADA
EN GRUP
Badalona
CAMINADA
EN GRUP
Viladecans /
Gavá
CAMINADA
EN GRUP
Barcelona
BONA
DIADA CAMINA
AL MENOS,
20 minutos
14 15 16 17 18 19 20
INTENTA
CONTROLAR
EL AHOGO
CAMINADA
EN GRUP
Barcelona
21 22 23 24 25 26 27
HO FAS MOLT
MOLT BÉ,
CONTINUA!
28 29 30
NOTES:
Setembre 2015
1/4
www.european-lung-foundation.org
FIGURE 2 Components of the Urban Training intervention.
https://doi.org/10.1183/13993003.00063-2018 4
COPD | A. ARBILLAGA-ETXARRI ET AL.
(interviewer-administered questionnaire); 2) 6-min walk test; 3) weight, height, body mass index (BMI)
and fat-free mass index (FFMI) (physical examination and bioelectrical impedance); 4) FEV1and FVC
(pre- and post-bronchodilator spirometry); 5) comorbidities, pharmacological therapy and the number
and severity of COPD exacerbations in the previous 12 months; 6) physical activity (Dynaport
accelerometer; McRoberts BV, The Hague, The Netherlands), previously validated for COPD [27, 28]. A
valid physical activity measurement was defined as ⩾3 days with ⩾8 h of wearing time within waking
hours [29]; compliance with the accelerometer was excellent (at baseline all patients fulfilled this criterion,
median (range) wear was 7 (3–7) days, and recording time was 14.9 (11.1–15.0) h, of 15 h maximum from
07:00 h to 22:00 h); at the final visit six (2%) out of 286 patients did not fulfil the criterion of wearing
time per day and, consequently, were excluded; among included patients, median (range) wear was 7 (4–7)
days and recording time was 14.8 (10.2–15) h; all patients included at least one weekend day both at
baseline and final visit); and 7) physical activity experience (Clinical-PROactive Physical Activity
(C-PPAC)). Additionally, at 12 months, patients answered a questionnaire about satisfaction with the study
components and any potential adverse events experienced during or after walks in the previous 12 months.
Finally, the physiotherapists administering both interventions noted down patients’spontaneous report of
unwillingness to follow the instructions (e.g. walking ⩾5 days per week ⩾30 min·day
−1
in the usual-care
group or walking the Urban Training trails in the Urban Training group) at the baseline visit, as well as
spontaneous reports of non-adherence (i.e. not having followed the instructions) at the 12-month visit.
Study outcomes
The primary outcome was the change in number of steps per day from baseline to 12-month follow-up.
Secondary outcomes were having any severe COPD exacerbation (leading to hospital or emergency-room
admission) during the 12-month follow-up and the 12-month changes in 6MWD, BMI, FFMI, CAT and
CCQ total scores, and HAD-anxiety and -depression scores. Exploratory outcomes were the 12-month
changes in phototest score, and total, amount and difficulty C-PPAC scores.
Statistical analysis
To detect a difference of 775 steps·day
−1
(primary outcome) between groups (based on previous research
about the effects of behavioural interventions in the elderly) [30], with a two-sided α=0.05 and a power of
80%, assuming a standard deviation of 3000 steps·day
−1
and a correlation between baseline and final steps
⩾0.7 (based on authors’data in COPD patients), a sample size of 142 patients per group was necessary. To
account for a 30% dropout rate during follow-up, we planned to recruit 202 participants per group (404 in
total).
Prespecified efficacy and effectiveness were analysed using per-protocol and intention-to-treat (ITT)
analysis sets, respectively. Briefly, ITT was defined as all randomised patients who completed the study at
12 months and provided a valid record of physical activity, while per-protocol was the subset of ITT who
were classified as adherent to their corresponding intervention. Adherence was obtained from the
interviews. We classified as “non-adherent”patients who 1) spontaneously reported at baseline that they
were unwilling to follow any of the instructions; or 2) spontaneously reported at the 12-month visit that
they had not been adherent to the study protocol (see the Procedures section). Remaining patients were
labelled as “adherent”. To test effectiveness, we built linear or logistic regression models, using the change
from baseline to 12-month follow-up as the outcome, the intervention group as the main exposure
variable and baseline levels of the corresponding outcome as a covariate (to account for individual
differences in baseline levels). In efficacy analysis, we adjusted additionally for the variables related to
adherence, since previous literature has shown that this adjustment may reduce the selection bias produced
by a differential distribution of the reasons that moved participants to be adherent [31].
