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Urban Training for COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Urban training
Sponsored by
Judith Garcia-Aymerich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring chronic obstructive pulmonary disease (COPD), urban training, physical activity, active aging

Eligibility Criteria

45 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Germans Trias i Pujol
  • CAP Maresme
  • CAP Maria Bernades
  • Hospital del Mar
  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Urban training Intervention

Usual care

Arm Description

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

Patients will continue their usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

COPD admissions to emergency-room or hospital
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
Change in body weight and composition
Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance
Change in quality of life
Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ
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

Full Information

First Posted
July 3, 2013
Last Updated
April 26, 2018
Sponsor
Judith Garcia-Aymerich
Collaborators
Instituto de Salud Carlos III, Sociedad Española de Neumología (SEPAR), Barcelona, University Ramon Llull, Hospital Clinic of Barcelona, Hospital del Mar, Germans Trias i Pujol Hospital, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Hospital de Mataró, Mataró, Hospital de Viladecans, Viladecans, Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT01897298
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Judith Garcia-Aymerich
Collaborators
Instituto de Salud Carlos III, Sociedad Española de Neumología (SEPAR), Barcelona, University Ramon Llull, Hospital Clinic of Barcelona, Hospital del Mar, Germans Trias i Pujol Hospital, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Hospital de Mataró, Mataró, Hospital de Viladecans, Viladecans, Universitat Internacional de Catalunya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
chronic obstructive pulmonary disease (COPD), urban training, physical activity, active aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urban training Intervention
Arm Type
Experimental
Arm Description
Patients will be advised to walk in the defined urban trails.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients will continue their usual care
Intervention Type
Behavioral
Intervention Name(s)
Urban training
Intervention Description
Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.
Primary Outcome Measure Information:
Title
Change in physical activity
Description
Change in physical activity between baseline and 12 months follow-up, as defined by average steps per day measured with an activity monitor
Time Frame
Baseline and 12 months follow-up
Secondary Outcome Measure Information:
Title
COPD admissions to emergency-room or hospital
Time Frame
12 months follow-up
Title
Change in exercise capacity, as measured with 6-min walking distance
Description
Change in exercise capacity between baseline and 12 months, as measured with 6-min walking distance
Time Frame
Baseline and 12 months
Title
Change in body weight and composition
Description
Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance
Time Frame
Baseline and 12 month
Title
Change in quality of life
Description
Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ
Time Frame
Baseline and 12-m
Title
Change in anxiety and depression symptoms
Description
Change in anxiety and depression symptoms between baseline and 12 months follw-up, as measured with the HAD scale
Time Frame
Baseline and 12 months
Other Pre-specified Outcome Measures:
Title
Changes in cognitive status
Description
Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest
Time Frame
Baseline and 12months
Title
Changes in the Clinical PPAC
Description
Changes between baseline and 12 months follow-up in phsyical activity measured with the Clinical visit "PROactive Physical Activity in COPD" instrument
Time Frame
Baseline and 12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Garcia-Aymerich, MD PhD
Organizational Affiliation
Centre for Research in Environmental Epidemiology (CREAL)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
CAP Maresme
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08303
Country
Spain
Facility Name
CAP Maria Bernades
City
Viladecans
State/Province
Barcelona
ZIP/Postal Code
08840
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33662597
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.
Results Reference
derived
PubMed Identifier
31107900
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.
Results Reference
derived
PubMed Identifier
30166322
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.
Results Reference
derived
PubMed Identifier
28250201
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.
Results Reference
derived

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Urban Training for COPD Patients

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