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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000256875
Acronym
IMPACTS trial
Enrollment
13
Registered
2021-03-10
Start date
2019-10-01
Completion date
2021-12-31
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine whether a personalised exercise program has any protective effects on the gut microbiota in breast cancer survivors, which may have follow-on effects for overall health and immune response in these patients. Who is it for? You may be eligible for this study if you are aged between 18-80, you are a Stage I-III breast cancer survivor who is 3-12 months post completion of your adjuvant treatment (hormone therapy and Herceptin may be continuing), you have undergone curative surgery and/or chemotherapy and/or radiotherapy and you are currently completing less than the recommended physical activity guidelines (150 minutes of moderate intensity structured activity per week). Study details Participants who enroll in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention or the control treatment. Participants allocated to the intervention treatment will be prescribed an individualised exercise program to be completed for 12 weeks. The exercise program will involve a combination of aerobic exercise (such as jogging/swimming/cycling) and upper and lower limb resistance exercises using a thera-band. Each week, participants in the intervention group will also receive a 10–20-minute telephone call with a member of the research team to discuss their progress and any concerns they may have about the exercise program. Participants allocated to the control treatment will be asked to maintain their current physical activity levels throughout the 12-week intervention. 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. All participants in this study will undergo a baseline (pre-intervention) and follow-up assessment to determine their fitness levels, and will be asked to provide stool and blood samples to determine their levels of inflammation and the characteristics of their gut microbiome. All participants will be asked to wear an activity tracker to monitor their physical activity daily for the 12 weeks of the study. It is hoped this research will demonstrate that moderate physical exercise has a positive effect on the gut microbiota of cancer survivors and this may also reduce systemic inflammation in these patients.

Interventions

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 rand

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.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Stage I-III breast cancer survivors who are 3-12 months post completion of their adjuvant treatment (hormone therapy and Herceptin may be continuing); Undergone curative surgery and/or chemotherapy and/or radiotherapy; Currently completing less than the recommended physical activity guidelines.

Exclusion criteria

Metastatic disease; physical injuries which may preclude them from exercise; unmanaged cardiovascular or metabolic disease; inability to understand the participant information sheet and consent form or to give informed consent. Currently on anti-inflammatory medications that they cannot cease for the duration of the study; current or previous antibiotic use (in the past 3-months).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026