Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension
Brief Summary: Background

-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.

Methods

-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.

Prospects

-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.


Options:
A: Inclusion Criteria:

* Patients who were clinically stable and compensated under optimized medical therapy
* World health organization (WHO) Classification of functional class II to III PAH
* Patients with ejection fraction ≥ 40%
* Non-smokers
* body mass index ≤ 35 kg/m2

Exclusion Criteria:

* Any patient with respiratory failure
* unstable angina
* renal, hepatic or neuromuscular disorders
* history of syncopal attacks
* uncontrolled systemic hypertension
* peripheral vascular disease
* serious cardiac dysrhythmias on resting ECG
* evidence of severe COPD at pulmonary function testing,
* any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise
B: Inclusion Criteria:

* Clinically stable
* Under standard medication
* Group 1 pulmonary arterial hypertension patients
* Having no exacerbation or infection

Exclusion Criteria:

* Cognitive disorders
* Orthopedic and neurological problems
* Pneumonia or acute infection
* Stage 4 heart failure
* Having no comorbidity to avoid performing evaluation and training
C: Inclusion Criteria:

1. Informed consent
2. Men and women 18 - 80 years
3. Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease)
4. Symptomatic PAH (WHO- functional class II-IV) invasively diagnosed by right heart catheterisation

   * Mean pulmonary artery pressure (mPAP) \> 25 mmHg
   * Pulmonary capillary wedge pressure (PCWP) \> 15 mmHg
   * Pulmonary vascular resistance (PVR) at baseline \>320 dyn.sec/cm5 patients under optimized medical treatment since at least 2 ½ months

Exclusion Criteria:

1. Other forms of PAH.
2. Pregnancy or lactation
3. Change in medication during the last 2 ½ months
4. Patients with signs of right heart decompensation
5. Severe impairment of walking
6. Unclear diagnosis
7. No invasive diagnosis of PH
8. Acute illness, infection, fever
9. Severe lung disease with FEV1 \<50% and TLC\< 70% below reference
D: Inclusion Criteria:

* Patients with severe chronic PH who were stable and compensated under optimized medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study will be invited to participate.

Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.

Exclusion Criteria:

* Patients with recent syncope or skeletal or muscle abnormalities prohibiting participation in an exercise program won't be included.

Answer: D