Lung CancerPReFACeNCT07554677
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
A study testing Exercise and radiotherapy in people with Lung Cancer, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to understand the feasibility of a co-designed, pre-radiotherapy exercise programme for people with stage I-III non-small cell lung cancer. This involves people with lung cancer engaging in 20 minutes exercises sessions performed within the radiotherapy department and immediately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Exercise and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2026to 14 Jan 2027
- 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
- Patients with clinically or histologically confirmed NSCLC stages 1-3.
- Planned to receive treatment with curative intention radiation as primary treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- At least 18 years of age.
- Can understand and communicate in English.
- Deemed safe to participate in moderate-intensity exercise and for ECG monitored maximal fitness test through the completion of a medical clearance form by their treating physician.
- Able to provide written and informed consent.
Who cannot join
- Unstable or new angina (diagnosed within the previous month).
- Unstable or acute heart failure, cardiomyopathy, or other uncontrolled cardiac disease (as evidenced by symptomatic fluid retention, excessive breathlessness, rapid weight gain, swollen ankles or pitting oedema) within the previous 3 months.
- Presence of new or uncontrolled cardiac arrhythmias.
- Confirmed or suspected spinal cord compression.
- Uncontrolled diabetes (e.g. medication changed within 1 month, has had episodes of hypoglycaemia during the previous 2 weeks, or hyperglycaemia which does not decrease with exercise during the previous 2 weeks).
- Is receiving combination treatment with chemotherapy or immunotherapy.
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- Current active secondary malignancy other than non-melanoma skin cancer.
- Has had orthopaedic surgery within the previous 3 months on weight-bearing bones.
- Chest pain while undertaking exercise or physical activity.
- No > Grade 2 peripheral neuropathy.
- Metastatic disease beyond localised metastatic involvement (e.g. bone or brain).
- Has discovered any abnormalities shown on the ECG monitored maximal fitness test which warrant early termination or contraindicate physical activity.
- People with living with a physical disability which would limit their ability to exercise safely on the stationary exercise bike used within this study.
- People who are non-English speakers.
- People who are pregnant.
- Patient participation in other clinical research - As an additional consideration, patients will be excluded if they are currently enrolled in an alternative exercise or physical activity study, as this may impact outcomes in both studies. However, if they have been involved in research prior to this or are currently involved in research in an unrelated area we will not immediately exclude them from trial participation. Instead, the Doctor of Philosophy (PhD) candidate, Chief investigator, and Principal investigator will discuss their involvement to determine safe and appropriate enrolment.
- Physical disability - it is with regret that we will be limited in our capacity to offer alternative exercises to accommodate people with a physical disability. To elaborate, the Belfast City Hospitals (BCH) main gym is willing to lend a stationary exercise bike to the research team in support of this study. However, due to limitations on equipment availability in the trust, and limited funding/resources to purchase equipment, people who have a physical disability which limits their capacity to exercise safely on the stationary bike will be excluded from this study. In an ideal scenario, we would also have a recumbent stationary bike to support more people with physical disability get involved within this research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Northern Ireland Cancer Centre, City Hospital, BHSCT
Belfast, Antrim, BT9 7JL
Matthew Peter Beggs, MSc, BSc, +44 7759264875, mbeggs06@qub.ac.uk
Cathryn Dr Crockett, Consultant Clinical Oncologist
About this study
Official title: Feasibility of a Co-designed PRe-radiotherapy Exercise Programme for People With Stage I-III Non-small Cell Lung cAnCEr: A Single-centre, Single Arm Pilot Study
The goal of this clinical trial is to understand the feasibility of a co-designed, pre-radiotherapy exercise programme for people with stage I-III non-small cell lung cancer. This involves people with lung cancer engaging in 20 minutes exercises sessions performed within the radiotherapy department and immediately before each treatment at a personalised intensity.
The main questions it aims to answer are:
Read more
To understand the acceptability of the exercise programme through monitoring recruitment rates, attendance of the exercise sessions, and adherence to prescribed exercise intensities. Adverse events will also be monitored to understand programme safety.
Follow-up qualitative interviews will be conducted with participants, their family members, and health care professionals (HCP) to further explore the acceptability of the exercise programme.
In total, participants will be invited to perform up to twenty, supervised exercise sessions scheduled immediately before each treatment within the radiotherapy department. Each exercise session will be twenty minutes in duration and will be performed on a stationary exercise bike. Regarding exercise intensity, there are four levels which may be prescribed depending on people's exercise history, baseline exercise experience, and personal preference. Participants may progress or regress exercise intensity levels throughout the programme depending on their adherence and preference.
