Please select the eligibility criteria that correspond to the clinical trial below.
Title: Influence of Training With Whole Body Vibration Device (Galileo) on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH). (GALILEO PAH)
Brief Summary: Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.


Options:
A: * INCLUSION CRITERIA:

PH and ILD-only Groups: Subjects of this study will include individuals with ILD and PH who are referred for Pulmonary Rehabilitation. Patients with ILD, PH or PH comorbid with ILD will be included. The following list provides more specific inclusion criteria:

* Between age 21-82 years
* WHO functional class II or III, will accept WHO functional class I and IV based on 6 minute walk test results (less than or equal to 400 meters for Class I and greater than or equal to 50 meters for Class IV)
* No recent syncope or significant chest pain
* No prior Pulmonary Rehabilitation received within the last 6 months.
* Physically inactive, no participation in a structured exercise program 3 or more days a week for over 30 minutes at each session including pulmonary rehabilitation maintenance within the last 6 months.
* Patients may qualify if they have any one of the following conditions:

  * PAH diagnosed by right heart catheterization defined as resting pulmonary mean arterial pressure equal to or higher than 25 mmHg
  * Interstitial lung disease, including idiopathic pulmonary fibrosis (IPF), non-specific pulmonary fibrosis (NSPF), sarcoidosis or other form of chronic lung fibrosis will be based on clinical context via clinic note from primary pulmonologist and an echo within one year of enrollment showing an RVSP \<40mmHg.

    1. If RVSP is lower than 40mmHg patients with interstitial lung disease will be enrolled without the need for a right heart catheterization.
    2. If RVSP is indeterminate on an echo procedure performed within a year of enrollment, the patient will undergo another echo test at The National Institutes of Health, Echocardiogram Laboratory.
    3. Only if RVSP is unable to be estimated on an echo at NIH, the absence of the following abnormalities on echo will be used: right ventricular enlargement, right ventricular hypertrophy, paradoxical movement of interventricular septum and/or altered pulmonary flow velocity. If RVSP is unable to be estimated and these abnormalities are absent on echo, the patient will be enrolled as an ILD-only patient. If any of these echocardiographic abnormalities are present the patient will not be enrolled until the results of a right heart catheterization can be obtained to verify the absence of pulmonary hypertension.

Healthy Controls: The controls will include individuals who have never been diagnosed with primary or secondary PH and are apparently healthy. Controls will be matched to the PH cohort for age, gender, and body mass.

* Between 21 82 years
* Physically inactive, no participation in a structured exercise program 3 or more days a week for over 30 minutes at each session.
* No cardiorespiratory or pulmonary disease
* No other diseases of the neurological, metabolic, renal, or musculoskeletal system
* No medications that would influence aerobic capacity or treadmill performance

EXCLUSION CRITERIA FOR PATIENTS WITH PH, ILD-ONLY AND HEALTHY CONTROLS:

Since the goal is to examine exercise responses and adaptations as affected by PH, patients will have no other (except the primary disease in those with secondary PH) medical conditions that would impair aerobic capacity or the ability to engage in physical activity. These conditions would include any of those affecting the cardiovascular, pulmonary, metabolic, neurological, or musculoskeletal systems. Specific exclusion criteria for the PH and control cohorts are:

* Significant Restrictive or Obstructive Lung Disease with a FEV1/FVC ratio less than or equal to 65 percent
* Diagnosis of ischemic heart disease
* Left ventricular dysfunction with the ejection fraction less than 40 or a documented pulmonary capillary wedge pressure greater than or equal to 18 mmHg.
* Acute cor pulmonale
* Dilated or hypertrophic cardiomyopathy
* Non-idiopathic cardiomyopathy
* Significant hepatic or renal dysfunction
* Metastatic cancer with a life expectance of less than 6 months
* Disabling stroke
* Active substance abuse
* Severe psychiatric disease
* Patients on Antiretroviral Therapy
* Uncontrolled diabetes mellitus with a history of DKA
* Mitochondrial disease
* Pregnancy
* Ongoing tobacco use
* Children: Individuals younger than 21 years will not be included in the protocol because reference ranges for normative aerobic capacity and aerobic fitness have not been established for these age ranges.
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:

* Newly diagnosed or previously diagnosed patients with WHO Group I PAH.
* Documentation of the following hemodynamic parameters by right heart catheterization, performed at any time prior to study enrollment:
* Mean pulmonary arterial pressure (mPAP) \>25 mm Hg at rest or mPAP \> 30 mm Hg with exercise contemporaneous with a pulmonary wedge pressure ≤ 18 mm Hg
* Pulmonary wedge pressure ≤ 18 mm Hg
* Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (i.e., ≥ 3.0 Wood units)

Exclusion Criteria:

* Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V
* Have not had documentation of hemodynamic criteria for PAH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PAH.
* Do not meet the required hemodynamic criteria for entry into the study
D: Inclusion Criteria:

* Men and women age 18-90 years
* Signed informed consent
* Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
* Invasively confirmed PAH
* 6MWT ≥ 50 m
* Stable specific therapy for at least 2 months
* Ability to perform bike test
* Ability to perform wbv training
* NYHA/WHO-FC II-III

Exclusion Criteria:

* any other PAH/PH than idiopathic, hereditary or associated with systemic scleroderma
* Rehabilitation or other training concept performed within 2 months before inclusion
* pregnancy
* acute thrombosis
* newly implanted Hip or Knee
* recent bone fracture
* Disability to confirm consent
* NYHA/WHO-FC IV

Answer: D