Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured Exercise Training, Group-based Yoga and Stretching.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Disability Physical, Heart Failure, Cardiotoxicity. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Structured Exercise Training
Participants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week. - Behavioral Group-based Yoga and Stretching
Participants will complete 12-weeks of supervised group-based yoga and stretching once per week.
Primary outcome measures
- Peak arterio-venous oxygen content difference [Time frame: 12 Weeks]
- Peak cardiac output [Time frame: 12 Weeks]
Secondary outcome measures (12)
- Peak volume of oxygen uptake [Time frame: 12 Weeks]
- Peak diffusive muscle oxygen conductance [Time frame: 12 Weeks]
- Peak stroke volume [Time frame: 12 Weeks]
- Aerobic endurance [Time frame: 12 Weeks]
- Physical Function [Time frame: 12 Weeks]
- Skeletal muscle volume [Time frame: 12 Weeks]
- Skeletal muscle myosteatosis [Time frame: 12 Weeks]
- Skeletal muscle fibrosis [Time frame: 12 Weeks]
- Calf muscle aerobic capacity [Time frame: 12 Weeks]
- Calf muscle oxygen extraction [Time frame: 12 Weeks]
- Calf muscle oxygen diffusive conductance [Time frame: 12 Weeks]
- Calf muscle metabolism [Time frame: 12 Weeks]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT06595147 · HREBA.CC-24-0058