Read the detailed description
This is a sequential, mixed method feasibility study consisting of two phases:
Phase 1: Quantitative data collection (feasibility outcomes)
Phase 2: Qualitative data collection (semi-structured interviews)
The exercise programme used in this study was co-designed through a series of workshops and meetings involving individuals affected by lung cancer and healthcare professionals.
Eligible participants must be receiving a prescribed radiotherapy dose of either 55 Gy delivered in twenty fractions or 66Gy administered in 15 fractions, adminstered daily over a 3-4 week period. Accordingly, participants will be prescribed either 15 or 20 exercise sessions, performed once daily and scheduled in alignment with their radiotherapy treatment.
Exercise intensity is personalised and based on a submaximal exercise test conducted at the participant's baseline assessment. This test will be used to determine each participant's maximum heart rate, which will then be entered into the Karvonen formula (Karvonen et al., 1957) to calculate percentage heart rate reserve. This calculation will establish individual heart-rate ranges corresponding to light, moderate, and vigorous exercise intensities. Starting exercise intensity level (1-4) will be determined based on a baseline six-minute walking test, clinical frailty score, and participant preference.
The four levels of exercise intensity increase in difficulty, and incorporate various durations of light, moderate, or high intensity exercise, including:
- Level 1: 10-minute warm-up at light intensity continuous cycling followed by 10 minutes of moderate intensity continuous cycling
- Level 2: 5-minute warm-up at light intensity continuous cycling followed by 15 minutes of moderate intensity continuous cycling
- Level 3: 5-minute warm-up at light intensity continuous cycling, followed by 10 minutes of moderate intensity continuous cycling, and 5 minutes of 30-second-high intensity intervals
- Level 4: 5-minute warm-up at light intensity continuous cycling, followed by 5 minutes of 30-second-high intensity intervals, 5 minutes of moderate intensity continuous cycling, and 5 minutes of 30-second-high intensity intervals
All participants will wear a chest-strap heart-rate monitor during each exercise session to ensure they are exercising at the prescribed intensity. Session adherence will be defined as completion of at least 75% of the prescribed exercise duration (i.e. 15-minutes).
- Conditions
- Lung Cancer
- Being tested
- Exercise, radiotherapy
- Keywords
- Radiotherapy, Clinical Trial, Exercise, Physical Activity, feasibility, co-design
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants will participate in up to twenty, supervised exercise sessions, performed within the radiotherapy department, immediately before each treatment. Each session has a 20 minute duration at one of four exercise intensity levels based on the participants baseline assessment results, and preferences.
radiotherapyRadiation
Study participants will have been diagnosed with stage I-III NSCLC and prescribed radiotherapy administered as 55Gy in 20 fractions over 4 weeks or 60Gy in 15 fractions over 3 weeks as their primary treatment as per standard treatment pathways within the trust
| Study group | Role | What they receive |
|---|---|---|
| Pre-Radiotherapy exercise arm | Experimental | Participants within the experimental arm will participate in the co-designed, pre-radiotherapy exercise programme alongside treatment. Receives: Other: Exercise; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rates
The percentage of eligible participants identified and approached through participant screening
Measured: Screening and enrolment
Recruitment rate
The total number of potential participants who were approached and agreed to participate as a percentage of the total number who were approached
Measured: Screening and recruitment
Exercise programme attendance
The total number of attended sessions by the total number provided
Measured: Weeks 4-8 (PReFACe exercise programme)
Adherence to the exercise programme
Monitoring the participants ability to complete the advised duration and intensity of exercise during each session (adherence is accepted if completed 75% of duration without intensity modification)
Measured: Weeks 4-8 (PReFACe exercise programme)
Participant retention rates
The number of participants available to provide outcomes at the post-intervention assessment as a percentage of the total number recruited.
Measured: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)
Adverse event Common Terminology Criteria for Adverse Events (CTCAE) v5
Assess the tolerability and safety of the intervention, via recording of intervention-associated adverse events (AE). AEs will be graded according to CTCAE v.5 as:
- Grade 1 = Mild
- Grade 2 = Moderate
- Grade 3 = Severe
- Grade 4 = Life-threatening consequences
- Grade 5 = Death related to AE
Measured: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)
Secondary outcomes (12)
Change from baseline in quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-items (EORTC QLQ-30)
EORTC QLQ-30 is a reliable and validated, multidimensional quality-of-life questionnaire which is widely used in research for people with lung cancer.
