Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study

NCT07554677 | Not Yet Recruiting

• 2 other identifiers: 35005125017GP-SS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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 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.

Conditions

Lung Cancer

Keywords

Radiotherapy; Clinical Trial; Exercise; Physical Activity; feasibility; co-design

Outcome Measures

Primary Outcomes (6)

• Eligibility rates

  The percentage of eligible participants identified and approached through participant screening

  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

  Screening and recruitment

• Exercise programme attendance

  The total number of attended sessions by the total number provided

  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)

  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.

  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

  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)

  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)

  Week 0 (baseline assessment) to week 8 (end of study assessment)

• Impact of exercise programmes effect on symptom burden: Pain likert Scale

  Week 0 (baseline assessment) to week 8 (end of study assessment)

• Impact of exercise programmes effect on symptom burden: Fatigue likert Scale

  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

  Week 0 (baseline assessment), daily through PReFACe exercise programme (weeks 4-8) and end of study assessment (week 8)

Study Arms (1)

Pre-Radiotherapy exercise arm

EXPERIMENTAL

Participants within the experimental arm will participate in the co-designed, pre-radiotherapy exercise programme alongside treatment.

Other: Exercise; Radiation: radiotherapy

Interventions

Exercise OTHER

Participants will participate in twenty, supervised exercise sessions, performed within the radiotherapy department, immediately before treatment. Each session has a 20 minute duration at one of four exercise intensity levels based on the participants baseline assessment results, and preferences.

Pre-Radiotherapy exercise arm

radiotherapy RADIATION

Participants involved in this study will receive 55 Gray (Gy) of radiotherapy only, administered in twenty fractions as per standard treatment pathways within the trust

Pre-Radiotherapy exercise arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Northern Ireland Cancer Centre, City Hospital, BHSCT

Belfast, Antrim, BT9 7JL, United Kingdom

Location

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MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Exercise; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics

Central Study Contacts

Matthew Peter Beggs, MSc, BSc

CONTACT

+44 7759264875.; mbeggs06@qub.ac.uk

Gillian Dr Prue, PhD., HCPC, FHEA, MCSP

CONTACT

+44 28 9097 2345; g.prue@qub.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Gillian Prue PhD., HCPC registered, FHEA, MCSP

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

GB (1)