Digital health to support physical activity in lung transplant candidates
| ISRCTN | ISRCTN15628295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15628295 |
| Integrated Research Application System (IRAS) | 356471 |
| Central Portfolio Management System (CPMS) | 69286 |
| Grant Code | SBF0010\1061 |
| Sponsor | Northumbria University |
| Funder | Academy of Medical Sciences |
- Submission date
- 05/02/2026
- Registration date
- 09/04/2026
- Last edited
- 09/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Lung transplantation is a well-established treatment option for individuals with severe lung disease. Due to the shortage of donors, the demand for lung transplantation greatly exceeds the availability of donor lungs, resulting in extensive waiting times. In the final stages of these conditions, the lungs and muscles stop working as well as they should, causing symptoms that impact physical function and quality of life. As a result, people on the waiting list tend to be much less physically active, which can lead to deconditioning, more frequent hospital admissions, and worse outcomes after transplant.
To address this, we aim to see if a digital intervention incorporating an activity monitor, an interactive online platform and individualised remote support from a health professional could be a valuable intervention to empower individuals on the waiting list to increase physical activity in their everyday lives. The objective is to determine the feasibility of delivering this digital physical activity intervention in people on the waiting list for LTx and whether it has the potential to optimise health outcomes compared to usual clinical care.
Who can participate?
Adults aged 18 years and older who are on the waiting list for lung transplantation.
What does the study involve?
Participants will be randomly allocated (2:1) into the intervention group or usual care.
Participants assigned to the intervention group will receive a 12-week digital behaviour change intervention alongside their UC. This includes: 1) a wrist activity monitor, linked to 2) an interactive, personalised, web-based dashboard, displaying multiple dimensions of physical activity data with integrated behaviour change tools; 3) one-to-one support from a dedicated mentor (6 x 20-minute sessions). After the 12 weeks, participants will continue wearing the watch during follow-up (to 24 weeks) and will have the option to access the platform and the watch once the study finishes.
The other group will receive usual care only. Participants will receive the same activity monitor and will be asked to wear the activity monitor (displaying time only) for 24 weeks without access to the dashboard or mentor support. Upon study completion, the control group will be offered the full intervention.
All participants will complete assessments (remotely) at the start of the study (0 weeks), post-intervention (12 weeks), and follow-up (24 weeks), including questionnaires on quality of life, symptom burden and psychological well-being. A subset of participants will be invited to answer some questions in the form of a semi-structured interview to explore their experiences of the study and the digital intervention.
What are the possible benefits and risks of participating?
The digital physical activity programme is designed to help people improve their activity levels; however, benefits are not guaranteed. Individuals completing the study will have the option to keep their activity watch and access to the digital platform.
There are minimal risks to taking part in this study. There may be minor adverse reactions (e.g., muscle soreness) to the physical activity programme; however, the intervention is guided by trained healthcare professionals, and any increases in activity will be introduced gradually and tailored to fit participants' usual daily activities.
Where is the study run from?
The study is a collaboration between Northumbria University, Newcastle Hospitals NHS Foundation Trust and KiActiv. Northumbria University will be leading the study.
When is the study starting and how long is it expected to run for?
March 2026 to December 2027
Who is funding the study?
Academy of Medical Sciences (UK)
Who is the main contact?
1. Dr Emily Hume, e.c.hume@northumbria.ac.uk
2. Dr Nathan Skidmore, nathan.skidmore@northumbria.ac.uk
Contact information
Principal investigator
Northumbria University
Newcastle upon Tyne
NE1 8ST
United Kingdom
| e.c.hume@northumbria.ac.uk |
Scientific, Public
Northumbria University
Newcastle upon Tyne
NE1 8ST
United Kingdom
| nathan.skidmore@northumbria.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Enhancing physical activity and quality of life in lung transplant candidates through digital health: a feasibility study |
| Study objectives | To investigate the feasibility of randomising 45 lung transplant candidates to a study comparing a 12-week digital physical activity intervention to usual care. Feasibility will be evaluated in terms of: a) recruitment and b) retention, and acceptability evaluated in terms of c) intervention adherence and d) participants' experiences of participating in the study. |
| Ethics approval(s) |
Approved 24/09/2025, Wales Research Ethics Committee 1 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 785738; Wales.REC1@wales.nhs.uk), ref: 25/WA/0250 |
| Health condition(s) or problem(s) studied | Lung transplant |
| Intervention | Arm 1: Digital Physical Activity Intervention + Usual Care Participants assigned to the intervention group will receive a 12-week digital behaviour change intervention alongside their usual care. This includes: 1) A wrist activity monitor, linked to; 2) an interactive, personalised, web-based dashboard (KiActiv® Health), displaying multiple dimensions of physical activity data with integrated behaviour change tools; 3) one-to-one support from a dedicated mentor (6 x 20-minute sessions). After the 12-week intervention, patients will retain access to the dashboard and activity monitor for continued self-management to 24 weeks. Arm 2: Usual Care (UC) The control group will receive UC only. After 24 weeks, the control group will be offered the full intervention. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Feasibility will be assessed through: |
| Key secondary outcome measure(s) |
1. The amount, duration and intensity of physical activity undertaken will be assessed through device-based activity monitoring continuously over 24 weeks |
| Completion date | 01/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Candidates on the waiting list for lung transplant (LTx) with any underlying disease diagnosis 2. Aged 18 years or above |
| Key exclusion criteria | 1. Unable to speak or read English 2. No home internet 3. Presence of any other significant disease or disorder which, in the opinion of the researcher may affect the participant’s ability to participate in the study |
| Date of first enrolment | 09/04/2026 |
| Date of final enrolment | 01/10/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Newcastle upon Tyne
NE1 8ST
England
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
05/02/2026: Study's existence confirmed by the NIHR.
