Interstitial Lung Disease (ILD)I-IMPACT ILDNCT07780201
Feasibility, Acceptability, and Implementability of I-IMPACT for ILD
A study testing I-IMPACT and Pulmonary Rehabilitation in people with Interstitial Lung Disease (ILD), run by University Hospitals, Leicester.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- I-IMPACT and Pulmonary Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 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.
- Digital access: able to access and use the internet and an internet-enabled device to engage with I-IMPACT.
Show all 13Show fewer
- Language: able to read and write in English to complete the programme and study assessments.
- Randomisation: willing to be randomised to either arm
- Staff participants:
- Consent: willing and able to provide informed consent to participate in the study
- Professional role: a qualified healthcare professional involved in delivering ILD care and/or pulmonary rehabilitation (PR) at the UHL NHS Trust or another healthcare organisation.
- Employment duration (UHL staff only): must have been employed by the UHL NHS Trust for at least two years.
- Language: able to read and write in English to complete the acceptability questionnaire and optional interview.
Who cannot join
- Patient participants:
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility, Acceptability, and Implementability of an Asynchronous Digital Pulmonary Rehabilitation Programme (I-IMPACT) Compared With Centre-Based Pulmonary Rehabilitation in Adults With Interstitial Lung Disease.
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.
Read the detailed description
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:
- Health information
- Exercise resources with step-by-step video demonstrations
- Symptom trackers
- Goal-setting features
- Support from the clinical and IT team
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.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- I-IMPACT, Pulmonary Rehabilitation
- Keywords
- Interstitial lung disease (ILD), I-IMPACT, feasibility, digital pulmonary rehabilitation, Randomised controlled trial, Implementation
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-IMPACTDevice
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.
Pulmonary RehabilitationOther
An outpatient pulmonary rehabilitation programme delivered at the UHL NHS Trust. This is an 8-week, twice-weekly supervised programme at Glenfield Hospital.
| Study group | Role | What they receive |
|---|---|---|
| I-IMPACT | Experimental | Not described Receives: Device: I-IMPACT |
| Usual Care | Active comparator | Not described Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Secondary outcomes (11)
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline through 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780201
- Sponsor's protocol ID
- 370102
- Acronym
- I-IMPACT ILD
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Implementability of an Asynchronous Digital Pulmonary Rehabilitation Programme (I-IMPACT) Compared With Centre-Based Pulmonary Rehabilitation in Adults With Interstitial Lung Disease.
- ClinicalTrials.gov ID
- NCT07780201
- Acronym / sponsor ID
- I-IMPACT ILD / 370102
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- Interstitial lung disease (ILD), I-IMPACT, feasibility, digital pulmonary rehabilitation, Randomised controlled trial, Implementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Health information
- Exercise resources with step-by-step video demonstrations
- Symptom trackers
- Goal-setting features
- Support from the clinical and IT team
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-IMPACT | Experimental | Device: I-IMPACT |
| Usual Care | Active comparator | Other: Pulmonary Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Digital access: able to access and use the internet and an internet-enabled device to engage with I-IMPACT.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-IMPACTI-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. | Device | I-IMPACT |
| Pulmonary RehabilitationAn outpatient pulmonary rehabilitation programme delivered at the UHL NHS Trust. This is an 8-week, twice-weekly supervised programme at Glenfield Hospital. | Other | Usual Care |
Primary outcome
Feasibility of the programme and conducing the RCT
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.
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
11 secondary outcomes
Functional Exercise Capacity - Incremental Shuttle Walk Test (ISWT)
Time frame: Baseline, Week 8, and 6-month follow-up
Functional Exercise Capacity - 1-Minute Sit-to-Stand Test (1-MSTST)
Time frame: Baseline, Week 8, and 6-month follow-up
Functional Exercise Capacity - Endurance Shuttle Walk Test (ESWT)
Time frame: Baseline, Week 8, and 6-month follow-up
Dyspnoea
Time frame: Baseline, Week 8, and 6-month follow-up
Health-Related Quality of Life - King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
Time frame: Baseline, Week 8, and 6-month follow-up
Health-Related Quality of Life - Chronic Airways Assessment Test (CAAT)
Time frame: Baseline, Week 8, and 6-month follow-up
Health-Related Quality of Life - EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time frame: Baseline, Week 8, and 6-month follow-up
Psychological Health - Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, Week 8, and 6-month follow-up
Psychological Health - Generalised Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, Week 8, and 6-month follow-up
Physical Activity
Time frame: Baseline, Week 8, and 6-month follow-up
Incidence and Nature of Adverse Events
Time frame: Baseline through 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Interstitial Lung Disease (ILD)
RecruitingPhase 2
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
Active, not recruitingObservational study
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
Pulmonary Hypertension, Interstitial Lung Disease
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing I-IMPACT and Pulmonary Rehabilitation in people with Interstitial Lung Disease (ILD), run by University Hospitals, Leicester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enya Daynes, PhD (0116 250 2759, e.daynes@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the programme and conducing the RCT (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.