The QLQ-C30 is composed of both multi-item scales and single-item measures, including:
Five functional scales:
- Physical
- Role
- Emotional
- Cognitive
- Social
Three symptoms' scales:
- Fatigue
- Nausea and Vomiting
- Pain
A Global health Status (QoL)
Six single items:
- Dyspnoea
- Insomnia
- Appetite loss
- Constipation
- Diarrhoea
- Financial difficulties
All scales and single-item measures range in score from 0 to 100. High scale scores represent a higher response level, thus:
- High scores for functional sales = high/healthy levels of functioning
- High global health status = high QoL
- High symptom scale/ single item scores = higher symptom burden
Measured: Week 0 (baseline assessment) to week 8 (end of study assessment)
Change from baseline in quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)
EORTC QLQ-LC13 is a reliable and validated, multidimensional quality-of-life questionnaire which is widely used in research for people with lung cancer.
The QLQ-LC13 incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing:
- Pain
- Coughing
- Sore mouth
- Dysphagia
- Peripheral Neuropathy
- Alopecia
- Haemoptysis
All single-item measures range in score from 0 to 100 with high scale scores representing a higher response level, thus:
- High symptom scale/ single item scores = higher symptom burden
Measured: Week 0 (baseline assessment) to week 8 (end of study assessment)
Impact of exercise programmes effect on symptom burden: Pain likert Scale
Understanding the impact of the exercise programme on symptom burden on participants experience of pain using a 1-10 likert scale:
- Scores 1-3 = Mild Pain
- Scores 4-7 = Moderate pain
- Scores 8-10 = Severe pain
Measured: Week 0 (baseline assessment) to week 8 (end of study assessment)
Impact of exercise programmes effect on symptom burden: Fatigue likert Scale
Understanding the impact of the exercise programme on symptom burden on participants experience of fatigue using a 1-10 likert scale:
- Scores 1-2 = No fatigue
- Scores 3-4 = Minor fatigue
- Scores 5-6 = Moderate fatigue
- Scores 7-8 = Significant fatigue
- Scores 9-10 = Extreme fatigue
Measured: Week 0 (baseline assessment) to week 8 (end of study assessment)
Impact of exercise programmes effect on symptom burden: Modified Medical Research Council (MRC) dyspnoea scale
The modified MRC dyspnoea scale is a 5-point (0-4) questionnaire that assesses a patient's breathing difficulty, or dyspnoea, during activity. Higher scores correspond with more breathlessness etc:
- grade 0 = breathless with strenuous exercise
- grade 1 = short of breath when hurrying on level ground or walking up a slight hill
- grade 2 = on level ground, I walk slower than people of my age because of breathlessness
- grade 3 = I stop for breath after walking about 100 yards or after a few minutes on level ground
- grade 4 = Too breathless to leave the house or I am breathless when dressing/undressing
Measured: Week 0 (baseline assessment), daily through PReFACe exercise programme (weeks 4-8) and end of study assessment (week 8)
To assess the accessibility, acceptability and experience of the exercise programme through semi-structured qualitative interviews
Conduct of post-intervention, semi-structured, qualitative interviews with the following groups:
- Phase 1 participants (who have completed the programme or withdrew from the programme)
- Phase 1 participants nominated person (friend or family)
- Healt Care Professionals (HCPs) involved/ exposed to the study
A total of 15 participants (n=5 from each group) is deemed sufficient to achieve data saturation.
Semi-structured interview schedules were pre-constructed for each group.
Interview schedules consist of open-ended questions to explore the participants/experience of the exercise programme in their own words.
No scales are used as a part of this outcome.
Measured: Weeks 8-14 post-intervention follow-up period
Baseline compared to post-intervention changes in participant distress levels using the National Comprehensive Cancer Network (NCCN) Distress thermometer.
The distress thermometer is a valid, and accurate screening tool used to quickly monitor for patient's distress with advanced cancer.
The thermometer uses a 0-10 scale to measure patient distress over the past week with 0 representing no distress and 10 representing extreme distress.