Post hoc analyses included stratification of efficacy results according to subgroups defined by baseline
patient characteristics (online supplementary material). All analyses were redone using repeated measures
ANOVA instead of linear regression. Safety analysis set included patients answering the adverse events
questions at 12 months. All analyses were conducted with Stata 14.0 (StataCorp, College Station, TX,
USA).
Results
Between 30 October 2013 and 29 January 2016, 552 stable COPD patients were assessed for eligibility and
407 patients underwent randomisation and received the corresponding intervention (figure 3, online
supplementary table S2). 280 patients (69% of the initial study population) completed the final visit and
constituted the ITT analysis set (online supplementary table S3). These patients had higher physical
activity and functional exercise capacity levels at baseline than those who did not participate in the final
visit, both in the usual care and Urban Training group (online supplementary tables S3 and S4). Among
followed patients, 233 patients (83% of the ITT) did not report unwillingness or non-adherence to the
https://doi.org/10.1183/13993003.00063-2018 5
COPD | A. ARBILLAGA-ETXARRI ET AL.
corresponding intervention and accordingly constituted the per-protocol analysis set. Patients who
spontaneously reported unwillingness or non-adherence to the corresponding intervention had lower
FEV1/FVC ratio, were most often current smokers, had diabetes in a higher proportion and showed higher
values in the HAD-depression score than the rest of the patients (online supplementary table S5).
Baseline characteristics were similar in the per-protocol and ITT analysis sets and between two
intervention groups (tables 1–3). Patients in the per-protocol analysis set were mostly male (88%), mean
±SD age 69±8 years, had mild-to-very severe COPD (FEV158±17% predicted), preserved functional
exercise capacity (6MWD 505±81 m) and walked a mean±SD 8039±3964 steps·day
−1
.
After 12 months, according to the per-protocol analysis set (efficacy analysis), patients in the usual-care
group had not changed their physical activity, whereas those in the Urban Training group increased it by
816 steps·day
−1
(figure 4 and table 2). In the analysis adjusted by factors independently related to
adherence (FEV1/FVC ratio, smoking, diabetes and HAD-depression score; online supplementary table S6)
and steps at baseline, the adjusted difference in steps between the Urban Training and usual-care groups
was 957 (95% CI 184–1731) steps·day
−1
(figure 4 and table 2). There were no differences between
intervention groups in any of the secondary outcomes or in cognitive impairment (exploratory outcome)
(table 2). Positive changes (statistically significant better values) of physical activity experience were
observed in the intervention group for the total, amount and difficulty scores. Stratification of efficacy
results showed no significant differences between groups (figure 5). The adjusted difference at 12 months
was 959 (−72–1989) steps·day
−1
for patients with mild-to-moderate COPD and 383 (−860–1626)
steps·day
−1
for patients with severe-to-very severe COPD. Patients with higher physical activity levels at
Randomised (n=407)
Allocated to usual care (n=205)
Included in the intention-to-treat analysis (n=148)
Included in the per-protocol analysis (n=145)
Allocated to intervention (n=202)
Included in the intention-to-treat analysis (n=132)
Included in the per-protocol analysis (n=88)
Invalid activity monitor
data+ (n=1)
Assessed for eligibility (n=552)
Ineligible (n=142)
79 Exclusion criteria
56 Declined to participate
7 Untraced
Participating at 12 months (n=137)Participating at 12 months (n=149)
Not participating at 12
month visit (n=56)
20 Withdrew
25 Exclusion criteria¶
1 Died during trial
10 Untraced
Not participating at 12
month visit (n=65)
28 Withdrew
28 Exclusion criteria¶
3 Died during trial
6 Untraced
Invalid activity monitor
data# (n=3)
Participating at baseline visit (n=410)
Invalid activity monitor
data+ (n=5)
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.
https://doi.org/10.1183/13993003.00063-2018 6
COPD | A. ARBILLAGA-ETXARRI ET AL.
baseline had higher increase during follow-up (adjusted difference in steps 1268 (158–2379) steps·day
−1
versus 704 (−429–1837) steps·day
−1
), although there was no sign of statistical interaction.
After 12 months, in the ITT analysis set (effectiveness analysis), there were no differences between
intervention groups in any of the primary, secondary or exploratory outcomes (figure 4 and table 3).
Analyses with repeated measures ANOVA provided very similar results.
Patients in the Urban Training group reported higher frequency of lower extremity muscle pain during
walks than patients in the usual care group (38 versus 25%, p=0.031) without differences in any of the
remaining adverse events (table 4).
