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:

* Male or female, aged more than 35 years
* Physician labelled diagnosis of COPD, emphysema or chronic bronchitis
* Ex or current smoker of more than 20 pack years
* FEV1 less than 80% of predicted
* Patients may be taking long or short acting bronchodilators and/or inhaled or oral corticosteroids and/or theophyllines.
* Patients having attended at least 60% of the exercise sessions in the initial PR(22)\* \* This is an inclusion criterion for randomisation to receive maintenance PR or standard medical care but not entry into the study

Exclusion Criteria:

* Significant cardiac or pulmonary disease other than COPD such that COPD is the minor contribution to the patients' symptoms.
* Myocardial infarction within the previous 6 months or unstable angina
* Respiratory infection defined as cough, antibiotic use or purulent sputum within 4 weeks prior to randomisation.
* Severe or uncontrolled co-morbid disease, which is likely to affect the outcome of the study.
* Abnormalities in cognitive functioning that would limit the patient's ability to undertake the procedures required in the study.
* Unable to give written informed consent.
B: Inclusion Criteria:

* Diagnosis of COPD
* At least one COPD-related hospitalization or COPD-related emergency department presentation in the previous 12 months to enrollment
* Capable to provide signed written informed consent

Exclusion Criteria:

* Attendance to a rehabilitation program in the previous 6 months of enrollment
* Participation in another study that may have an impact on the outcome of this study
* Deemed by the health care team to be physically uncapable to perform the study procedures
* Presence of comorbidities wich might prevent the patient from safely undertake an exercise program at home
* Home environment not suitable for installation and use of rehabilitation and monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)
C: 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
D: Inclusion Criteria:

* Moderate to severe COPD according to the recent GOLD guidelines
* Reduced exercise capacity during an incremental exercise test of less than 70% of predicted normal values

Exclusion Criteria:

* Lack of motivation to participate in the treatment program
* Other pathologic conditions unabling participation in the training program (e.g. coronary, orthopaedic, neurological or severe endocrine disorders)
* participation in other pulmonary rehabilitation projects

Answer: C