About this trial
The chemotherapy medications used for breast cancer treatment are important for achieving a cure, but a potential side effect is that they can cause a decline in functional capacity (reduced exercise tolerance and impaired physical function) and increase the risk of cardiovascular disease. The risks of decreased functional capacity and cardiovascular disease are highest in breast cancer survivors as they grow older. The factors causing the decline in functional capacity are not well understood, however they may be related to a reduction in cardiac function (e.g. decreased pumping ability of the heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise training is used for other populations at risk for cardiovascular disease (such as cardiac rehabilitation), but is not routinely offered to breast cancer survivors. Therefore this research study wants to test whether exercise training can improve heart and muscle health, and increase functional capacity in up to 60 older breast cancer survivors aged \>60 years old who previously received chemotherapy drugs that can affect the heart.
The purpose of this study is to compare two rehabilitation approaches: a 12-week structured exercise training program or a 12-week stretching-yoga program. The investigators want to compare whether these programs can improve functional capacity, and heart and skeletal muscle function. To do this, some of the participants in this study will be randomly enrolled in the structured exercise training program and others will be randomly enrolled in the stretching-yoga program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥60 years
Previously diagnosed with early-stage (I-III) BC
Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-based chemotherapy or trastuzumab-based biological therapy).
Disqualifiers
Have a history of coronary artery disease, heart failure, persistent and permanent arrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructive pulmonary disease
Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST segment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test
Have any research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing
Currently performing structured exercise training (defined as ≥30 mins/day of moderate-to-vigorous aerobic and/or resistance exercise training on ≥4 days/week)
Trial design
Parallel
Treatments tested in this trial
Structured Exercise Training
BehavioralParticipants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week.
Group-based Yoga and Stretching
BehavioralParticipants will complete 12-weeks of supervised group-based yoga and stretching once per week.
Treatment groups
Trial outcomes
Primary outcomes
Peak arterio-venous oxygen content difference
Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI
Peak cardiac output
Peak exercise cardiac output assessed using whole-body exercise MRI
Secondary outcomes
Peak volume of oxygen uptake
Peak volume of oxygen uptake assessed from a maximal cardiopulmonary exercise test
Peak diffusive muscle oxygen conductance
Calculated diffusive muscle oxygen conductance assessed using whole-body exercise MRI
Peak stroke volume
Peak exercise stroke volume assessed using whole-body exercise MRI
Aerobic endurance
Walk distance measured during a six minute walk test
Other outcomes
Habitual Physical Activity
Time spent in moderate-to-vigorous physical activity over 7 days of objective monitoring (Fitbit)
Fasting Lipids
A fasting blood test will be used to measure concentrations of high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol and triglycerides
Fasting Glycaemic Control
A fasting blood test will be used to measure concentrations of fasting plasma glucose and fasting insulin
Fasting Insulin Resistance
Fasting insulin resistance will be calculated from fasting plasma glucose and insulin concentrations using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) method.
Sponsors and contacts
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University of Alberta
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator