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The validity of performance tests, the 4 meter gait speed and the 5 repetitions sit to stand test, in patients suffering PF in daily clinical practice

Completed
Conditions
lung fibrosis
Pulmonary fibrosis
10038716
Registration Number
NL-OMON42289
Lead Sponsor
Sint Antonius Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

Patients with PF, visiting outpatient respiratory clinic at St Antonius Hospital in Nieuwegein (Expertise Centre Interstitial Lung disease, cIL) for routine medical control

Exclusion Criteria

Absolute contraindications
Acute myocardial infarction (3-5 days); Unstable angina; Uncontrolled arrhythmias causing symptoms or haemodynamic compromise; Syncope; Active endocarditis; Acute myocarditis or pericarditis; Symptomatic severe aortic stenosis; Uncontrolled heart failure; Acute pulmonary embolus or pulmonary infarction; Thrombosis of lower extremities; Suspected dissecting aneurysm; Uncontrolled asthma; Pulmonary oedema; Acute respiratory failure; Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis); Mental impairment leading to inability to cooperate;A subject that meets any of the following criteria, will be in- or excluded by the judge of the pulmonologist:;Relative contraindications
Room air SpO2 at rest 85% (arterial oxygen saturation measured by pulse oximetry); Left main coronary stenosis or its equivalent; Moderate stenotic valvular heart disease; Severe untreated arterial hypertension at rest (200 mmHg systolic, 120 mmHg diastolic); Tachyarrhythmias or bradyarrhythmias; High-degree atrioventricular block; Hypertrophic cardiomyopathy; Significant pulmonary hypertension; Advanced or complicated pregnancy; Electrolyte abnormalities; Orthopaedic impairment that prevents walking

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameters are:<br /><br>4MGS - the maximum gait speed in meters per second (m/sec).<br /><br>5STS - the shortest time (seconds) required to stand five times from sitting in<br /><br>a chair.<br /><br>6WMT - the maximum walking distance (meters). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>• SF-36 (IPF): 8 dimensions of Health-related quality of life.<br /><br>• MRC: a self administered questionnaire about perceived breathlessness.<br /><br>• Self efficacy: self reported activity limitation<br /><br>• Borg dyspnoe and Borg fatigue<br /><br>• Pulmonary function, baseline pulmonary test results: FVC, FEV1, DLCO<br /><br>• Oxygen saturation<br /><br>• Blood pressure (systolic/diastolic).<br /><br>• Body Mass Index (height / weight*weight).<br /><br>• Lean Body Mass (subtracting body fat weight from total body weight).<br /><br>• Grip strength (Jamar dynamometer).<br /><br>• Feasibility of performance tests (Likert scale), patient experience.<br /><br>• Utility of performance tests (Likert scale), assessor experience.</p><br>
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