Effect of high flow oxygen on exercise capacity in patients with interstitial lung diseases during an exercise test on a bicycle compared with the effect obtained using low flow oxyge

Not Applicable

Completed

• Conditions: Exercise tolerance in patients with interstitial lung diseases; Respiratory

• Registration Number: ISRCTN11247116
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study Completion: 2023-12-30
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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 80 years old will be recruited and with the ability to give informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise capacity assessed as endurance time (Tlim) during a constant work rate cycle test at 75% of the maximal work load (obtained beforehand from a CPET) at a single time point

Secondary Outcome Measures

Name	Time	Method
1. SpO2 measured using a pulse oximeter throughout the CPET performed the first day and during the 2 CWRET performed during the second day<br>2. Heart rate (bpm) measured using a pulse oximeter throughout the CPET performed the first day and during the 2 CWRET performed during the second day<br>3. Dyspnoea and leg fatigue measured using the Borg scale at before and after of each test