Of the 132 patients of the intervention group participating in the follow-up visit, 70%, 87% and 90% used
the trails maps, calendars and pedometers, respectively; 31% participated at least once in the walking
groups; 41% contacted the researchers via phone during follow-up; and 2% visited the study website. At
the 12-month visit, 65% of patients delivered the calendars, and the mean±SD fulfilled months was 9
±4 months. Satisfaction with the study and study staff was very high (mean satisfaction ⩾9 in a score
ranging from 0 to 10) both in the usual-care and Urban Training groups (online supplementary table S7).
Satisfaction with the study components in the Urban Training group was high or very high: 9.1±1.6 for
trail maps, 9.1±1.7 for calendars, 9.0±1.8 for pedometers, 7.5±2.8 for walking groups, 9.4±1.0 for phone
text messages, 9.5±1.4 for study phoneline and 8.7±2.3 for study website (online supplementary table S7).
Discussion
This randomised controlled trial showed that the Urban Training intervention is more efficacious than
usual care in increasing physical activity after 12 months in patients with COPD, with few safety concerns.
TABLE 1 Baseline characteristics of per-protocol and intention-to-treat analysis sets
Per-protocol analysis set
#
ITT analysis set
#
Usual care Urban
Training
All Usual care Urban
Training
All
Subjects n 145 88 233 148 132 280
Age years 69±8 69±9 69±8 69±8 68±9 69±8
Female/male 17 (12)/128
(88)
12 (14)/76
(86)
29 (12)/204
(88)
18 (12)/130
(88)
18 (14)/114
(86)
36 (13)/244
(87)
Active smoker 29 (20) 20 (22) 49 (21) 30 (20) 34 (26) 64 (23)
Low socioeconomic status
¶
105 (73) 64 (73) 169 (73) 107 (73) 93 (71) 200 (72)
Active worker 16 (12) 13 (15) 29 (13) 16 (11) 19 (15) 35 (13)
Dyspnoea mMRC grade (0–4) 1±1 1±1 1±1 1±1 1±1 1±1
Post-bronchodilator FEV1%pred 58±18 57±16 58±17 58±18 56±17 57±17
Post-bronchodilator FEV1/FVC ratio 0.55±0.12 0.54±0.10 0.54±0.12 0.55±0.12 0.53±0.11 0.54±0.12
Airflow limitation
+
mild/moderate/severe/very
severe %
10/55/30/5 8/57/31/4 9/55/31/5 10/54/30/6 9/51/32/8 10/53/31/6
GOLD 2017 assessment
+
(A/B/C/D) % 37/44/7/12 35/52/0/13 36/47/4/13 36/44/7/13 31/53/3/13 34/48/5/13
Cardiovascular disease
§
88 (61) 52 (60) 140 (60) 90 (61) 81 (62) 171 (61)
Diabetes mellitus
§
37 (26) 25 (29) 62 (27) 38 (26) 44 (34) 82 (29)
Musculoskeletal diseases
§
55 (38) 30 (34) 85 (37) 56 (38) 51 (39) 107 (38)
Charlson index 2(1–3) 1 (1–2) 2 (1–3) 2 (1–3) 2 (1–3) 2 (1–3)
Inhaled corticosteroids (alone or in combination) 81 (57) 47 (55) 128 (56) 82 (57) 68 (53) 150 (55)
Long-acting bronchodilators (LAMA or LABA, alone
or in combination)
113 (80) 73 (86) 186 (82) 116 (80) 109 (85) 225 (82)
Pulmonary rehabilitation at baseline 6 (4) 5 (6) 11 (5) 6 (4) 6 (5) 12 (4)
Pulmonary rehabilitation during follow-up 6 (4) 3 (3) 9 (4) 6 (4) 6 (5) 12 (4)
Data are presented as n, mean±SD, n (%) or median (interquartile range). ITT: intention-to-treat; mMRC: modified Medical Research Council;
FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; LAMA: long-
acting muscarinic antagonist; LABA: long-acting β-agonist.