The thermometer also features a "Problem List" (covering practical, family, emotional, spiritual, and physical issues) to pinpoint causes of distress for referral
Measured: Baseline assessment (week 0), weekly throughout the PReFACe exercise programme (weeks 4-8) and at post-study assessment (week 8)
Change in baseline to post-intervention physical fitness: Six- minute walking test
A well-documented, validated and standardised sub-maximal fitness test measuring the distance a person can walk on a flat, solid surface in six minutes. Participants walk back and forth along a measured track to measure total distance covered in meters within six minutes.
Greater distance covered (meters) indicate greater baseline fitness.
Greater post-test distance covered (meters) than baseline scores indicate improvements in basic mobility.
Reduced post-test distance covered (meters) than baseline scores indicate reductions in basic mobility.
Measured: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical fitness: 30-second sit-to-stand
A well-documented, validated, and standardised test to measure functional lower extremity strength. Participants perform as many sit-to-stand reps as they can within 30 seconds.
Measured: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical functioning: Rockwood Clinical Frailty Scale (CFS)
The Rockwood CFS is used as a valid assessment tool for screening frailty in older adults. This is a 1-9 scale, with higher scores indicating greater frailty:
- Very fit
- Well
- Managing well
- Vulnerable
- Mildly frail
- Moderately frail
- Severely frail
- Very severely frail 9- Terminally ill
Measured: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical activity: The International Physical Activity Questionnaire - Short Form (IPAQ-SF)
The IPAQ-SF will be used to explore the influence of the pre-radiotherapy exercise programme on the participant's weekly physical activity levels pre- and post-study. Based on results, physical activity levels based on scores can be calculated as:
- Inactive
- Minimally active
- HEPA active (health enhancing physical activity; a high active category)
Measured: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical activity: Huffman Exercise Satisfactions Scale
The Huffman Exercise Satisfaction Scale was developed with stakeholders as a novel approach to measure older adults (aged ≥55 years) satisfaction with their physical activity levels.
There questionnaire measures two scales:
- A Physical activity enjoyment scale, consisting of 8 multiple choice questions. Responses are allocated a range from 1 to 7 with higher values indicate higher levels of enjoyment of physical activity
- Satisfaction measure, consists of 4, multiple choice questions. Responses to the satisfaction items range from 1 to 7, with higher values indicating higher levels of satisfaction with physical activity.
Mean scores are taken from each scale to total participants exercise enjoyment and satisfaction.
Measured: Baseline assessment (week 0) and post-study assessment (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start2 Jun 2026
- Primary completion14 Jan 2027 (estimated)
- Study completion14 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (69)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gillian Prue, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554677
- Sponsor's protocol ID
- 350051
- Other IDs
- 25017GP-SS
- Acronym
- PReFACe
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently under review with supervisory team
Publications
Ziolkowska-Suchanek I. Mimicking Tumor Hypoxia in Non-Small Cell Lung Cancer Employing Three-Dimensional In Vitro Models. Cells. 2021 Jan 12;10(1):141. doi: 10.3390/cells10010141.
PubMed 33445709Seet-Lee C, Yee J, Morahan H, Ross LS, Edwards KM. The effect of aerobic exercise on tumour blood delivery: a systematic review and meta-analysis. Support Care Cancer. 2022 Nov;30(11):8637-8653. doi: 10.1007/s00520-022-07132-0. Epub 2022 Jun 2.
PubMed 35650456Sasso JP, Eves ND, Christensen JF, Koelwyn GJ, Scott J, Jones LW. A framework for prescription in exercise-oncology research. J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):115-24. doi: 10.1002/jcsm.12042. Epub 2015 May 11.
PubMed 26136187World Health Organization (2023) Lung Cancer
World Health Organization (2018) More active people for a healthier world
Williams, N. (2017) 'The Borg Rating of Perceived Exertion (RPE) scale ', Occupational Medicine, 67 (5), pp. 404-405.
Vinod SK, Hau E. Radiotherapy treatment for lung cancer: Current status and future directions. Respirology. 2020 Nov;25 Suppl 2:61-71. doi: 10.1111/resp.13870. Epub 2020 Jun 9.
PubMed 32516852Viamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558.
PubMed 37819656United Kingdom Lung Cancer Coalition (2024) Driving Quality Improvements in UK Lung Cancer: Utilising good practice and innovation to deliver optimal care and outcomes
Varkey B. Principles of Clinical Ethics and Their Application to Practice. Med Princ Pract. 2021;30(1):17-28. doi: 10.1159/000509119. Epub 2020 Jun 4.
