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Urban Training for COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01897298
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : April 27, 2018
Sponsor:
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
Information provided by (Responsible Party):
Judith Garcia-Aymerich, Barcelona Institute for Global Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Urban training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial
Study Start Date : July 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in physical activity [ Time Frame: Baseline and 12 months follow-up ]
    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 :
  1. COPD admissions to emergency-room or hospital [ Time Frame: 12 months follow-up ]
  2. Change in exercise capacity, as measured with 6-min walking distance [ Time Frame: Baseline and 12 months ]
    Change in exercise capacity between baseline and 12 months, as measured with 6-min walking distance

  3. Change in body weight and composition [ Time Frame: Baseline and 12 month ]
    Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance

  4. Change in quality of life [ Time Frame: Baseline and 12-m ]
    Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ

  5. Change in anxiety and depression symptoms [ Time Frame: Baseline and 12 months ]
    Change in anxiety and depression symptoms between baseline and 12 months follw-up, as measured with the HAD scale


Other Outcome Measures:
  1. Changes in cognitive status [ Time Frame: Baseline and 12months ]
    Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest

  2. Changes in the Clinical PPAC [ Time Frame: Baseline and 12months ]
    Changes between baseline and 12 months follow-up in phsyical activity measured with the Clinical visit "PROactive Physical Activity in COPD" instrument


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897298


Locations
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Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
CAP Maresme
Mataró, Barcelona, Spain, 08303
CAP Maria Bernades
Viladecans, Barcelona, Spain, 08840
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Judith Garcia-Aymerich
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
Investigators
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Principal Investigator: Judith Garcia-Aymerich, MD PhD Centre for Research in Environmental Epidemiology (CREAL)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Judith Garcia-Aymerich, Associate Research Professor, Barcelona Institute for Global Health
ClinicalTrials.gov Identifier: NCT01897298    
Other Study ID Numbers: PI11/01283
147/2011 ( Other Grant/Funding Number: SEPAR )
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Keywords provided by Judith Garcia-Aymerich, Barcelona Institute for Global Health:
chronic obstructive pulmonary disease (COPD)
urban training
physical activity
active aging
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes