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.
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.
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).
Parallel
I-IMPACT
DeviceI-IMPACT (Individualised self-Management ProgrAmme for long-term CondiTions) is a digital self-management rehabilitation programme developed by the UHL NHS Trust. The programme is designed for individuals recovering from acute illness and those living with chronic respiratory and cardiac conditions. For this study, the programme will be set so that each participant's primary diagnosis is ILD. I-IMPACT delivers physical and psychological support through a comprehensive set of features. Participants allocated to the I-IMPACT programme will be able to: * Access educational material, both general and diagnosis-specific. * Record cardiovascular and strength exercise sessions. * Update their symptoms using the health trackers. * Create and review personalised goals. * Contact their rehabilitation team via the "Ask a Healthcare Professional" feature. * Contact technical support for any IT or navigation challenges.
Pulmonary Rehabilitation
Other interventionAn outpatient pulmonary rehabilitation programme delivered at the UHL NHS Trust. This is an 8-week, twice-weekly supervised programme at Glenfield Hospital.
Feasibility of the programme and conducing the RCT
The primary objective is to determine the feasibility of delivering I-IMPACT and of conducting this RCT, with primary endpoints including patient recruitment, attrition, adherence and programme acceptability evaluated from both patient and healthcare professional (HCP) perspectives
Functional Exercise Capacity - Incremental Shuttle Walk Test (ISWT)
Functional exercise capacity will be assessed using the Incremental Shuttle Walk Test (ISWT). Unit of Measure: Distance (metres)
Functional Exercise Capacity - 1-Minute Sit-to-Stand Test (1-MSTST)
Functional exercise capacity will also be assessed using the 1-Minute Sit-to-Stand Test (1-MSTST). Unit of Measure: Number of completed repetitions
Functional Exercise Capacity - Endurance Shuttle Walk Test (ESWT)
Functional exercise capacity will also be assessed using the Endurance Shuttle Walk Test (ESWT). Unit of Measure: Time (seconds)
Dyspnoea
Dyspnoea will be assessed using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ). Unit of Measure: Total score (0-120)
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