Breast CancerBE-FITTERNCT06595147
Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
A study testing Structured Exercise Training and Group-based Yoga and Stretching in people with Breast Cancer and Disability Physical, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer, Disability Physical, Heart Failure
- What is being tested?
- Structured Exercise Training and Group-based Yoga and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2024to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G1C9
Nathan Weeldreyer, PhD, 616.566.6756, ageheart@ualberta.ca
Mark Haykowsky, PhD
About this study
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.
- Conditions
- Breast Cancer, Disability Physical, Heart Failure, Cardiotoxicity
- Being tested
- Structured Exercise Training, Group-based Yoga and Stretching
- Keywords
- Exercise Training, Fitness, Heart, Muscle, Cancer, Survivorship
- Medical subject headings
- Breast Neoplasms, Heart Failure, Cardiotoxicity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise TrainingBehavioural
Participants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week.
Group-based Yoga and StretchingBehavioural
Participants will complete 12-weeks of supervised group-based yoga and stretching once per week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Structured Exercise Training | Experimental | 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. Receives: Behavioral: Structured Exercise Training |
| Active Comparator: Group-based Yoga and Stretching | Active comparator | 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 Receives: Behavioral: Group-based Yoga and Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak arterio-venous oxygen content difference
Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI
Measured: 12 Weeks
Peak cardiac output
Peak exercise cardiac output assessed using whole-body exercise MRI
Measured: 12 Weeks
Secondary outcomes (13)
Peak volume of oxygen uptake
Peak volume of oxygen uptake assessed from a maximal cardiopulmonary exercise test
Measured: 12 Weeks
Peak diffusive muscle oxygen conductance
Calculated diffusive muscle oxygen conductance assessed using whole-body exercise MRI
Measured: 12 Weeks
Peak stroke volume
Peak exercise stroke volume assessed using whole-body exercise MRI
Measured: 12 Weeks
Aerobic endurance
Walk distance measured during a six minute walk test
Measured: 12 Weeks
Physical Function
Short physical performance battery total score (Score from 0 to 12, where higher scores represent better function)
Measured: 12 Weeks
Skeletal muscle volume
Muscle volume of the thigh and lower leg from MRI
Measured: 12 Weeks
Skeletal muscle myosteatosis
Muscular fat fraction of the thigh and lower leg from MRI
Measured: 12 Weeks
Skeletal muscle fibrosis
Muscular fibrosis of the thigh and lower leg measured from MRI T1 values
Measured: 12 Weeks
Calf muscle aerobic capacity
Peak muscle oxygen uptake from maximal plantar flexion exercise MRI
Measured: 12 Weeks
Calf muscle oxygen extraction
Peak muscle arterio-venous oxygen difference from maximal plantar flexion exercise MRI
Measured: 12 Weeks
Calf muscle oxygen diffusive conductance
Peak muscle oxygen diffusive conductance from maximal plantar flexion exercise MRI
Measured: 12 Weeks
Calf muscle metabolism
Exercise phosphate and phosphocreatine responses during plantar flexion exercise 31P magnetic resonance spectroscopy
Measured: 12 Weeks
10-year Framingham Risk Score
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595147
- Sponsor's protocol ID
- HREBA.CC-24-0058
- Acronym
- BE-FITTER
- Status last verified
- Jan 2026
- First submitted
- 6 May 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
- ClinicalTrials.gov ID
- NCT06595147
- Acronym / sponsor ID
- BE-FITTER / HREBA.CC-24-0058
- Conditions
- Breast Cancer, Disability Physical, Heart Failure, Cardiotoxicity
- Keywords
- Exercise Training, Fitness, Heart, Muscle, Cancer, Survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Structured Exercise Training | Experimental | Behavioral: Structured Exercise TrainingParticipants 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 | Active comparator | Behavioral: Group-based Yoga and StretchingParticipants 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Exercise TrainingParticipants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week. | Behavioural | Experimental Arm: Structured Exercise Training |
| Group-based Yoga and StretchingParticipants will complete 12-weeks of supervised group-based yoga and stretching once per week. | Behavioural | Active Comparator: Group-based Yoga and Stretching |
Primary outcome
Peak arterio-venous oxygen content difference
Time frame: 12 Weeks
Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI
Peak cardiac output
Time frame: 12 Weeks
Peak exercise cardiac output assessed using whole-body exercise MRI
13 secondary outcomes
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
10-year Framingham Risk Score
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise Training and Group-based Yoga and Stretching in people with Breast Cancer and Disability Physical, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Weeldreyer, PhD (616.566.6756, ageheart@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak arterio-venous oxygen content difference (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.