#
: some variables have missing values, as follows. Per-protocol analysis set:
socioeconomic status (n=1) active worker (n=10), GOLD 2017 assessment (n=2), cardiovascular disease, diabetes and musculoskeletal disease
(n=1), Charlson index (n=1) and inhaled corticosteroids and long-acting bronchodilators (n=6); ITT analysis set: socioeconomic status (n=2),
active worker (n=11), GOLD 2017 assessment (n=3), cardiovascular disease, diabetes and musculoskeletal disease (n=1), Charlson index (n=1)
and inhaled corticosteroids and long-acting bronchodilators (n=6);
¶
: UK National Statistics Socio-economic Classification III, IV or V;
+
: chronic
obstructive pulmonary disease severity mild (FEV1⩾80% pred), moderate (FEV150–79% pred), severe FEV1(30–49% pred), very severe (FEV1
<30% pred) and A (low risk, low symptom burden), B (low risk, high symptom burden), C (high risk, low symptom burden), D (high risk, high
symptom burden);
§
: cardiovascular disease (International Classification of Diseases, 10th revision (ICD-10) I00–I99), diabetes mellitus (ICD-10
E10–E14), musculoskeletal diseases (ICD-10 M00–M99).
https://doi.org/10.1183/13993003.00063-2018 7
COPD | A. ARBILLAGA-ETXARRI ET AL.
However, the intervention was not effective according to results with the ITT analysis set, suggesting that
it improves physical activity only in willing, adherent patients. No effect of the intervention was found on
severe COPD exacerbations, functional exercise capacity, body composition, health-related quality of life,
anxiety or depression, in either analysis approach.
The main finding of this study is that the Urban Training intervention increased physical activity in
COPD patients 1) at long-term (after 12 months) and 2) in a large scale of magnitude. Most studies
testing the effects of behavioural physical activity interventions in COPD patients have successfully
resulted in positive effects only at short-term (≈3 months) [6, 7], and only one reported a long-term
increase, which was restricted to a post hoc subgroup analysis [9]. Examination of the content of previous
and current successful physical activity interventions allows us to hypothesise that the combination of
motivational interviews, pedometers and diaries/calendars may be key for the long-term effect. The
≈900 steps·day
−1
increase observed in the Urban Training group lies within the defined limits of the
minimal important difference in COPD patients (between 600 and 1100 steps·day
−1
) [32] and is greater
than the 255 steps·day
−1
change observed in the long-term physical activity COPD trial referred to above
and the mean 808 steps·day
−1
change identified in a review of pedometer-based physical activity
interventions in older adults (including follow-ups between 2 weeks and 23 months) [30]. Our contention
is that customising walking trails to patients’individual (e.g. exercise capacity and motivation),
interpersonal (e.g. social support and cultural habit of walking) and environmental factors (e.g. lack of
steep stairs in walking trails and home proximity or bus access to them) may have contributed to the
long-term duration and large magnitude of the intervention effect. Therefore, Urban Training appears to
be an attractive intervention potentially feasible due to its simplicity and reduced burden.
Potential harms of the Urban Training intervention need to be discussed. First, patients in the Urban
Training group reported lower-extremity muscle pain in a higher proportion than patients in the
TABLE 2 Efficacy results (per-protocol analysis set) of Urban Training intervention at 12 months in chronic obstructive
pulmonary disease (COPD) patients
Usual care
#
Urban Training
#
Adjusted difference
(95% CI) at 12 months
¶
Baseline 12 months Baseline 12 months
Subjects n 145 88
Primary outcome
Steps per day 7846±3845 7911±3830 8355±4177 9171±4704
+
957 (184–1731)
§
Secondary outcomes
Any severe COPD exacerbation in previous 12 months % 14 16
+
515
+
0.15 (−0.7–1)
6MWD m 503±79 496±86
+
509±83 502±97 3.6 (−6.9–14.2)
BMI kg·m
−2
28.2±4.5 28.2±4.5 28.3±4.5 28.5±4.5 0.2 (−0.2–0.5)
FFMI kg·m
−2
19.6±3.2 19.5±3.0 19.5±2.8 19.5±2.8 0.1 (−0.4–0.6)
Health-related quality of life CAT 12±8 11±7
+
12±7 10±7
+
−0.7 (−2.1–0.6)
Health-related quality of life CCQ total 1±1 1±1 1±1 1±1 −0.1 (−0.3–0.1)
Anxiety HAD-A 5±4 4±4
+
5±4 5±4 0.2 (−0.5–0.9)
Depression HAD-D 3±3 3±3 3±3 2±3
+
−0.5 (−1.1–0.1)
Exploratory outcomes
Cognitive status (phototest) 37±5 36±5 36±5 36±6 0.5 (−0.4–1.5)
Physical activity experience (C-PPAC total score) 79±12 78±11 79±11 84±11
+
5.2 (1.3–9.2)
+
Physical activity experience of amount (C-PPAC amount) 75±15 74±14 76±12 80±13
+
5.7 (1.1–10.2)
+
Physical activity experience of difficulty (C-PPAC difficulty) 83±13 81±13 83±16 88±14
+
5.0 (0.3–9.6)
+
Data are presented as n, mean±SD or adjusted difference (95% CI). 6MWD: 6-min walking distance; BMI: body mass index; FFMI: fat-free mass
index; CAT: COPD Assessment Test; CCQ: Clinical COPD Questionnaire; HAD: Hospital Anxiety and Depression Scale; C-PPAC: Clinical visit –
PROactive Physical Activity in COPD (higher numbers indicate a better score).