PubMed 32498071Tran DL, Kamaladasa Y, Munoz PA, Kotchetkova I, D'Souza M, Celermajer DS, Maiorana A, Cordina R. Estimating exercise intensity using heart rate in adolescents and adults with congenital heart disease: Are established methods valid? Int J Cardiol Congenit Heart Dis. 2022 Mar 26;8:100362. doi: 10.1016/j.ijcchd.2022.100362. eCollection 2022 Jun.
PubMed 39712058Totton N, Lin J, Julious S, Chowdhury M, Brand A. A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020. Pilot Feasibility Stud. 2023 Nov 21;9(1):188. doi: 10.1186/s40814-023-01416-w.
PubMed 37990337Toohey K, Mizrahi D, Hart NH, Singh B, Lopez P, Hunter M, Newton RU, Schmitz KH, Adams D, Edbrooke L, Hayes S. Exercise in cancer care for people with lung cancer: A narrative synthesis. J Sci Med Sport. 2025 Jan;28(1):16-25. doi: 10.1016/j.jsams.2024.08.002. Epub 2024 Aug 8.
PubMed 39155211Tivey A, Ullah M, Beech A, Ng C, Cove-Smith L. Can frailty screening tools predict completion of chemotherapy and chemotherapy toxicity in patients with thoracic malignancy? J Geriatr Oncol. 2020 Sep;11(7):1154-1156. doi: 10.1016/j.jgo.2020.03.002. Epub 2020 Mar 11. No abstract available.
PubMed 32171694Suveg K, Plasswilm L, Iseli T, Leskow P, Fischer GF, Putora PM. Role of Adjuvant Radiotherapy in Non-Small Cell Lung Cancer-A Review. Cancers (Basel). 2022 Mar 23;14(7):1617. doi: 10.3390/cancers14071617.
PubMed 35406388
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Co-designed PRe-radiotherapy Exercise Programme for People With Stage I-III Non-small Cell Lung cAnCEr: A Single-centre, Single Arm Pilot Study
- ClinicalTrials.gov ID
- NCT07554677
- Acronym / sponsor ID
- PReFACe / 350051
- Conditions
- Lung Cancer
- Keywords
- Radiotherapy, Clinical Trial, Exercise, Physical Activity, feasibility, co-design
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 14 Jan 2027 (estimated)
- Study completion
- 14 Jan 2027 (estimated)
- First posted
- 28 Apr 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.
The goal of this clinical trial is to understand the feasibility of a co-designed, pre-radiotherapy exercise programme for people with stage I-III non-small cell lung cancer. This involves people with lung cancer engaging in 20 minutes exercises sessions performed within the radiotherapy department and immediately before each treatment at a personalised intensity.
The main questions it aims to answer are:
To understand the acceptability of the exercise programme through monitoring recruitment rates, attendance of the exercise sessions, and adherence to prescribed exercise intensities. Adverse events will also be monitored to understand programme safety.
Follow-up qualitative interviews will be conducted with participants, their family members, and health care professionals (HCP) to further explore the acceptability of the exercise programme.
In total, participants will be invited to perform up to twenty, supervised exercise sessions scheduled immediately before each treatment within the radiotherapy department. Each exercise session will be twenty minutes in duration and will be performed on a stationary exercise bike. Regarding exercise intensity, there are four levels which may be prescribed depending on people's exercise history, baseline exercise experience, and personal preference. Participants may progress or regress exercise intensity levels throughout the programme depending on their adherence and preference.
Detailed description
This is a sequential, mixed method feasibility study consisting of two phases:
Phase 1: Quantitative data collection (feasibility outcomes)
Phase 2: Qualitative data collection (semi-structured interviews)
The exercise programme used in this study was co-designed through a series of workshops and meetings involving individuals affected by lung cancer and healthcare professionals.
Eligible participants must be receiving a prescribed radiotherapy dose of either 55 Gy delivered in twenty fractions or 66Gy administered in 15 fractions, adminstered daily over a 3-4 week period. Accordingly, participants will be prescribed either 15 or 20 exercise sessions, performed once daily and scheduled in alignment with their radiotherapy treatment.
