Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of Maintenance Schedules Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: Chronic obstructive pulmonary disease (COPD), a preventable and treatable condition, is a major healthcare problem with huge human and economic costs. It affects 3 million people, results in 1.4 million consultations, causes 30,000 deaths, and costs £800M per year in the UK. Considerable research expenditure is devoted to finding new and expensive interventions. However pulmonary rehabilitation (PR) is an available therapeutic option with good evidence of benefit for patients in terms of quality of life and daily functioning.

The primary objective of the study is to evaluate the effectiveness and cost effectiveness of the addition of a maintenance programme following pulmonary rehabilitation in patients with COPD when compared to standard care.

The secondary objective is to identify baseline characteristics that will predict improvement in pulmonary rehabilitation programmes and adherence to maintenance strategies. By measuring a series of demographic, clinical, physiological, psychological and biochemical parameters the researchers hope to be able to predict those patients who are likely to receive the greatest benefit from pulmonary rehabilitation.

An additional objective will be to prepare a detailed maintenance programme manual. This will be available to other centres providing pulmonary rehabilitation at the conclusion of the study


Options:
A: Inclusion Criteria:

* COPD (FEV1\< 50%, Tiffeneau \< 70%)
* Dyspnoea on exertion and a reduced exercise capacity
* Age 75 years or less
* PaCO2 \> 6.0 kPa at rest without oxygen

Exclusion Criteria:

* Cardial/neuromuscular diseases limiting a successful rehabilitation
* Obstructive sleep apnoea syndrome: apnea/hypopnea index (AHI) \> 10
* Previous exposure to chronic NIPPV
* Participation in a pulmonary rehabilitation program less than 18 months ago
B: Inclusion Criteria:

* 18 years of age or older.
* Physician diagnosed COPD confirmed by spirometry with the most recent result available defined as a prior post-bronchodilator FEV1/FVC \< 0.7 in accordance with the GOLD 2014 criteria.
* Respiratory physician confirmed optimisation of treatment of COPD.
* On stable medications relating to the optimal treatment of COPD or its symptomatic management over the prior week except routine "as needed" medications.
* Breathlessness of a level three (3) or four (4) on the modified Medical Research Council (mMRC) breathlessness scale.
* worst breathlessness intensity in the previous 24 hours was at least 3/10 on a 0-10 numerical rating scale (NRS).
* English speaking with sufficient reading and writing ability to complete the study questionnaires
* Assessed as competent (using St Louise University Mental Status Examination (SLUMS) score of 27/30 for people whose highest level of education was high school, and 25/30 for people who did not complete high school).
* Able and willing to give written informed consent.

Exclusion Criteria:

* On any opioid for breathlessness in the previous seven (7) days.
* On regularly prescribed opioid medications for other conditions, including codeine preparations at or above 8mg oral morphine equivalent daily dose (MEDD) in the previous seven (7) days.
* History of adverse reactions to any of the study medications or constituents in the placebo;
* Australian-modified Karnofsky performance score (AKPS) less than 50 at the beginning of the study.
* Respiratory or cardiac event in the previous one week (excluding upper respiratory tract infections). Illness must have resolved completely prior to baseline evaluation, as judged by the person's treating physician.
* Evidence of respiratory depression with resting respiratory rate \<8/min.
* Documented central hypoventilation syndrome.
* Current history of abuse of alcohol, or recent history of substance misuse.
* Uncontrolled nausea, vomiting or evidence of a gastrointestinal tract obstruction.
* Renal dysfunction with creatinine clearance calculated (MDRD) less than 20 mls/minute.
* Evidence of severe hepatic impairment defined as transaminases or bilirubin \>4x normal (Excluding Gilbert's syndrome)
* Pregnant or breastfeeding.
C: 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.
D: Inclusion Criteria:

* People diagnosed with COPD or diabetes type 2 who are predominantly treated in primary care and who benefit from more physical activity, will be included. -This means patients who do not comply with the Dutch Norm for Healthy Exercise (30 minutes activity per day of a moderate intensity during five days a week)
* Their age should be between 40-70 years to ensure homogeneity in the groups
* Additional inclusion criteria for the diabetes group are a recent (no longer than a year ago) HbA1c concentration of more than 7% / more than 53 mmol/mol and a body mass index of more than 25kg/m2

For the COPD group the following additional inclusion criteria apply:

-A clinical diagnosis of COPD according to the GOLD-criteria stage 1, 2 and 3 (post bronchodilator FEV1/IVC \<= 70% and FEV1 between 30 and 80% of the predicted value); at least six weeks respiratory stable and on a stable drug regimen

Exclusion Criteria:

-Patients older than 70 years are not included because of a bigger risk for co-morbidity and a higher chance of mobility problems (balance)

Answer: C