About this trial
This is a single-centre, two-arm randomised controlled feasibility trial comparing I-IMPACT, an asynchronous digital rehabilitation programme, with conventional centre-based pulmonary rehabilitation (usual care) in adults with Interstitial Lung Disease (ILD). The study will be conducted at the University Hospitals of Leicester NHS Trust, and Glenfield Hospital is the central site for participant recruitment, baseline and longitudinal assessments, and delivery of the in-person usual care arm.
This is a feasibility study; therefore, the primary outcome is feasibility (recruitment, attrition, adherence, and acceptability), and the secondary outcomes comprise preliminary clinical and safety parameters. Outcomes will be assessed through a mixed-methods approach, involving both ILD patients and staff (healthcare professionals) participants.
Eligibility criteria
Qualifiers
Age: ≥ 18 years
Consent: willing and able to provide informed consent to participate in the study
Diagnosis: physician-confirmed diagnosis of ILD of any subtype
Clinically stable: no ILD exacerbation or respiratory-related hospitalisation in the preceding four weeks.
Disqualifiers
Recent or concurrent PR: concurrent enrollment or recent completion of a PR programme within the 12-months preceding enrollment.
Contraindications to exercise: presenting with exercise-related contraindications (unstable cardiovascular disease; hypertension, etc., a full list is described by the American College of Sports Medicine and is routinely deployed).
Trial design
Treatments tested in this trial
- I-IMPACT
- Pulmonary Rehabilitation