Urban Training for COPD Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Behavioral: Urban training

• Registration Number: NCT01897298
• Lead Sponsor: Judith Garcia-Aymerich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-11
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urban training Intervention	Urban training	Patients will be advised to walk in the defined urban trails.

Primary Outcome Measures

Name	Time	Method
Change in physical activity	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

Name	Time	Method
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 exercise capacity between baseline and 12 months, as measured with 6-min walking distance
Change in body weight and composition	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	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	Baseline and 12 months	Change in anxiety and depression symptoms between baseline and 12 months follw-up, as measured with the HAD scale

Trial Locations

Locations (5)

CAP Maria Bernades; 🇪🇸 Viladecans, Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

CAP Maresme; 🇪🇸 Mataró, Barcelona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain