Urban Training for COPD Patients

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Behavioral: Urban training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 130 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urban training Intervention<br>Patients will be advised to walk in the defined urban trails. | Behavioral: Urban training<br>* Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.<br>|
| No Intervention: Usual care<br>Patients will continue their usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD admissions to emergency-room or hospital |  | 12 months follow-up | 
| 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 | Baseline and 12 months | 
| Change in body weight and composition | Change in body weight and composition between baseline and 12m follow-up, as measured with bioimpedance | Baseline and 12 month | 
| Change in quality of life | Change in quality of life between baseline and 12-m follow-up, as measured with CAT and CCQ | Baseline and 12-m | 
| 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 | Baseline and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urban training, chronic obstructive pulmonary disease (COPD), physical activity, active aging