#
: some variables have missing values, as follows. At baseline in
the usual-care group: severe COPD exacerbations (n=1), FFMI (n=18), HAD-A (n=2), HAD-D (n=2), C-PPAC total (n=24), C-PPAC amount (n=23)
and C-PPAC difficulty (n=24); at 12 months in the usual-care group: severe COPD exacerbations (n=5), 6MWD (n=7), BMI (n=2), FFMI (n=2), CAT
(n=1), CCQ total (n=1), HAD-A (n=1), HAD-D (n=1), cognitive status (n=1) and C-PPAC total, amount and difficulty scores (n=63); at baseline in
Urban Training group: severe COPD exacerbations (n=1), FFMI (n=5), HAD-D (n=1) and C-PPAC total, amount and difficulty scores (n=24); at
12 months in Urban Training group: severe COPD exacerbations (n=2), 6MWD (n=1), CCQ total (n=1), HAD-D (n=1) and C-PPAC total, amount
and difficulty scores (n=47);
¶
: multivariable models (linear regression for all outcomes except exacerbations where logistic regression was
used) adjusted by group, forced expiratory volume in 1 s/forced vital capacity ratio, smoking, diabetes, HAD-depression score (online
supplementary material) and the corresponding outcome values at baseline;
+
: p-value of final versus baseline <0.05;
§
: p-value for group
differences <0.05.
https://doi.org/10.1183/13993003.00063-2018 8
COPD | A. ARBILLAGA-ETXARRI ET AL.
usual-care group, without differences in lower-extremity joint pain or other adverse events. This could be
attributed to the fact that the Urban Training walking trails included ramps and stairs that may promote
eccentric work of the leg muscles, which may result in muscle but not joint pain [33]. Second, although a
recent trial has reported an acute increase in respiratory symptoms after walking in urban polluted areas [34],
we did not collect information on these potential adverse events because 1) most of the trails were located in
green or blue areas and 2) residential air pollution exposure was comparable between groups by design.
Finally, the fact that patients included in the ITT but not in the per-protocol analysis set experienced greater
decline in physical activity than those in the per-protocol analysis set could suggest that the intervention was
harmful for them (which could have made them non-adherent). However, this is not supported by the fact
that they experienced the same frequency of adverse events during or after walks as the rest of the Urban
Training group and that a natural decline of physical activity levels has been observed previously in the
absence of interventions [35, 36].
The Urban Training intervention did not improve most of the secondary and exploratory outcomes. The
lack of effect on functional exercise capacity was unexpected, since, based on the physiological response
generated when walking the trails during the validation study [17], we hypothesised that the intervention
could produce effects similar to those of typical exercise training interventions. However, the lack of daily
supervision when walking the trails may have hindered patients from regularly achieve a minimum
training intensity (e.g. walking at a pace that generates dyspnoea or fatigue scores between 4 and 6 in the
Borg scale). Indeed, a previous intervention that increased both physical activity and functional exercise
capacity after 3 months had included close patient supervision via telecoaching [8]. The remaining
secondary outcomes (severe COPD exacerbations, body composition, quality of life, anxiety or depression)
were not primarily targeted by any of the Urban Training components and their improvement was
expected only as a result of the expected increase in physical activity. Based on our results, it is tempting
to speculate that the improvement in physical activity levels would need to be sustained for a period
>12 months in order to result in measurable changes in the other health outcomes. Another explanation is
TABLE 3 Effectiveness results (intention to treat analysis set) of Urban Training intervention at 12 months in chronic obstructive
pulmonary disease (COPD) patients
Usual care
#
Urban Training
#
Adjusted difference
(95% CI) at 12 months
¶
Baseline 12 months Baseline 12 months
Subjects n 148 132
Primary outcome
