ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001001785

Ethics application status

Approved

Date submitted

8/07/2022

Date registered

15/07/2022

Date last updated

15/07/2022

Date data sharing statement initially provided

15/07/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Physical Activity and Lung cancer Screening (PALS): a feasibility randomised controlled trial of exercise and physical activity in lung cancer screening.

Scientific title

Physical Activity and Lung cancer Screening (PALS): a feasibility randomised controlled trial of exercise and physical activity in lung cancer screening.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

This is a substudy of the International Lung Screen Trial NCT02871856.

Health condition

Health condition(s) or problem(s) studied:

lung cancer screening

Condition category

Condition code

Cancer

Lung - Non small cell

Cancer

Lung - Small cell

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Lifestyle

Intervention code [2]

Prevention

Comparator / control treatment

1. Usual care: No intervention, Participant will continue with pre-existing medical, nursing and allied health care.
2. Written material: Australia’s physical activity and sedentary behavior guidelines by the Department of Health will be provided to participants in person at the time of their enrollment. Use of the written material will be assessed at the 9 week assessment.

Comparison arms will run 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.

Control group

Active

Outcomes

Primary outcome [1]

1. Feasibility, assessed by proportion of home-based exercise sessions completed and recorded during weekly review sessions, of an 8-week multi-modal exercise program targeted at improving health related quality of life and physical activity levels of participants of lung cancer screening.

Timepoint [1]

At 9 weeks from enrollment, following intervention completion.

Primary outcome [2]

2. Safety of an 8-week multi-modal exercise program targeted at improving health related quality of life and physical activity levels of participants of lung cancer screening. Safety will be assessed by the number of adverse events occurring during or within 60 minutes following the intervention. Serious adverse events are defined as any adverse event related to the study that resulted in death or is life threatening, requiring hospitalisation, causing disability or incapacity. Minor adverse events were those that are directly caused by exercise such as: a minor fall (not resulting in a serious adverse event), new or progressive pain, transient neurological deficits, transient altered mental status, palpitations or progressive fatigue. Adverse events will be recorded by participant self reporting in accordance with Common Terminology Criteria for Adverse Events (CTCAE5.0).

Timepoint [2]

At each weekly review during the intervention and at 9 weeks from enrollment, following intervention completion.

Primary outcome [3]

Feasibility, assessed by the proportion of participants enrolled in the study when offered, of an 8-week multi-modal exercise program targeted at improving health related quality of life and physical activity levels of participants of lung cancer screening.

Timepoint [3]

At 9 weeks from enrollment, following intervention completion.

Secondary outcome [1]

Physical activity levels assessed by International Physical Activity Questionnaire.

Timepoint [1]