Clinical trial NCT01897298: Urban Training for COPD Patients
Official title: Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic obstructive pulmonary disease (COPD)
urban training
physical activity
active aging
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Sociedad Española de Neumología (SEPAR), Barcelona
name: University Ramon Llull
name: Hospital Clinic of Barcelona
name: Hospital del Mar
name: Germans Trias i Pujol Hospital
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Hospital de Mataró, Mataró
name: Hospital de Viladecans, Viladecans
name: Universitat Internacional de Catalunya
First posted: 2013-07-11
Enrollment: 412
Sex: ALL
Minimum age (years): 45
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project plans on a training intervention by using public spaces and urban walkable trails, adapted to each patient needs and capabilities. Primary objective is to assess 12 months effectiveness of the intervention with respect to: (primary outcome): physical activity level, and (secondary outcomes): COPD admissions, exercise capacity, body composition, quality of life, and mental health.


Eligibility criteria: Inclusion Criteria:

* age \> 45 years
* COPD diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ≤ 0.70
* clinical stability, defined as at least 4 weeks without antibiotics or oral corticosteroids.

Exclusion Criteria:

* living \>6 months/year outside of the included municipalities,
* living to a distance higher than 500 meters to any of the urban trails used for the study,
* mental disability according to the Mini Mental State Examination in its validated Spanish version
* comorbidity that could interfere with study tests (e.g., lower limb amputation)
* severe psychiatric disease or severe comorbidity limiting survival at one year, according to medical history.

Primary outcomes:
measure: Change in physical activity
timeFrame: Baseline and 12 months follow-up
Secondary outcomes:
measure: COPD admissions to emergency-room or hospital
timeFrame: 12 months follow-up
measure: Change in exercise capacity, as measured with 6-min walking distance
timeFrame: Baseline and 12 months
measure: Change in body weight and composition
timeFrame: Baseline and 12 month
measure: Change in quality of life
timeFrame: Baseline and 12-m
measure: Change in anxiety and depression symptoms
timeFrame: Baseline and 12 months
Other outcomes:
measure: Changes in cognitive status
timeFrame: Baseline and 12months
measure: Changes in the Clinical PPAC
timeFrame: Baseline and 12months
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Mataró
country: Spain
facility: CAP Maresme
state: Barcelona
city: Viladecans
country: Spain
facility: CAP Maria Bernades
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Centre for Research in Environmental Epidemiology (CREAL)
name: Judith Garcia-Aymerich, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delgado-Ortiz L, Arbillaga-Etxarri A, Rodriguez-Chiaradia DA, Gimeno-Santos E, Barberan-Garcia A, Balcells E, Rodriguez-Roisin R, Garcia-Aymerich J. Physical activity and cardiac autonomic dysfunction in patients with chronic obstructive pulmonary disease: A cross-sectional analysis. Ann Phys Rehabil Med. 2022 May;65(3):101501. doi: 10.1016/j.rehab.2021.101501. Epub 2021 Nov 22.
citation: Koreny M, Demeyer H, Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Benet M, Balcells E, Borrell E, Marin A, Rodriguez Chiaradia DA, Vall-Casas P, Vilaro J, Rodriguez-Roisin R, Garcia-Aymerich J. Determinants of study completion and response to a 12-month behavioral physical activity intervention in chronic obstructive pulmonary disease: A cohort study. PLoS One. 2019 May 20;14(5):e0217157. doi: 10.1371/journal.pone.0217157. eCollection 2019.
citation: Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Balcells E, Benet M, Borrell E, Celorrio N, Delgado A, Jane C, Marin A, Martin-Cantera C, Monteagudo M, Montella N, Munoz L, Ortega P, Rodriguez DA, Rodriguez-Roisin R, Simonet P, Toran-Monserrat P, Torrent-Pallicer J, Vall-Casas P, Vilaro J, Garcia-Aymerich J. 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 Oct 18;52(4):1800063. doi: 10.1183/13993003.00063-2018. Print 2018 Oct.
citation: Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Benet M, Borrell E, Dadvand P, Foraster M, Marin A, Monteagudo M, Rodriguez-Roisin R, Vall-Casas P, Vilaro J, Garcia-Aymerich J; Urban Training Study Group. Socio-environmental correlates of physical activity in patients with chronic obstructive pulmonary disease (COPD). Thorax. 2017 Sep;72(9):796-802. doi: 10.1136/thoraxjnl-2016-209209. Epub 2017 Mar 1.