Clinical Trial

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

Study acronym: PReFACe
Recruiting
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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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-05
critical Primary endpoint(s) modified 2026-05-06
Trial Details
NCT Number NCT07554677
Lead Sponsor Queen's University, Belfast
Conditions Lung Cancer
Enrollment 30 participants
Start Date 2026-06-10
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-04