Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
chronic obstructive pulmonary disease (COPD), urban training, physical activity, active aging
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.
Interventions
BEHAVIORALUrban training
Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.
Sponsors
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
Judith Garcia-Aymerich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 130 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in cognitive status | Baseline and 12months | Changes between baseline and 12 months follow-up in cognitive status measured with the Phototest |
| Changes in the Clinical PPAC | 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 |
Countries
Spain
Outcome results
None listed