Fibrosing interstitial lung disease Respiratory
Conditions
Interventions
RECRUITMENT, CONSENT AND SCREENING
All Patients affected with interstitial lung diseases referred to the physiotherapy department to receive pulmonary rehabilitation in the Lothian region and Newcast
Sponsors
University of Edinburgh
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fibrosing lung disease on HRCT obtained from medical records, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >10%, performed within 24 months of screening visit Clinical stability concerning pulmonary infections or acute exacerbations within the previous four weeks of inclusion in the study. 2. Absence of recent Myocardial Infarction (within last 3 months), unstable angina, other significant cardiac problems, systolic blood pressure > 180 mmHg, diastolic blood pressure > 100 mmHg or tachycardia (higher than 100 bpm) 3. Absence of significant orthopaedic, neurological, cognitive and/or psychiatric impairment restricting mobility. 4. Not following any exercise programme in the last 3 months. 5.Participants between 18 and 85 years old will be recruited with the ability to give informed consent. 6. TLCO = 25% and = 80% predicted. FVC (or VC) = 45% 7. Patients that experience a drop in oxygen saturation with the exercise below 90%
Exclusion criteria
Exclusion criteria: 1. Emphysema greater than extent of fibrosis on high resolution computed tomography (HRCT) of the thorax. 2. FEV1/FVC ratio < 70%. 3. Involvement in the planning and/or conduct of the study. 4. Participants should not be taking part in other interventional studies. 5. Patient is unable to attend the assessment sessions or would like to withdraw from the study. 6. Absolute contraindications for cardiopulmonary exercise testing, which are: 6.1. Unstable angina 6.2. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise. 6.3. Syncope. 6.4. Active endocarditis. 6.5. Acute myocarditis or pericarditis. 6.6. Symptomatic severe aortic stenosis. 6.7. Uncontrolled heart failure. 6.8. Acute pulmonary embolus or pulmonary infarction. 6.9. Thrombosis of lower extremities. 6.10. Suspected dissecting aneurysm. 6.11. Uncontrolled asthma. 6.12. Pulmonary edema. 6.13. Room air desaturation at rest = 85% 6.14. Respiratory failure. 6.15. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis) 6.16. Mental impairment leading to inability to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise Capacity, which will be assessed as endurance time (Tlim) during a constant work rate cycle test at 75% of the maximal workload (obtained beforehand from a maximal CPET). This outcome will be measured at baseline and after 8 weeks of the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical activity levels in daily life using Actigraph GT3x activity monitor. This outcome will be measured at baseline and after 8 weeks of the intervention. 2. Quadriceps muscle strength through the quadriceps maximal voluntary contraction test (QMVCT). This outcome will be measured at baseline and after 8 weeks of the intervention. 3. Quality of life using IPF-specific version of the St George’s Respiratory Questionnaire (SGRQ). This outcome will be measured at baseline and after 8 weeks of the intervention. 4. Anxiety and depression levels through the Hospital Anxiety and Depression Scale (HADS). This outcome will be measured at baseline and after 8 weeks of the intervention. 5. Dyspnoea through the Modified version of the Medical Research Council scale (mMRC). This outcome will be measured at baseline and after 8 weeks of the intervention. 6. Blood biomarkers associated with fibrosis (Inc but not restricted to PAI-1, VEGF-A, PDGF-AA, PDGF-BB, Cystatin-C, Angiopotein-1, HE4/WFDC-2). This outcome will be measured at baseline and after 8 weeks of the intervention. 7. The number of patients using anti-fibrotic medication will also be assessed. 8. We will also assess if the patients who are in treatment with antifibrotic medicines have better results than those who are not in treatment with antifibrotic medicines. | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactJaime Ricardo Jimenez Salazar
Outcome results
None listed