Steps per day 7783±3847 7825±3850 8069±4554 8002±4635 −24 (−741–693)
Secondary outcomes
Any severe COPD exacerbation in previous 12 months % 14 17
+
817
+
0.3 (−0.4–1.0)
6MWD m 501±83 493±90
+
499±95 488±106
+
−1.5 (−11–8)
BMI kg·m
−2
28.3±4.6 28.3±4.5 28.4±5.0 28.5±5.2 0.0 (−0.3–0.4)
FFMI kg·m
−2
19.6±3.2 19.5±3.0 19.6±3.0 19.6±3.1 0.1 (−0.4–0.5)
Health-related quality of life (CAT) 12±8 11±7 12±7 11±7
+
0.1 (−1.1–1.2)
Health-related quality of life (CCQ total) 1±1 1±1 1±1 1±1
+
−0.1 (−0.3–0.1)
Anxiety (HAD-A) 5±4 4±4
+
5±4 5±4
+
0.2 (−0.4–0.9)
Depression (HAD-D) 3±3 3±3 4±3 3±3
+
−0.5 (−1.0–0.1)
Exploratory outcomes
Cognitive status (phototest) 37±5 36±5 36±5 37±5 0.6 (−0.2–1.5)
Physical activity experience (C-PPAC total) 79±12 77±12 78±12 80±14 2.6 (−0.8–6.0)
Physical activity experience of amount (C-PPAC amount) 75±15 73±15 74±15 74±18 1.5 (−2.5–5.5)
Physical activity experience of difficulty (C-PPAC difficulty) 83±13 81±14 82±15 85±15
+
3.8 (−0.2–7.9)
Data are presented as mean±SD, unless otherwise stated. 6MWD: 6-min walking distance; BMI: body mass index; FFMI: fat-free mass index;
CAT: COPD Assessment Test; CCQ: Clinical COPD Questionnaire; HAD: Hospital Anxiety and Depression Scale; C-PPAC: Clinical visit –
PROactive Physical Activity in COPD (higher numbers indicate a better score).
#
: some variables have missing values, as follows. At baseline in
the usual-care group: severe COPD exacerbations (n=1), FFMI (n=18), HAD-A (n=2), HAD-D (n=2), C-PPAC total (n=25), C-PPAC amount (n=24)
and C-PPAC difficulty (n=25); at 12 months in the usual-care group: severe COPD exacerbations (n=5), 6MWD (n=8), BMI (n=3), FFMI (n=3), CAT
(n=2), CCQ total (n=2), HAD-A (n=2), HAD-D (n=2), cognitive status (n=2) and C-PPAC total, amount and difficulty scores (n=64); at baseline in
Urban Training group: severe COPD exacerbations (n=2), FFMI (n=12), CCQ total (n=2), HAD-D (n=1) and C-PPAC total, C-PPAC amount and
C-PPAC difficulty (n=35); at 12 months in Urban Training group: severe COPD exacerbations (n=5), 6MWD (n=3), BMI (n=2), FFMI (n=2), CAT
(n=2), CCQ total (n=3), HAD-A (n=2), HAD-D (n=4), cognitive status (n=2) and C-PPAC total, amount and difficulty scores (n=70);
¶
: multivariable
models (linear regression for all outcomes except exacerbations where logistic regression was used) adjusted by group and the corresponding
outcome values at baseline;
+
p-value of final versus baseline <0.05.
https://doi.org/10.1183/13993003.00063-2018 9
COPD | A. ARBILLAGA-ETXARRI ET AL.
that our patients already had a relatively good health status as per their values in COPD admissions,
quality of life, anxiety or depression; therefore, they had little room for improvement. Finally, the Urban
Training intervention improved patients’experience of their physical activity (exploratory outcome), in both
the amount and difficulty dimensions, which supports that this concept provides complementary information
to other related constructs such as health-related quality of life or exercise-induced symptoms [37].
The findings of this study are encouraging for COPD research and its management as well as for physical
activity promotion in other populations. First, our findings highlight the consideration of patients’
interpersonal (social and cultural) factors and environment when designing further interventions. From
the clinical viewpoint, this approach may appear more feasible than others based strongly on technology
solutions, particularly in countries with limited healthcare budgets. Second, our study supports the
involvement of behaviour specialists in the design and administration of physical activity interventions or
an equivalent acquisition of knowledge on behavioural techniques by health professionals who generally
Adjusted difference in steps
(95% CI) at 12 months
957 (184–1730), p=0.015
+816
+64
5000
6000
7000
8000
9000
10 000
a) b)
Baseline BaselineMonth 12 Month 12
Steps per day
5000
6000
7000
8000
9000
10 000
Steps per day
Urban Training Usual care
Adjusted difference in steps
(95% CI) at 12 months
-24 (-741–693), p=0.947
+42
–67
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.
