Urban Training for COPD Patients

NCT ID: NCT01897298

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Urban training Intervention

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

Group Type EXPERIMENTAL

Urban training

Intervention Type BEHAVIORAL

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

Usual care

Patients will continue their usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Urban training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Sociedad Española de Neumología (SEPAR), Barcelona

UNKNOWN

Sponsor Role collaborator

University Ramon Llull

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role collaborator

Hospital de Mataró, Mataró

UNKNOWN

Sponsor Role collaborator

Hospital de Viladecans, Viladecans

UNKNOWN

Sponsor Role collaborator

Universitat Internacional de Catalunya

OTHER

Sponsor Role collaborator

Judith Garcia-Aymerich

OTHER

Sponsor Role lead

Responsible Party

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Judith Garcia-Aymerich

Associate Research Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Judith Garcia-Aymerich, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Research in Environmental Epidemiology (CREAL)

Locations

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Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

CAP Maresme

Mataró, Barcelona, Spain

Site Status

CAP Maria Bernades

Viladecans, Barcelona, Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33662597 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31107900 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30166322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28250201 (View on PubMed)

Other Identifiers

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147/2011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI11/01283

Identifier Type: -

Identifier Source: org_study_id

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