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Trial registered on ANZCTR

Registration number

ACTRN12621000256875

Ethics application status

Approved

Date submitted

14/01/2021

Date registered

10/03/2021

Date last updated

10/03/2021

Date data sharing statement initially provided

10/03/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Inflammation and the Microbiome: the effect of Physical Activity in cancer Survivors (IMPACT Trial)

Scientific title

Inflammation and the Microbiome: the effect of Physical ACTivity in breast cancer Survivors (IMPACTS Trial)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1262-1094

Trial acronym

IMPACTS trial

Linked study record

Health condition

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

Cancer

Inflammation

Condition category

Condition code

Cancer

Breast

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Inflammation and the microbiome: The effect of Physical Activity. This Randomised controlled trial is designed to investigate the effect of individualised, home based physical activity on the composition and function of the gut microbiome and systemic inflammation in cancer survivors. After informed consent is obtained, participants undergo baseline testing. Both tester and participant are blinded to the assigned intervention arm at baseline testing. After baseline testing, participants are randomised into either the exercise arm or the control arm.
Exercise arm:
Participants randomised to the exercise arm undergo a 12-week, home based individualised exercise program which adheres to the recommended physical activity guidelines from the American College of Sports Medicine (ACSM) which are echoed by Exercise and Sports Science Australia (ESSA) and the Clinical Oncology Society of Australia (COSA). This includes 150 minutes of moderate intensity aerobic physical activity (brisk walk, jog, cycle, swim) and 2-3 moderate intensity resistance exercise sessions per week. Participants in this study are given resistance bands of three different intensities to use at home to complete resistance exercises and prescribed resistance band and body weight exercises. After baseline testing an individual exercise program is devised by an accredited exercise physiologist with over 5 years’ experience in working with cancer cohorts. Whilst individualised, the program will consist of aerobic capacity exercise and resistance exercises including a mix of upper and lower body exercises. Participants will be educated on the use of the Rating of Perceived Exertion (RPE) scale to assess and monitor intensity of exercise. Participants will be given an activity diary to record their weekly physical activity including duration and intensity of aerobic capacity activity, step count and frequency of resistance exercises as well as load (which thera-band used), sets, repetitions and perceived intensity (RPE). There is no minimum duration for resistance exercise sessions, but participants will be prescribed a minimum of 6 exercises and a maximum of 8 exercises to complete per session. Weekly telephone support will be provided to participants in the exercise arm by researchers which will include a discussion around adherence and compliance to the exercise program, as well as discussion of any barriers faced by the participants. It is anticipated that the duration of these weekly phone calls will be 10-20 minutes in duration. This weekly telephone support will also be used to discuss intensity of the exercises and to plan and encourage exercise progression where appropriate.
Exercise progression:
Participants will be asked to use the modified RPE scale (1-10; 1= no exertion at all; 10 maximal exertion). They will be asked to rate the exercise at completion. The target RPE will be 4-6 indicating a moderate to hard intensity. Participants will be guided on the use of this scale at the initial testing session and educated on how to progress based on the scale. Once the exercise is rated 3-4 the participant will be encouraged to increase the reps/ sets or load as appropriate. Exercises will start at 2-3 sets of 8-10 reps and be progressed to 4 sets of 12 reps before increasing the load. Importantly, participants will be asked to perform exercises at approximately 4-6 RPE and progress the exercises when the perceived exertion falls below this rating.

Intervention code [1]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

Control arm:
Participants randomised to the control arm after baseline testing are asked to maintain their current physical activity levels throughout the 12-week intervention. They will also be given an activity tracker to wear throughout the intervention to record physical activity levels. No telephone support will be provided to the control participants throughout the intervention. At the completion of the intervention, after follow-up testing, the control participants will be offered an opportunity to receive an individualised exercise program.

Control group

Active

Outcomes

Primary outcome [1]

Fecal Microbiota profile assessed through 16s rRNA gene sequencing of fecal samples.

Timepoint [1]