–2000
Severe to very severe COPD
Mild to moderate COPD
6MWD ≥500 m
Charlson index <2
Charlson index ≥2
≥7100 steps·day–1
<7000 steps·day–1
6MWD <500 m
–1000
0
1000
2000
3000
Adjusted difference steps (95% CI)
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].
https://doi.org/10.1183/13993003.00063-2018 10
COPD | A. ARBILLAGA-ETXARRI ET AL.
exhibit a lack of training in behavioural change techniques [38, 39]. Finally, at the city level, interventions
such as the Urban Training may contribute towards amortising the investment in public space (otherwise
underused during certain times of the day) thus improving its sustainability. In fact, a close collaboration
between health professionals and local governments has been promoted for example in the World Health
Organization Healthy Cities project and is likely to result in social, economic and health benefits for all [40].
A limitation of the current study is that we defined adherence, and consequently the per-protocol analysis
set, according to patient report. It is of note that we defined “non-adherence”from patient report and
“adherence”otherwise. Thus, the ITT analysis set included, in the first place, patients who at baseline
spontaneously reported unwillingness to undergo the intervention they had been assigned to. These patients
are most often excluded from clinical trials, but we decided to keep them (and analyse their data) in order to
provide effectiveness estimates. Second, the ITT analysis set included in addition patients who reported at the
12-month visit that they had not been adherent to the intervention to which they had been assigned, which
in most cases, was due to a family situation (e.g. partner undergoing surgery). Again, some of these patients
would be excluded in traditional clinical trials. Finally, the per-protocol analysis set included patients who
did not make any spontaneous report in relation to their willingness or adherence, and probably comprised
both adherent and non-adherent patients, thus underestimating the efficacy of Urban Training.
A second limitation is the apparent discrepancy between efficacy and effectiveness results. Of note, both
approaches were prespecified in our analysis plan given previous reports in the literature about poor
adherence to behavioural interventions [9, 41] and the well-known argument against ITT analysis (that it
underestimates intervention effects in situations of non-adherence) [42]. The absence of effectiveness of
Urban Training suggests the need for research to understand and eventually to identify ways to act upon
the determinants of willingness and adherence to behavioural interventions in COPD. In our study,
airflow limitation, smoking habits, diabetes and depression symptoms, but not physical activity levels were
related to unwillingness or non-adherence, although collected information was not complete and there are
no previous data on these issues to compare with. In addition, it has been disputed that the adherence to a
given intervention may change dramatically after patients learn of trial findings, making the ITT effect
estimation different from the effectiveness of the intervention in the community [43]. From a clinical
viewpoint, patients who are willing to take an intervention such as Urban Training may be more interested
in the per-protocol than the ITT effect.
Other shortcomings include the lack of intermediate assessments during the follow-up period, which could
have given feedback to patients and would have allowed researchers to distinguish between short- and
long-term effects. In addition, the fact that ≈30% of patients were lost to follow-up, a comparable figure to
previous studies [6, 9, 10], could have biased our results. Finally, our patients exhibited higher physical
activity levels than those observed in previous studies [44–47], which could be considered a limitation of
our research. However, a comparison of the clinical characteristics and physical activity levels of the
patients included in the present and previous studies shows differences in physical activity both between
countries (for the same severity of COPD) and within countries (for different severity stages and/or
recruitment settings). We consider that, given that the Urban Training intervention was designed in a
region characterised by relatively high social support, the cultural habit of walking, pedestrian accessibility
TABLE 4 Adverse events during or after walks in the safety analysis set
Usual care Urban Training p-value
Subjects n 142 128
Any adverse event 103 (73) 99 (77) 0.363
Lower-extremity joint pain 38 (27) 41 (32) 0.342
Lower-extremity muscle pain 36 (25) 48 (38) 0.031
General malaise or fatigue 61 (43) 57 (45) 0.795
Dizziness 12 (8) 9 (7) 0.821
Fainting 1 (1) 0 (0)
Dyspnoea 48 (34) 46 (36) 0.713
Chest discomfort 9 (6) 17 (13) 0.064
Palpitations 22 (16) 23 (18) 0.586
Fall, twist or accident 10 (7) 13 (10) 0.360
Cold, flu or pneumonia 24 (17) 21 (16) 0.913
Heatstroke or dehydration 1 (1) 2 (2) 0.605
Data are presented as n (%), unless otherwise stated.
https://doi.org/10.1183/13993003.00063-2018 11
COPD | A. ARBILLAGA-ETXARRI ET AL.
to most outdoor public spaces, and a mild climate, it would be feasible in most Euro-Mediterranean cities.
However, other geographic areas would need to conduct a proper adaptation to their social, cultural and
environmental characteristics.
