Urban Training for COPD Patients

Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Urban training

• Study Type: Interventional
• Enrollment (Actual): 412
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Hospital Clínic
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
    • Mataró, Barcelona, Spain, 08303
      • CAP Maresme
    • Viladecans, Barcelona, Spain, 08840
      • CAP Maria Bernades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urban training Intervention; Patients will be advised to walk in the defined urban trails.	Behavioral: Urban training; Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.
No Intervention: Usual care; Patients will continue their usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity	Change in physical activity between baseline and 12 months follow-up, as defined by average steps per day measured with an activity monitor	Baseline and 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD admissions to emergency-room or hospital		12 months follow-up
Change in exercise capacity, as measured with 6-min walking distance	Change in exercise capacity between baseline and 12 months, as measured with 6-min walking distance	Baseline and 12 months
Change in body weight and composition	Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance	Baseline and 12 month
Change in quality of life	Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ	Baseline and 12-m
Change in anxiety and depression symptoms	Change in anxiety and depression symptoms between baseline and 12 months follw-up, as measured with the HAD scale	Baseline and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cognitive status	Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest	Baseline and 12months
Changes in the Clinical PPAC	Changes between baseline and 12 months follow-up in phsyical activity measured with the Clinical visit "PROactive Physical Activity in COPD" instrument	Baseline and 12months

Collaborators and Investigators

• Sponsor: Judith Garcia-Aymerich
• Collaborators: Hospital Clinic of Barcelona; Germans Trias i Pujol Hospital; Hospital del Mar; Instituto de Salud Carlos III; Universitat Internacional de Catalunya; University Ramon Llull; Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina; Sociedad Española de Neumología (SEPAR), Barcelona; Hospital de Mataró, Mataró; Hospital de Viladecans, Viladecans
• Investigators: Principal Investigator: Judith Garcia-Aymerich, MD PhD, Centre for Research in Environmental Epidemiology (CREAL)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; chronic obstructive pulmonary disease (COPD); active aging; urban training
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PI11/01283; 147/2011 (Other Grant/Funding Number: SEPAR)