None listed
Conditions
Brief summary
This study aims to explore the impact of home-based exercise sessions supervised via telehealth on the health and fitness of people with breast cancer. Who is it for? You may be eligible for this study if you are an adult aged 18 or over who has been diagnosed with breast cancer, have recently completed anti-cancer therapy, and have a risk of heart damage. Study details All participants will undertake remotely-monitored aerobic exercise sessions at home (e.g., walking, cycling), 3 times per week over 8 weeks. The session length and exercise intensity will be individualised for each participant. Participants will also be provided with general exercise education, and learn about behaviour change through the study mobile application. Participants will be asked to attend three study appointments to complete a questionnaire and undertake a cardiopulmonary exercise test. Each visit with take approximately 75 minutes (15 minutes for the questionnaire and 60 minutes for the exercise test). The visits occur before the study, after 2 months, and after 5 months. It is hoped that this research will help determine if home-based exercise supervised via telehealth in real time is safe and effective in improving the health and fitness of breast cancer patients.
Interventions
The Remote-COR-B Intervention is an exercise intervention delivered using REMOTE technologies. Participants can take part anywhere they can access the internet.
The REMOTE- COR-B platform is comprised of a smartphone and wearable sensor (currently compatible with BioHarness 3, Zephyr Technology and the Polar10), and custom-built smartphone and web apps. The platform facilitates remotely supervised aerobic exercise prescription that is delivered, monitored and coached in real-time by a clinical
The Remote-COR-B Intervention is an exercise intervention delivered using REMOTE technologies. Participants can take part anywhere they can access the internet. The REMOTE- COR-B platform is comprised of a smartphone and wearable sensor (currently compatible with BioHarness 3, Zephyr Technology and the Polar10), and custom-built smartphone and web apps. The platform facilitates remotely supervised aerobic exercise prescription that is delivered, monitored and coached in real-time by a clinical exercise specialist. The exercise specialists delivering the intervention will be qualified exercise professionals (either accredited exercise physiologists or physiotherapists) with experience and/or training in exercise prescription for cancer patients. All exercise specialists will be given an exercise prescription protocol to follow that will be updated as needed based on weekly check ins with trial staff. Exercise prescription: Participants will be asked to participate in three remotely monitored aerobic exercise (e.g., walking, cycling) sessions per week for eight weeks with the aim of increasing cardiorespiratory fitness. The length of the session and exercise intensity will be individually tailored based on rate of perceived exertion (RPE, scale 0-10), objectively measured heart rate, medical history and symptoms reported prior to or during the exercise session. Type: Walking is the preferred aerobic exercise mode but participants can choose other land-based exercise modes if preferred (e.g., cycling, jogging, rowing). Frequency: There will be three remotely monitored sessions per week for eight weeks. Duration: A minimum of 20 minutes each session will be completed where possible. The goal duration is 30-60 minutes. Intensity: Exercise of at least a moderate intensity if advised. Progression: The exercise principle of progressive overload will be used to facilitate continual improvement. It is recognised that in this setting maintenance of exercise dosage may reflect progression for some (e.g., those experiencing fluctuating, but persistent treatment-related side effects) and that small increments in intensity, load, duration and/or frequency will be used to generate overload as appropriate. Participants will exercise with their smartphone (GPS enabled) and while wearing a heart rate sensor. The exercise specialist will monitor participants location, heart rate, RPE, and symptoms via a web-based platform, allowing them to provide individualised audio coaching, feedback and social support throughout the monitoring session, which is delivered to participants via earphones to optimise usability. Outside of real-time interaction, participants receive 1-2 automatically generated push notifications per week containing general exercise education and behaviour change tips (1-4 sentences long). Topics include benefits of exercise for heart health, added benefits of incorporating flexibility and resistance-training exercises into weekly routines, strategies to overcome exercise barriers, increase exercise confidence, exercise enjoyment and develop long lasting exercise habits. Participants can also review all recorded exercise performance data and set weekly intensity or duration goals (based on heart rate data) if they choose to. This is designed to be a brief task and is optional. Participants will be considered adherent to the intervention if they complete at least 17 out of the 24 remotely-monitored exercise sessions (i.e., = 70%). This data is captured automatically by the intervention application.
Sponsors
University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet the following criteria to be included: • Diagnosed with stage I-III breast cancer • Be at risk of cardiotoxicity according to pre-determine criteria (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account e.g., age, obesity, comorbidity) • Have completed primary definitive anticancer therapy within the last 6 months (which may be surgery, radiotherapy or chemotherapy depending on if receiving adjuvant or neo-adjuvant treatment) • Currently completing less than the REMOTE-COR-B target (target: greater than or equal to 150 minutes of moderate-vigorous intensity aerobic activity per week over 3 sessions or more per week; moderate-vigorous intensity exercise is defined as a score of 13 or above on the Borg Rating of Perceived Exertion (RPE) scale). • Eastern Cooperative Oncology Group (ECOG) performance status of 0 (Fully active, able to carry out pre-disease performance without restriction) – 2(Ambulatory and capable of selfcare but unable to carry out any work activities; up and about more than 50% of waking hours). • Proficiency with the English language (Able to read and write in English to the extent they can read the information sheet, understand study directions and can meaningfully engage in the intervention).
Exclusion criteria
Participants will be excluded if they meet any of the following criteria: • Diagnosed with metastatic breast cancer (Stage 4) • Diagnosed with Recurrent Breast Cancer • Have a medical condition where exercise or cardiopulmonary exercise testing is contraindicated • Are unable to provide informed consent • Are unable to fully participate in study assessments • Have an implanted cardiac device • Are participating in another exercise study or exercise program with similar goals • Are participating in a clinical trial that presents safety or contamination issues for either trial
Outcome results
None listed