Exercise intensity is personalised and based on a submaximal exercise test conducted at the participant's baseline assessment. This test will be used to determine each participant's maximum heart rate, which will then be entered into the Karvonen formula (Karvonen et al., 1957) to calculate percentage heart rate reserve. This calculation will establish individual heart-rate ranges corresponding to light, moderate, and vigorous exercise intensities. Starting exercise intensity level (1-4) will be determined based on a baseline six-minute walking test, clinical frailty score, and participant preference.
The four levels of exercise intensity increase in difficulty, and incorporate various durations of light, moderate, or high intensity exercise, including:
- Level 1: 10-minute warm-up at light intensity continuous cycling followed by 10 minutes of moderate intensity continuous cycling
- Level 2: 5-minute warm-up at light intensity continuous cycling followed by 15 minutes of moderate intensity continuous cycling
- Level 3: 5-minute warm-up at light intensity continuous cycling, followed by 10 minutes of moderate intensity continuous cycling, and 5 minutes of 30-second-high intensity intervals
- Level 4: 5-minute warm-up at light intensity continuous cycling, followed by 5 minutes of 30-second-high intensity intervals, 5 minutes of moderate intensity continuous cycling, and 5 minutes of 30-second-high intensity intervals
All participants will wear a chest-strap heart-rate monitor during each exercise session to ensure they are exercising at the prescribed intensity. Session adherence will be defined as completion of at least 75% of the prescribed exercise duration (i.e. 15-minutes).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Radiotherapy exercise arm | Experimental | Other: Exercise, Radiation: radiotherapyParticipants within the experimental arm will participate in the co-designed, pre-radiotherapy exercise programme alongside treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with clinically or histologically confirmed NSCLC stages 1-3.
- Planned to receive treatment with curative intention radiation as primary treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- At least 18 years of age.
- Can understand and communicate in English.
Key exclusion criteria (17 listed)
- Unstable or new angina (diagnosed within the previous month).
- Unstable or acute heart failure, cardiomyopathy, or other uncontrolled cardiac disease (as evidenced by symptomatic fluid retention, excessive breathlessness, rapid weight gain, swollen ankles or pitting oedema) within the previous 3 months.
- Presence of new or uncontrolled cardiac arrhythmias.
- Confirmed or suspected spinal cord compression.
- Uncontrolled diabetes (e.g. medication changed within 1 month, has had episodes of hypoglycaemia during the previous 2 weeks, or hyperglycaemia which does not decrease with exercise during the previous 2 weeks).
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 |
|---|---|---|
| ExerciseParticipants will participate in up to twenty, supervised exercise sessions, performed within the radiotherapy department, immediately before each treatment. Each session has a 20 minute duration at one of four exercise intensity levels based on the participants baseline assessment results, and preferences. | Other | Pre-Radiotherapy exercise arm |
| radiotherapyStudy participants will have been diagnosed with stage I-III NSCLC and prescribed radiotherapy administered as 55Gy in 20 fractions over 4 weeks or 60Gy in 15 fractions over 3 weeks as their primary treatment as per standard treatment pathways within the trust | Radiation | Pre-Radiotherapy exercise arm |
Primary outcome
Eligibility rates
Time frame: Screening and enrolment
The percentage of eligible participants identified and approached through participant screening
Recruitment rate
Time frame: Screening and recruitment
The total number of potential participants who were approached and agreed to participate as a percentage of the total number who were approached
Exercise programme attendance
Time frame: Weeks 4-8 (PReFACe exercise programme)
The total number of attended sessions by the total number provided
Adherence to the exercise programme
Time frame: Weeks 4-8 (PReFACe exercise programme)
Monitoring the participants ability to complete the advised duration and intensity of exercise during each session (adherence is accepted if completed 75% of duration without intensity modification)
Participant retention rates
Time frame: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)
The number of participants available to provide outcomes at the post-intervention assessment as a percentage of the total number recruited.
Adverse event Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)
Assess the tolerability and safety of the intervention, via recording of intervention-associated adverse events (AE). AEs will be graded according to CTCAE v.5 as: * Grade 1 = Mild * Grade 2 = Moderate * Grade 3 = Severe * Grade 4 = Life-threatening consequences * Grade 5 = Death related to AE
12 secondary outcomes
Change from baseline in quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-items (EORTC QLQ-30)
Time frame: Week 0 (baseline assessment) to week 8 (end of study assessment)
Change from baseline in quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)
Time frame: Week 0 (baseline assessment) to week 8 (end of study assessment)
Impact of exercise programmes effect on symptom burden: Pain likert Scale
Time frame: Week 0 (baseline assessment) to week 8 (end of study assessment)
Impact of exercise programmes effect on symptom burden: Fatigue likert Scale
Time frame: Week 0 (baseline assessment) to week 8 (end of study assessment)
Impact of exercise programmes effect on symptom burden: Modified Medical Research Council (MRC) dyspnoea scale
Time frame: Week 0 (baseline assessment), daily through PReFACe exercise programme (weeks 4-8) and end of study assessment (week 8)
To assess the accessibility, acceptability and experience of the exercise programme through semi-structured qualitative interviews
Time frame: Weeks 8-14 post-intervention follow-up period
Baseline compared to post-intervention changes in participant distress levels using the National Comprehensive Cancer Network (NCCN) Distress thermometer.
Time frame: Baseline assessment (week 0), weekly throughout the PReFACe exercise programme (weeks 4-8) and at post-study assessment (week 8)
Change in baseline to post-intervention physical fitness: Six- minute walking test
Time frame: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical fitness: 30-second sit-to-stand
Time frame: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical functioning: Rockwood Clinical Frailty Scale (CFS)
Time frame: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical activity: The International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: Baseline assessment (week 0) and post-study assessment (week 8)
Change in baseline to post-intervention physical activity: Huffman Exercise Satisfactions Scale
Time frame: Baseline assessment (week 0) and post-study assessment (week 8)
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 30 Oct 2026.
- Background: PubMed 33445709Ziolkowska-Suchanek I. Mimicking Tumor Hypoxia in Non-Small Cell Lung Cancer Employing Three-Dimensional In Vitro Models. Cells. 2021 Jan 12;10(1):141. doi: 10.3390/cells10010141.
- Background: PubMed 35650456Seet-Lee C, Yee J, Morahan H, Ross LS, Edwards KM. The effect of aerobic exercise on tumour blood delivery: a systematic review and meta-analysis. Support Care Cancer. 2022 Nov;30(11):8637-8653. doi: 10.1007/s00520-022-07132-0. Epub 2022 Jun 2.
- Background: PubMed 26136187Sasso JP, Eves ND, Christensen JF, Koelwyn GJ, Scott J, Jones LW. A framework for prescription in exercise-oncology research. J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):115-24. doi: 10.1002/jcsm.12042. Epub 2015 May 11.
- BackgroundWorld Health Organization (2023) Lung Cancer
- BackgroundWorld Health Organization (2018) More active people for a healthier world
- BackgroundWilliams, N. (2017) 'The Borg Rating of Perceived Exertion (RPE) scale ', Occupational Medicine, 67 (5), pp. 404-405.
- Background: PubMed 32516852Vinod SK, Hau E. Radiotherapy treatment for lung cancer: Current status and future directions. Respirology. 2020 Nov;25 Suppl 2:61-71. doi: 10.1111/resp.13870. Epub 2020 Jun 9.
- Background: PubMed 37819656Viamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558.
- BackgroundUnited Kingdom Lung Cancer Coalition (2024) Driving Quality Improvements in UK Lung Cancer: Utilising good practice and innovation to deliver optimal care and outcomes
- Background: PubMed 32498071Varkey B. Principles of Clinical Ethics and Their Application to Practice. Med Princ Pract. 2021;30(1):17-28. doi: 10.1159/000509119. Epub 2020 Jun 4.
- Background: PubMed 39712058Tran DL, Kamaladasa Y, Munoz PA, Kotchetkova I, D'Souza M, Celermajer DS, Maiorana A, Cordina R. Estimating exercise intensity using heart rate in adolescents and adults with congenital heart disease: Are established methods valid? Int J Cardiol Congenit Heart Dis. 2022 Mar 26;8:100362. doi: 10.1016/j.ijcchd.2022.100362. eCollection 2022 Jun.
- Background: PubMed 37990337Totton N, Lin J, Julious S, Chowdhury M, Brand A. A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020. Pilot Feasibility Stud. 2023 Nov 21;9(1):188. doi: 10.1186/s40814-023-01416-w.
- Individual participant dataSharing planned: Undecided. Currently under review with supervisory team
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and radiotherapy in people with Lung Cancer, run by Queen's University, Belfast at 1 site in United Kingdom.
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 7 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Matthew Peter Beggs, MSc, BSc (+44 7759264875., mbeggs06@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rates (time frame: Screening and enrolment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07554677, which also lists 69 linked publications.
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 30 Oct 2026.