An interventional study of I-IMPACT and Pulmonary Rehabilitation in Interstitial Lung Disease (ILD), sponsored by University Hospitals, Leicester. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University Hospitals, Leicester · Not applicable, Interventional, and Treatment
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.
Pulmonary rehabilitation (PR) is a recommended treatment for people living with long-term lung conditions such as Interstitial Lung Disease (ILD). The programme helps improve physical ability, symptom management, the ability to carry out everyday activities and mood. Standard programmes are typically delivered twice a week for 6-8 weeks at a hospital or community centre and include tailored exercise and education.
However, attending twice-weekly in-person sessions can be challenging for some individuals due to their symptoms, travel difficulties, or other commitments. To improve access, the University Hospitals of Leicester NHS Trust has developed a digital rehabilitation programme called I-IMPACT, which enables people to participate in rehabilitation from home using a computer, smartphone, or tablet. The platform includes a patient-facing website and an administrative website.
The I-IMPACT patient website includes:
The study aims to assess whether it is feasible (practical and acceptable) to compare I-IMPACT with a traditional in-person PR programme for people with ILD. In addition, health outcomes, including physical ability, breathlessness, quality of life, mood and safety, will be evaluated.
Participants will be randomly assigned to either I-IMPACT or an in-person programme and will complete assessments at baseline, immediately after the programme, and at six months. Participants will also have the opportunity to take part in two optional interviews.
Healthcare professionals will be invited to complete a questionnaire and an optional interview exploring their views on digital PR and I-IMPACT.
The findings will help determine whether a larger study can be conducted and whether I-IMPACT could be a safe and effective alternative to traditional in-person PR programmes.
680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →University Hospitals, Leicester is the lead sponsor of 68 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient participants:
Staff participants:
Exclusion Criteria:
Patient participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: I-IMPACT
Other: Pulmonary Rehabilitation
I-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.
An 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
Time frame: Patients: Recruitment monitored over a 12-month recruitment phase. Attrition, adherence and acceptability assessed at baseline, week 8 and 6 months. Staff: Acceptability assessed at any single time-point during the study.
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)
Time frame: Baseline, Week 8, and 6-month follow-up
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
Time frame: Baseline, Week 8, and 6-month follow-up
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)
Time frame: Baseline, Week 8, and 6-month follow-up
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)
Time frame: Baseline, Week 8, and 6-month follow-up
Health-Related Quality of Life - King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
Health-related quality of life will be assessed using the King's Brief Interstitial Lung Disease Questionnaire (K-BILD). Unit of Measure: Total score (0-100)
Time frame: Baseline, Week 8, and 6-month follow-up
Health-Related Quality of Life - Chronic Airways Assessment Test (CAAT)
Health-related quality of life will also be assessed using the Chronic Airways Assessment Test (CAAT). Unit of Measure: Total score (0-40)
Time frame: Baseline, Week 8, and 6-month follow-up
Health-Related Quality of Life - EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Health-related quality of life will also be assessed using the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L). Unit of Measure: Index Value
Time frame: Baseline, Week 8, and 6-month follow-up
Psychological Health - Patient Health Questionnaire-9 (PHQ-9)
Psychological health will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Unit of Measure: Total score (0-27)
Time frame: Baseline, Week 8, and 6-month follow-up
Psychological Health - Generalised Anxiety Disorder-7 (GAD-7)
Psychological health will also be assessed using the Generalised Anxiety Disorder-7 questionnaire (GAD-7). Unit of Measure: Total score (0-21)
Time frame: Baseline, Week 8, and 6-month follow-up
Physical Activity
Physical activity will be assessed using a wrist-worn GENEActiv accelerometer provided to participants at each assessment visit. Unit of Measure: Average daily physical activity
Time frame: Baseline, Week 8, and 6-month follow-up
Incidence and Nature of Adverse Events
The incidence and nature of adverse events will be recorded throughout the study. Participants will be asked about adverse events at the Week 8 and 6-month follow-up assessments and can report events directly to the research team throughout the study. Participants allocated to the I-IMPACT arm will also receive fortnightly telephone check-ins during which safety events may be reported. Hospital records will be reviewed, where appropriate, to verify reported events. Unit of Measure: Incidence and nature of adverse events
Time frame: Baseline through 6-month follow-up
No study locations are listed for this record.
Plan to share: No
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University Hospitals, Leicester