Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase II Pilot Pragmatic Single-Blinded Fast Track Randomised Controlled Trial of the Breathlessness Intervention Service Versus Standard Care for Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The aim of this study is to test the feasibility of conducting a pragmatic fast track Randomized Controlled Trial (RCT) of the Breathlessness Intervention Service (BIS) versus standard care for patients with COPD and their carers, and to begin testing the effectiveness of the intervention.


Options:
A: Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease
* Resting Dyspnea \> 2 OR Activity Dyspnea \> 4 in the prior 4 weeks to screening

Exclusion Criteria:

* Cognitive impairment on the 10-item Short Portable Mental Status Questionnaire
* History of serious psychiatric illness
* Unwilling or unable to participate in the full eight week program and evaluation
B: Inclusion Criteria:

* Patients with stable mild-to-moderate COPD (Both stages: FEV1/FVC \< 70%. Mild stage: FEV1 ≥ 80% predicted; Moderate stage: 50% ≤ FEV1 \< 80% predicted according to Global Initiative Obstructive Lung Disease (GOLD) guideline).
* Free of exacerbations for more than 4 weeks (as defined by a change to pharmacological therapy, admission to hospital or ER or unscheduled clinic visit).
* Good communication

Exclusion Criteria:

* Older than 70 years old
* Musculoskeletal problems that limit mobility
* Cardiovascular disease
* Neurological or psychiatric illness
* Patient on long term oxygen or domiciliary noninvasive positive pressure ventilation
* Any other comorbidities which would affect ability to undertake exercise test
C: Inclusion Criteria:

Patients:

* Appropriate referral to the BIS
* Diagnosis of COPD/COAD
* Aged 18 years or over
* Any patient who does not meet any of the exclusion criteria

Carers:

* The informal carers of patients specified above, who can be significant others, relatives, friends or neighbours
* Aged 18 years or over
* Any carer who does not meet the exclusion criteria

Exclusion Criteria:

* Any patient/carer unable to give informed consent
* Any patient living outside of Cambridgeshire PCT, West Essex PCT, East \& North Hertfordshire PCT, or Suffolk PCT
* Any patient who has previously had access to BIS
* Any patient/carer who is demented or confused
* Any patient/carer with learning difficulties
* Any patient/carer from other vulnerable groups (e.g. head injury, severe trauma, and mental illness)
* Any patient/carer who does not meet all of the inclusion criteria
D: Inclusion Criteria: (1) age between 50 and 80 years; (2) a post-bronchodilator forced expiratory volume in one second (FEV1) \< 80% of the predicted value and a FEV1/ forced vital capacity (CVF) ratio \< 0,7; (3) stable respiratory/clinical condition without changes in medication and symptoms (dyspnea, volume or color of sputum) for at least 4 weeks before admission to the study; and (4) receiving regular treatment with inhaled bronchodilators and steroids.

Exclusion Criteria: (1) presence of other pulmonary, cardiovascular or musculoskeletal diseases; (2) previously participation in any exercise-training program in the last 2 years before participating in this study; and (3) current smokers.

Answer: C