Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial
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.


Options:
A: Inclusion Criteria:

* Currently in a stable phase of COPD, defined as having had no disease exacerbation within the 4 weeks prior to study entry
* Ambulatory
* Forced expiratory volume in one second (FEV1) less than or equal to 60% of predicted value at screening
* Ratio of FEV1 and forced vital capacity (FEV1/FVC) less than or equal to 65% of predicted value at screening
* Currently receiving long-term oxygen therapy (LTOT)
* Partial pressure of oxygen in arterial blood (PaO2) less than 60 torr

Exclusion Criteria:

* Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, left-sided heart failure, peripheral vascular disease, exertional angina, complex arrhythmias, severe dependent edema, ischemic changes on stress electrocardiogram that would be contraindications for unrestricted ambulation or the 6-minute walk test)
* Orthopedic impairments that would limit ambulation
* Participation in the active phase of pulmonary rehabilitation within the 3 months prior to study entry
* Neurologic impairments (e.g., Parkinson's disease or a stroke) or mental states (e.g., senile dementia) that would limit independent ambulation
* Neoplastic disease that is anticipated to influence survival
* Currently receiving lightweight ambulatory oxygen therapy
* Inability to maintain an oxygen saturation of 92% at rest with 4 liter/minute of continuous oxygen flow and during exercise with an oxygen conserver setting of 6 utilizing a nasal cannula
* Currently a smoker
* Sleep apnea if it is characterized primarily as central sleep apnea syndrome (whether being treated or not) OR if it is known or suspected obstructive sleep apnea that has existed for at least 2 months and has not received stable treatment (stable treatment modes include positive airway pressure therapies or dental orthotic/mandibular positioning devices); individuals with diagnosed obstructive sleep apnea must have a body mass index less than or equal to 30 kg/m2 to be eligible for this study
B: Inclusion criteria:

* All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
* All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator Forced expiratory volume in one second (FEV1) \< 80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) \< 70% at Visit 1.

* Male or female patients, aged \>= 40 years.
* Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
* Patients with score on the modified Medical Research Council (mMRC) \>= 1.
* Patients who walk \< 400 meters of 6MWT and have a score on the modified Borg \>= 4 at the end of 6 minute walk test (6MWT) at Visit 2.
* Patients must be able to perform technically acceptable pulmonary function tests (spirometry), to use the physical activity monitor and must be able to complete 6MWT during the study period as required in the protocol.
* Patients must be able to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler.

Exclusion criteria:

* Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study.
* Patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine \> x2 upper limit of normal (ULN) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator).
* Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
* Further exclusion criteria apply
C: 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.
D: Inclusion Criteria:

* Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
* Post-salbutamol Forced Expiratory Volume in one second(FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) \< 70%.
* Current or ex-smokers of ≥ 10 pack-years
* Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria:

* History or current diagnosis of asthma
* Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
* Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
* Patients with an oxygen saturation \< 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
* Contra-indications of cardiopulmonary exercise testing.
* Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.

Answer: C