Strengths of the study are the novelty of customising the behavioural intervention to patients’interpersonal
characteristics and environment, the large sample size and the measure of physical activity using an
accelerometer. In addition, patients were recruited from primary care and hospitals of several
municipalities, with barely any exclusion criteria, and diversity in relevant sociodemographic, lifestyle and
clinical parameters, which make our results generalisable to a wide COPD population. The lack of
differences in efficacy when patients were stratified according to their baseline features further supports the
generalisability of our findings. With regard to the intervention, its simplicity and reduced burden make it
possible to adapt it to other populations, including those with other chronic diseases and/or settings.
In conclusion, the Urban Training intervention, combining behavioural strategies with unsupervised
outdoor walking, was efficacious in increasing physical activity after 12 months in COPD patients.
However, it was ineffective in the full population including unwilling and self-reported non-adherent
patients. The Urban Training intervention had no effect on severe COPD exacerbations, functional
exercise capacity, body composition, health-related quality of life, anxiety or depression.
Acknowledgements: The authors thank all the technical staff of the Respiratory Diagnostic Centre from Hospital Clínic
de Barcelona (Barcelona, Spain); Laura Gutierrez, Concepción Ballano, Anna Rodó-Pin, Bea Valeiro, Mireia Admetlló
and Sergi Pascual from the Pneumology Department of Hospital del Mar (Barcelona); Alicia Francoso Vicente and Júlia
Moraleda Hidalgo from the Pneumology Department of Hospital Germans Trias i Pujol (Badalona, Spain); and Marta
Delicado and the Administration Department from the Viladecans 2 Primary care centre (Viladecans, Spain) for their
contribution to the study.
Author contributions: A. Arbillaga-Etxarri and J. Garcia-Aymerich prepared the first draft of the paper;
A. Arbillaga-Etxarri, M. Benet and J. Garcia-Aymerich had full access to the data and carried out statistical
analysis. A. Arbillaga-Etxarri, E. Gimeno-Santos, A. Barberan-Garcia, E. Balcells, E. Borrell, N. Celorrio, A. Delgado,
C. Jané, A. Marin, C. Martín-Cantera, M. Monteagudo, N. Montellà, P. Ortega, D.A. Rodríguez, P. Simonet,
P. Torán-Monserrat, J. Torrent-Pallicer and J. Garcia-Aymerich contributed to data collection and coordination. All
authors 1) provided substantial contributions to the conception or design of the work, or the acquisition, analysis or
interpretation of data for the work; 2) revised the manuscript for important intellectual content; 3) approved the final
version; and 4) agreed to be accountable for all aspects of the work. J. Garcia-Aymerich had full access to all of the data
in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Conflict of interest: A. Arbillaga-Etxarri has nothing to disclose. E. Gimeno-Santos has nothing to disclose.
A. Barberan-Garcia has nothing to disclose. E. Balcells has nothing to disclose. M. Benet has nothing to disclose.
E. Borrell has nothing to disclose. N. Celorrio has nothing to disclose. A. Delgado has nothing to disclose. C. Jané has
nothing to disclose. A. Marin has nothing to disclose. C. Martín-Cantera has nothing to disclose. M. Monteagudo has
nothing to disclose. N. Montellà has nothing to disclose. L. Muñoz has nothing to disclose. P. Ortega has nothing to
disclose. D.A. Rodríguez has nothing to disclose. 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. P. Simonet reports personal
fees for speaking from Menarini, Gebro, Teva, Boehringer, Rovi, AstraZeneca and GSK, outside the submitted work.
P. Torán-Monserrat has nothing to disclose. J. Torrent-Pallicer has nothing to disclose. P. Vall-Casas has nothing to
disclose. J. Vilaró has nothing to disclose. 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.
Support statement: The study was funded by grants from Fondo de Investigación Sanitaria, Instituto de Salud Carlos III
(ISCIII, PI11/01283 and PI14/0419), integrated into Plan Estatal I+D+I 2013–2016 and co-funded by
ISCIII-Subdirección General de Evaluación y Fomento de la Investigación and Fondo Europeo de Desarrollo Regional
(FEDER); Sociedad Española de Neumología y Cirugía Torácica (SEPAR, 147/2011 and 201/2011), Societat Catalana de
Pneumologia (Ajuts al millor projecte en fisioteràpia respiratòria 2013). ISGlobal is a member of the CERCA
Programme, Generalitat de Catalunya. Anael Barberan-Garcia had personal funding from AGAUR 2014-SGR-661,
Catalan Government. The funders had no role in study design, data collection and analysis, decision to publish, or
preparation of the manuscript. Funding information for this article has been deposited with the Crossref Funder
Registry.
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