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Urban Training for COPD Patients
This study has been completed.
Sponsor:
Judith Garcia-Aymerich
Collaborators:
Instituto de Salud Carlos III, Fondo de Investigación Sanitaria, Madrid
Sociedad Española de Neumología (SEPAR), Barcelona
University Ramon Llull
Hospital Clinic of Barcelona
Hospital del Mar
Germans Trias i Pujol Hospital
IDIAP Jordi Gol, Barcelona
Hospital de Mataró, Mataró
Hospital de Viladecans, Viladecans
Universitat Internacional de Catalunya
Information provided by (Responsible Party):
Judith Garcia-Aymerich, Centre for Research in Environmental Epidemiology, Spain
ClinicalTrials.gov Identifier:
NCT01897298
First received: July 3, 2013
Last updated: April 29, 2016
Last verified: April 2016
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Purpose
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 | Intervention |
|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Behavioral: Urban training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Judith Garcia-Aymerich, Centre for Research in Environmental Epidemiology, Spain:
Primary Outcome Measures:
- 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:
- COPD admissions to emergency-room or hospital [ Time Frame: 12 months follow-up ]
- 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
- 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
- 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
- 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:
- Changes in cognitive status [ Time Frame: Baseline and 12months ]Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest
- 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
| Enrollment: | 412 |
| Study Start Date: | July 2013 |
| Study Completion Date: | March 2016 |
| Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 45 Years to 130 Years (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897298
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897298
Locations
| 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, Fondo de Investigación Sanitaria, Madrid
Sociedad Española de Neumología (SEPAR), Barcelona
University Ramon Llull
Hospital Clinic of Barcelona
Hospital del Mar
Germans Trias i Pujol Hospital
IDIAP Jordi Gol, Barcelona
Hospital de Mataró, Mataró
Hospital de Viladecans, Viladecans
Universitat Internacional de Catalunya
Investigators
| Principal Investigator: | Judith Garcia-Aymerich, MD PhD | Centre for Research in Environmental Epidemiology (CREAL) |
More Information
| Responsible Party: | Judith Garcia-Aymerich, Associate Research Professor, Centre for Research in Environmental Epidemiology, Spain |
| ClinicalTrials.gov Identifier: | NCT01897298 History of Changes |
| Other Study ID Numbers: |
PI11/01283 147/2011 ( Other Grant/Funding Number: SEPAR ) |
| Study First Received: | July 3, 2013 |
| Last Updated: | April 29, 2016 |
Keywords provided by Judith Garcia-Aymerich, Centre for Research in Environmental Epidemiology, Spain:
|
chronic obstructive pulmonary disease (COPD) urban training physical activity active aging |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on July 17, 2017