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
- Conditions
- lung fibrosisPulmonary fibrosis10038716
- 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
Patients with PF, visiting outpatient respiratory clinic at St Antonius Hospital in Nieuwegein (Expertise Centre Interstitial Lung disease, cIL) for routine medical control
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
Name Time Method <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
Name Time Method <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>