Cardiopulmonary exercise testing for pulmonary rehabilitation and exercise tailoring for people with pulmonary fibrosis
| ISRCTN | ISRCTN16693859 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16693859 |
| Integrated Research Application System (IRAS) | 354740 |
| Protocol number | 24-25-39 |
| Sponsor | University of Exeter |
| Funder | NIHR Exeter Biomedical Research Centre |
- Submission date
- 25/06/2026
- Registration date
- 26/06/2026
- Last edited
- 25/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Interstitial lung diseases (ILDs) are a group of around 200 long-term lung conditions, which often lead to lung failure. Pulmonary rehabilitation is a mix of exercise, advice and education used to support people with these diseases to help maintain their lung function and quality of life. The main aim of this research project is to improve pulmonary rehabilitation practice for people with pulmonary fibrosis by using a tailored approach.
Who can participate?
Adult patients from the ILD Clinic at the Royal Devon and Exeter University Trust and the EPIC-PF PPIE group.
What does the study involve?
All participants will be provided with a project information pack to include all the relevant consent forms, study details and questionnaires.
A cardiopulmonary exercise test (CPET) will be performed to see if the tailored methods are suitable. Five minutes of unloaded cycling will also be used as a ‘warm up’ and ‘cool down’.
Study Visit 1: Participant characteristics and anthropometric measures will be recorded and added to their individual, anonymised study profiles. An incrementally ramped CPET will be conducted on an electronically braked cycle ergometer, which is linked to a metalyzer for breath-by-breath gas analysis and a 12-lead Electrocardiogram (ECG).
If deemed appropriate, the next phase of the project will consist of Study visit 2 and study visit 3. The same CPET set up from Study Visit 1 will be used.
Study Visit 2: a 10-minute bout of aerobic exercise at ‘below’ the participants’ gas exchange threshold. Five minutes of unloaded cycling will also be used as a ‘warm up’ and ‘cool down’.
Study Visit 3: a 10-minute bout of aerobic exercise at ‘above’ the participants’ gas exchange threshold.
After completion, a series of questionnaires will be provided so that people with PF can give their perspectives on a range of elements related to quality of life, behaviours and attitudes.
What are the possible benefits and risks of participating?
Benefits: Taking part will give participants the confidence to perform exercise as it will be tailored to their individual capabilities and hopefully benefit their health and quality of life. However, the participant may receive no personal benefit from their participation in the research.
Risks: All exercise carries a risk, whether this is serious adverse events during exercise and/or minor injuries. Each individual patient and session will be risk-assessed in an attempt to mitigate these risks. Furthermore, all participants will have clearance from their consultant to participate in the study, and all exercises will be supervised by a medical practitioner with experience working with this patient population.
Where is the study run from?
University of Exeter, UK.
When is the study starting and how long is it expected to run for?
June 2026 to June 2029
Who is funding the study?
NIHR Exeter Biomedical Research Centre, UK.
Who is the main contact?
Dr Owen Tomlinson, O.W.Tomlinson@exeter.ac.uk
Contact information
Public, Scientific, Principal investigator
University of Exeter, St Luke's Campus, Heavitree Road
Exeter
EX1 2LU
United Kingdom
| Phone | +44 01392727049 |
|---|---|
| O.W.Tomlinson@exeter.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Participant information sheet | 49790_PIS_v3_15April2026.pdf |
| Scientific title | Cardiopulmonary exercise testing for Pulmonary rehabilitation and Exercise Tailoring - for people with Pulmonary Fibrosis (CPET-PF) |
| Study acronym | CPET-PF |
| Study objectives | To explore if Cardiopulmonary Exercise Testing (CPET) can support tailored exercise prescription for patients with Pulmonary Fibrosis (PF). |
| Ethics approval(s) |
Approved 17/04/2026, Brighton and Sussex Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 020 7104 8202; brightonandsussex.rec@hra.nhs.uk), ref: 26/LO/0111 |
| Health condition(s) or problem(s) studied | Pulmonary fibrosis |
| Methodology | This is an observational study, consisting of three study visits: Visit 1: Baseline assessments and cardiopulmonary exercise test to determine gas exchange threshold (GET) and exercise capacity (VO₂peak) Visit 2: 10-minute exercise session below GET (‘moderate’ exercise). Visit 3: 10-minute exercise session above GET (‘heavy’ exercise). Each session includes a 5-minute warm-up and a 5-minute cool-down. Patient-reported experience measures (PREMs) and health-related quality of life (HRQoL) questionnaires will assess acceptability and perceived benefit. Visits 1, 2 and 3 will be separated by a minimum of 72 hours to allow sufficient recovery between exercise bouts. Visits 2 and 3 will be randomised; therefore, patients may perform 'moderate' first or 'heavy' first. The second bout will therefore be the condition that they have not already done. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 25/06/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 35 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Key inclusion criteria | 1. Confirmed diagnosis of PF 2. Aged 35 to 85 years 3. Able to provide informed consent/assent 4. Able to perform CPET |
| Key exclusion criteria | 1. Presence of severe co-morbidity limiting mobilisation or physical activity participation (e.g. Orthopaedic, cardiac or neurological condition) 2. Previous lung transplantation 3. Pregnancy |
| Date of first enrolment | 25/06/2026 |
| Date of final enrolment | 25/06/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Exeter
EX2 5DW
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 15/04/2026 | 25/06/2026 | No | Yes |
| Protocol file | version 2 | 20/02/2026 | 25/06/2026 | No | No |
Additional files
- 49790_PIS_v3_15April2026.pdf
- Participant information sheet
- 49790 _Protocol_v2_20Feb2026.pdf
- Protocol file
Editorial Notes
Protocol number: 24-25-39
