NCT01897298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

July 3, 2013

Last Update Submit

April 26, 2018

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease (COPD)urban trainingphysical activityactive aging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • COPD admissions to emergency-room or hospital

    12 months follow-up

  • Change in exercise capacity, as measured with 6-min walking distance

    Baseline and 12 months

  • Change in body weight and composition

    Baseline and 12 month

  • Change in quality of life

    Baseline and 12-m

  • Change in anxiety and depression symptoms

    Baseline and 12 months

Other Outcomes (2)

  • Changes in cognitive status

    Baseline and 12months

  • Changes in the Clinical PPAC

    Baseline and 12months

Study Arms (2)

Urban training Intervention

EXPERIMENTAL

Patients will be advised to walk in the defined urban trails.

Behavioral: Urban training

Usual care

NO INTERVENTION

Patients will continue their usual care

Interventions

Urban trainingBEHAVIORAL

Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.

Urban training Intervention

Eligibility Criteria

Age45 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

CAP Maresme

Mataró, Barcelona, 08303, Spain

Location

CAP Maria Bernades

Viladecans, Barcelona, 08840, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (4)

  • 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.

    PMID: 33662597DERIVED

  • 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.

    PMID: 31107900DERIVED

  • 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.

    PMID: 30166322DERIVED

  • 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.

    PMID: 28250201DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Judith Garcia-Aymerich, MD PhD

    Centre for Research in Environmental Epidemiology (CREAL)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Research Professor

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 11, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

April 27, 2018

Record last verified: 2018-04

Locations

ES(5)