None listed
Conditions
Brief summary
Lung cancer is the largest cause of cancer related death in the world. Low dose computed tomography (LDCT) is a scan that reduces deaths from lung cancer by detecting early disease, which is currently being investigated as a screening program for current or former smokers as part of the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital. Physical activity is a potentially modifiable risk factor for the development of lung cancer. Therefore, the purpose of this study is to see if it is feasible to implement an exercise program as part of lung cancer screening to modify an individual’s risk profile. Who is it for? You may be eligible for this study if you are aged 55 to 80 years, are already enrolled in the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital (NCT02871856), and are a current or former smoker estimated to be at a high risk of lung cancer. Study details Participants will be randomised (i.e. allocated by chance) to either the intervention group, which will receive a home-based exercise program, or to a control group that will not receive the exercise program. The home-based exercise program will involve an 8 week unsupervised program consisting of education, aerobic exercise, and resistance training, with weekly progress reviews and goal setting. Weekly progress reviews and goal settings involves a telehealth or telephone consultation of up to 30 minutes per week. Targets for aerobic exercise over the week will range up to 300 minutes per week divided over multiple sessions. Resistance training will be up to two 30 minute sessions per week. Participants allocated to the exercise program will also receive written materials describing Australia’s physical activity and sedentary behaviour guidelines, and will continue to receive usual care, defined as their current medical, nursing and allied health support. Participants in the control group will receive usual care and access to the written materials only. 9 weeks after commencing the intervention or control treatments, all participants will be assessed for feasibility of the intervention by adherence to exercise sessions, as well as for safety of the intervention by number of adverse events occurring during or within 60 minutes following the intervention. Participants will also be assessed for any changes in known contributors to lung cancer risk, including physical activity levels, exercise capacity, muscle strength, body composition, and overall health and wellbeing at 9 weeks and 6 months after commencing the intervention or control treatments. It is hoped that this study may show that the addition of a home-based exercise program to lung cancer screening is feasible, safe, and is able to improve the lung cancer risk profile of current or former smokers.
Interventions
Home based exercise program (in addition to written material and usual care) individualised to the person (their ability and safety to perform the exercises). The program will be conducted remotely medical staff and physiotherapists trained in the intervention protocol. The program will run for 8 weeks and participants will be encouraged to exercise at home unsupervised. The program consists of weekly video-conferencing and/or telephone call support for up to 30 minutes (choice up to participa
Home based exercise program (in addition to written material and usual care) individualised to the person (their ability and safety to perform the exercises). The program will be conducted remotely medical staff and physiotherapists trained in the intervention protocol. The program will run for 8 weeks and participants will be encouraged to exercise at home unsupervised. The program consists of weekly video-conferencing and/or telephone call support for up to 30 minutes (choice up to participant) for 8 weeks. The home program will consist of; a. Initial education session about symptom assessment and self-management including overcoming barriers to exercise will be included as part of the first remote exercise program session via telehealth or telephone. b. Resistance training: comprised of 5 simple functional resistance exercises using gravity or body weight. These will be individualised to the participants ability. There will be a mix of upper body and lower body exercises. Examples include squats, static wall squats, sit-to-stands, calf raises, stair climbing, wall push-ups, shoulder presses and bicep curls. The aim will be to complete each exercise 8-15 times (repetitions) in 2 – 3 sets, depending on the individual participant (this will be assessed during the first session). If the participant has access to exercise equipment at home, such as light hand-held weights (< 5 kg) or theraband, we can utilise this equipment in their program should they wish too. c. Aerobic exercise: comprised of a moderate intensity walking program as defined by a modified Borg score of 3 to 4 for shortness of breath, or targeting a heart rate of 65 to 76% estimated maximum heart rate. d. Weekly progress review and goal setting, aiming to meet the Australian guideline recommendation for 150 to 300 minutes of moderate intensity physical activity (or 75 to 150 minutes of vigorous intensity physical activity) in addition to at least 2 days of muscle strengthening activities. The total number and duration of unsupervised resistance training and aerobic sessions will be determined after discussion with the participant. Demonstration of exercises will be provided either at the time of the assessment via telehealth or via email with provision of written and pictorial demonstrations. Adherence will be monitored by participant self-reporting and attendance checklists. The intervention will be conducted independent to lung cancer screening scans, however baseline assessments will be scheduled at the same time as screening scans if feasible to minimise inconvenience to participant.
Sponsors
Asha Bonney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
People already enrolled in the International Lung Screening Trial (ILST, NCT02871856. ) at the Royal Melbourne Hospital. To be eligible for the program patients must be: - Women or men age 55 to 80 years at the time of recruitment to the ILST. - Current or former smokers. A former smoker is defined as one who has stopped smoking for one or more years. - An estimated 6-year lung cancer risk of greater than or equal to 1.51% based on the PLCOm2012 risk prediction model or greater than or equal to 30 pack-years smoking history (pack-year is defined as number of pack of cigarettes smoked per day multiply by the number of years smoked. If a participant stopped smoking for 6 months or more and then restarted smoking again, the time will be subtracted from the total duration of smoking in 0.5 year increments) - ECOG performance status 0 or 1 Capable of providing, informed consent for screening procedures (low dose spiral CT)
Exclusion criteria
Unable to ambulate 100m independently +/- aid Unable to safety complete the home-based components of the intervention. Co-morbidity or medical status preventing exercise, for example acute uncontrolled cardiovascular or respiratory issues Have a diagnosis of lung cancer
Outcome results
None listed