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:

* patients with moderate to severe COPD

Exclusion Criteria:

* requirement for oxygen therapy;
* presence of symptomatic cardiovascular diseases or severe systemic diseases limiting exercise capacity;
* use of medications affecting exercise responses;
* musculoskeletal conditions with exercise performance limitation; and
* impaired hearing or vision that affects subject's ability to follow the exercise training program.
B: Inclusion Criteria:

* Diagnosis of COPD, clinically stable for 1 month;
* Spirometry results showing at least mild disease (FEV1/FVC \< 70% and FEV1 \< 80% predicted after bronchodilator);
* ADL limited by dyspnea;
* Ability to speak English and sign consent form;
* Actively use computer and the Internet;
* Maintain O2 saturation \> 85% on \< 6 L/min of nasal oxygen during the six minute walk;
* Understands and is able to rate shortness of breath during exercise

Exclusion Criteria:

* Active symptomatic illness other than COPD;
* Formal pulmonary rehabilitation training in the past 6 months
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:

* Participants will have:

  1. a diagnosis of COPD which is clinically stable (including medications) for at least one month;
  2. spirometry results showing at least mild obstructive disease defined as post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio \<0.70 with FEV1\<80% predicted or post-bronchodilator FEV1/FVC ratio \<0.60 with FEV1\>80% predicted;
  3. ADL limited by dyspnea;
  4. a designated primary care physician;
  5. ability to speak English and sign consent form;
  6. actively using a computer and the Internet;
  7. no formal pulmonary rehabilitation training for at least 12 months;
  8. patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at \>80% on \<6L/min of nasal oxygen;
  9. understands how to and is able to rate their shortness of breath during exercise;
  10. age \> 40 years.

Exclusion Criteria:

* Subjects will be excluded if they have active symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease with known coronary artery or valvular heart disease, psychiatric illness, and neuromuscular disease).

Answer: C