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

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:

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.

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 55 Gy delivered in twenty fractions only, administered once daily, five days per week, over a four-week period. Accordingly, participants will be prescribed a total of twenty exercise sessions, performed once daily and scheduled in alignment with their radiotherapy treatment sessions.

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).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

  • 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.