Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire \[CRQ\] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.


Options:
A: Inclusion Criteria:

1. bronchodilator naïve patients
2. Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and \<80 % of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70)
3. patients who are residents in Xingning city (Guangdong Province, China) will be recruited.

Exclusion Criteria:

1. Patients currently or previous on any type of Tai Chi exercise or pulmonary rehabilitation
2. Patients with a history of malignancy of any organ system treated or untreated, within the past 5 years.
3. Patients with clinically significant renal, cardiovascular, neurological, metabolism, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities.
4. Patients with concomitant pulmonary disease (e.g. asthma, lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, tuberculosis)
5. Patients with obesity (BMI\> 40 kg/m2).
6. Patients requiring long term oxygen therapy (\> 12 h a day) on a daily basis for chronic hypoxemia or recovering from acute exacerbation less than 6 weeks.
7. Patients with Asthma.
B: Inclusion Criteria:

* A physician diagnosis of COPD
* Age 45 years and older
* Affirmative response to "Are you short of breath when hurrying on the level or walking up a slight hill?"
* Post-bronchodilator FEV1/FVC \<0.7 and FEV1 \<70%

Exclusion Criteria:

* Inability to speak/read English
* Lives in a chronic care facility (i.e., nursing home, assisted living)
* Plans to move from the area within the next 18 months
* Life expectancy less than 12 months
* Participation in pulmonary rehabilitation or other clinical research in the past 12 months
* Inability to walk without assistance of a wheelchair or walker
* Inability to walk at least 110m on a 6-minute walk
* Uncontrolled angina, hypertension, psychiatric illness, or dementia
* Inability to obtain supplemental oxygen if indicated
C: Inclusion Criteria:

Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..

Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and \<80% of the predicted normal, and a post-bronchodilator FEV1/FVC \<0.70

Exclusion Criteria:

Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.

Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate \< 100/min.

Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.

Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.

Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.

Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.

Patients who have had a respiratory tract infection within 4 weeks prior to screening.

Patients with any history of asthma. Patients with concomitant pulmonary disease Patients with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion criteria may apply
D: Inclusion Criteria:

* Spirometry-proven COPD
* Referred for 6-month outpatient pulmonary rehabilitation program

Exclusion Criteria:

* Orthopedic problems impairing daily activities
* Progressive neurological or neuromuscular disorders
* Psychiatric or cognitive disorders
* Patients on the waiting list for lung transplantation

Answer: B