About this trial
This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:
* What is the impact of exercise on cardiometabolic health and body composition in BC survivors? * What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition? * Is there a link between the capacity of skeletal muscle adaptation to exercise (and diet) and insulin resistance in BC survivors?
The investigators hypothesize that: 1) exercise will improve cardiometabolic and body composition outcomes 2) improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality, which will be essential or additive for Matsuda index, metabolic syndrome, Framingham CVD risk, thigh myosteatosis, muscle mass, VO2peak, 3) skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins (e.g. GLUT4) and co-occur with impaired muscle quality (e.g., higher rates of fat depots, presence of fibrous tissue) negatively impacting insulin signalling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biologically female
Diagnosis of stage I, II, or III breast cancer, post-menopausal at the time of diagnosis (haven't had a menstrual cycle within 12 months or greater)
Receipt of aromatase inhibitors for 12 months or more in the past, but do not have to be currently on aromatase inhibitors.
Willing and able to complete all study assessments
Disqualifiers
Received chemotherapy within the past 11 months
Diagnosed with metastatic cancer
Currently taking tamoxifen
Currently receiving chemotherapy, targeted therapy or radiation treatment
Trial design
Parallel
Treatments tested in this trial
Guidelines-based healthy eating
BehavioralOne-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.
Guidelines-based physical activity
BehavioralThrough a combination of exercise trainer-led in-person and virtual sessions, as well as counselling for independent aerobic exercise, participants will be guided to achieve 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.
Stretching exercise
BehavioralTwice weekly virtual instructor-led whole-body stretching.
Treatment groups
Trial outcomes
Primary outcomes
Insulin resistance
As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).
Secondary outcomes
Hepatic insulin resistance
Indirectly measured via HOMA-IR using fasting glucose and insulin levels
Metabolic syndrome severity
Calculated as a z-score to allow for tracking change in the interventions
Framingham 10-year risk (%)
Calculated using a widely-used standardized scoring system
Other outcomes
Cardiorespiratory fitness
Measured as peak volume of oxygen consumption via indirect calorimetry during a cardiopulmonary exercise test on a treadmill.
Heart Rate Recovery
Measured as the difference between peak heart rate during the cardiorespiratory fitness test and heart rate 2-minutes after stopping the exercise test.
avO2 difference
Calculated as the VO2 from the corresponding workload from the day 1 treadmill test divided by cardiac output at rest, submaximal, and maximal periods of the treadmill test
Blood Pressure
Measured as the average of the last 5 of 6 blood pressure measurements using an automatic blood pressure device.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator