Table 1.
Assessment/procedure | Enrolment | Baseline | Allocation | 3-month follow-up | 6-month follow-up |
Informed consent | x | ||||
Randomisation (oxygen or air group) | x | ||||
Resting arterial blood gas (if SpO2 <93%) | x | ||||
StepWatch activity monitor (for 7 days) | x | x | x | ||
Physical activity level (GENEActiv) (for 7 days) | x | x | x | ||
Oxygen saturation in daily life (for 2 days) | x | x | x | ||
6-minute walk test | x | x | x | ||
HRQL–SGRQ, K-BILD, EQ-5D-5L | x | x | x | ||
Dyspnoea-12 | x | x | x | ||
Fatigue Severity Questionnaire | x | x | x | ||
Anxiety/depression (HADS) | x | x | x | ||
Biochemical analysis | x | x | x | ||
Portable oxygen concentrator usage (hours) | x | x | |||
Patient telephone calls (monthly) | x | x | x | ||
Adverse events | x | x | |||
Economic evaluation | x |
HADS, Hospital Anxiety and Depression Scale; HRQL, health-related quality of life; K-BILD, King’s Brief Interstitial Lung Disease questionnaire; SGRQ, St George’s Respiratory Questionnaire; SpO2, oxyhaemoglobin saturation.