Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
- Conditions
- Breast CancerDisability PhysicalHeart FailureCardiotoxicity
- Interventions
- Behavioral: Structured Exercise TrainingBehavioral: Group-based Yoga and Stretching
- Registration Number
- NCT06595147
- Lead Sponsor
- University of Alberta
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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).
- 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)
- Are unwilling to be randomized to either ExT or STRETCH
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm: Structured Exercise Training Structured Exercise Training Participants randomized to exercise training will be provided with a 12-week structured exercise training program. The program includes 3 weekly sessions of aerobic exercise (e.g treadmill, cycling, elliptical machine) and/or resistance training (i.e lifting weights). The aerobic sessions will include long-endurance (40-60 minutes at moderate intensity), tempo (30-40 minutes at a moderate-vigorous intensity) and high-intensity interval exercise (10-15 intervals of 30-60 seconds at 100% peak aerobic power output, interspersed with 60 seconds of active recovery). Resistance training will include 4-6 lower body exercises performed for 2-3 sets of 8-20 repetitions at a load equivalent to 60-85% of their one repetition maximum. The program will be supervised by an exercise trainer (Clinical Exercise Physiologist, Physiotherapist, Kinesiologist or Research Associate with exercise training experience) and will be individualized each individual's baseline fitness and medical history. Active Comparator: Group-based Yoga and Stretching Group-based Yoga and Stretching Participants allocated to the yoga and stretching group will provided with a once weekly yoga and stretching group class. The classes will consist of a combination of light-intensity yoga, balance and stretching exercises. The yoga and stretching class will be overseen by a yoga instructor, physiotherapist, physiotherapy trainee or research assistant with exercise training background
- Primary Outcome Measures
Name Time Method Peak arterio-venous oxygen content difference 12 Weeks Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI
Peak cardiac output 12 Weeks Peak exercise cardiac output assessed using whole-body exercise MRI
- Secondary Outcome Measures
Name Time Method Peak volume of oxygen uptake 12 Weeks Peak volume of oxygen uptake assessed from a maximal cardiopulmonary exercise test
Peak diffusive muscle oxygen conductance 12 Weeks Calculated diffusive muscle oxygen conductance assessed using whole-body exercise MRI
Peak stroke volume 12 Weeks Peak exercise stroke volume assessed using whole-body exercise MRI
Aerobic endurance 12 Weeks Walk distance measured during a six minute walk test
Physical Function 12 Weeks Short physical performance battery total score (Score from 0 to 12, where higher scores represent better function)
Skeletal muscle volume 12 Weeks Muscle volume of the thigh and lower leg from MRI
Skeletal muscle myosteatosis 12 Weeks Muscular fat fraction of the thigh and lower leg from MRI
Skeletal muscle fibrosis 12 Weeks Muscular fibrosis of the thigh and lower leg measured from MRI T1 values
Calf muscle aerobic capacity 12 Weeks Peak muscle oxygen uptake from maximal plantar flexion exercise MRI
Calf muscle oxygen extraction 12 Weeks Peak muscle arterio-venous oxygen difference from maximal plantar flexion exercise MRI
Calf muscle oxygen diffusive conductance 12 Weeks Peak muscle oxygen diffusive conductance from maximal plantar flexion exercise MRI
Calf muscle metabolism 12 Weeks Exercise phosphate and phosphocreatine responses during plantar flexion exercise 31P magnetic resonance spectroscopy
10-year Framingham Risk Score 12 Weeks 10-year Framingham Risk Score will be calculated from participant Sex, Age, HDL-cholesterol, Total Cholesterol, Resting Systolic Blood Pressure, Smoking Status and presence of Diabetes. The score ranges from 0% to 100% where higher scores indicate higher CVD risk.
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada