Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Establish the (Cost-)Effectiveness of an Interdisciplinary Community-based COPD Management Program Relative to Usual Care.
Brief Summary: There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung function, skeletal muscle weakness and weight loss are important determinants of impaired exercise performance, decreased quality of life and increased mortality. Based on earlier succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre developed an integrated, inter-disciplinary approach to the management of COPD including physical exercise, nutritional therapy, education, smoking cessation and psychological consultation. This COPD management program consists of a set of protocols that cover patient recruitment, diagnostic testing, treatment, follow-up and communication between professionals.

The exercise program and the nutitional therapy are carried out by local physiotherapists and dieticians working outside but in conjunction with the hospital. A program in such a setting could be substantially less expensive and certainly more easily accessible for many more patients than an inpatient or hospital-based outpatient rehabilitation program, as it is offered close to a patient's home. This study investigates the (cost-)effectiveness of the COPD management program compared to usual care in a randomized controlled trial.

Patients with moderate to severe COPD and a reduced exercise capacity during an incremental exercise test of less than 70% of predicted, are randomised to a treatment or a control group. The treatment group will participate in the COPD management program during the first 4 months after which they will be followed up for the remaining months. Both groups (n=100) are followed for 2 years and outcomes will be assessed at the beginning of the program, after 4, 12 and 24 months by disease-specific and generic measures of health status, body composition, skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility analysis with a two-year time horizon will be performed. The analysis is conducted from a societal perspectice, including the program costs and all COPD-related direct costs within and outside the healthcare sector ans costs of lost productivity.


Options:
A: 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
B: Inclusion Criteria:

* well informed and consenting person
* woman is old enough to procreate
* Assisted respiratory treatment at home for 3 months : oxygenotherapy \> 8 hours per day and/or assisted ventilation \> 6 hours per day.
* PaO2 without oxygenotherapy ≤ 8 kPa or 60 mmHg on ambient air at the beginning of assisted respiratory treatment.
* Affection : chronic obstructive bronchopneumopathy, diffuse bronchial dilatation, non neuromuscular restrictive syndrome (pulmonary diffuse infiltration, parietal lesion) obstructive and restrictive syndrome.
* malnourished person, one of following criteria :Body Mass Index ≤ 21kg/m2 or weight loss (10% of the previous weight) or non-fatty mass measured by 50 Hz impedancemetry ≤25th percentiles or ≤ 63% of ideal weight for women, ≤ 67% of ideal weight for men.

Exclusion Criteria:

* Sleep apnea with daytime drowsiness (drowsiness scale of Epworth \> 9/24)
* Known pathology that reduce the vital prognosis at 6 months (AIDS, cancer...).
* History of hormone dependent cancer ( breast cancer, prostate cancer), pathologic Prostate Specific Antigen.
* Inability to follow a rehabilitation program
C: Inclusion Criteria:

* Patients over the age of 50 with COPD
* Admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of COPD

Exclusion Criteria:

* Significant co-morbidity including severe heart disease and cancer
* Any condition that would preclude participation in the physical therapy component of a pulmonary rehabilitation programme, including musculoskeletal diseases
D: Inclusion Criteria:

* A diagnosis of COPD based on the GOLD staging of the disease
* Medical Research Council Score of 3 or Above
* Ability of mobilize independently
* Motivated to exercise independently

Exclusion Criteria:

* No evidence of COPD on spirometry
* Acute exacerbation within 4-6 weeks
* Evidence of Ischemic Heat Disease/acute changes on ECG
* Uncontrolled hypertension
* Insulin dependent diabetic
* Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course
* Fear of needles
* Lung Cancer
* Previous attendance at pulmonary rehabilitation

Answer: A