ClinicalTrials.gg
RecruitingNCT06595147BE-FITTERUpdated Jan 8, 2026

Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study

An interventional study of Structured Exercise Training and Group-based Yoga and Stretching in Breast Cancer, Disability Physical and Heart Failure, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by University of Alberta · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Disability Physical
  • Heart Failure
  • Cardiotoxicity

Keywords

  • Exercise Training
  • Fitness
  • Heart
  • Muscle
  • Cancer
  • Survivorship
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Have a history of coronary artery disease, heart failure, persistent and permanent arrhythmia (e.g. currently in atrial fibrillation), stroke, or
  • Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST segment depression on ) during the cardiopulmonary (VO2peak) test
  • Have any research MRI (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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental Arm: 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.

    Behavioral: Structured Exercise Training

  • Active comparator
    Active Comparator: 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

    Behavioral: Group-based Yoga and Stretching

Interventions

  • BehavioralStructured Exercise Training

    Participants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week.

  • BehavioralGroup-based Yoga and Stretching

    Participants will complete 12-weeks of supervised group-based yoga and stretching once per week.

06

What researchers measure

Primary outcomes

  1. Peak arterio-venous oxygen content difference

    Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI

    Time frame: 12 Weeks

  2. Peak cardiac output

    Peak exercise cardiac output assessed using whole-body exercise MRI

    Time frame: 12 Weeks

Secondary outcomes

  1. Peak volume of oxygen uptake

    Peak volume of oxygen uptake assessed from a maximal cardiopulmonary exercise test

    Time frame: 12 Weeks

  2. Peak diffusive muscle oxygen conductance

    Calculated diffusive muscle oxygen conductance assessed using whole-body exercise MRI

    Time frame: 12 Weeks

  3. Peak stroke volume

    Peak exercise stroke volume assessed using whole-body exercise MRI

    Time frame: 12 Weeks

  4. Aerobic endurance

    Walk distance measured during a six minute walk test

    Time frame: 12 Weeks

  5. Physical Function

    Short physical performance battery total score (Score from 0 to 12, where higher scores represent better function)

    Time frame: 12 Weeks

  6. Skeletal muscle volume

    Muscle volume of the thigh and lower leg from MRI

    Time frame: 12 Weeks

  7. Skeletal muscle myosteatosis

    Muscular fat fraction of the thigh and lower leg from MRI

    Time frame: 12 Weeks

  8. Skeletal muscle fibrosis

    Muscular fibrosis of the thigh and lower leg measured from MRI T1 values

    Time frame: 12 Weeks

  9. Calf muscle aerobic capacity

    Peak muscle oxygen uptake from maximal plantar flexion exercise MRI

    Time frame: 12 Weeks

  10. Calf muscle oxygen extraction

    Peak muscle arterio-venous oxygen difference from maximal plantar flexion exercise MRI

    Time frame: 12 Weeks

  11. Calf muscle oxygen diffusive conductance

    Peak muscle oxygen diffusive conductance from maximal plantar flexion exercise MRI

    Time frame: 12 Weeks

  12. Calf muscle metabolism

    Exercise phosphate and phosphocreatine responses during plantar flexion exercise 31P magnetic resonance spectroscopy

    Time frame: 12 Weeks

  13. 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.

    Time frame: 12 Weeks

Other outcomes

  1. Habitual Physical Activity

    Time spent in moderate-to-vigorous physical activity over 7 days of objective monitoring (Fitbit)

    Time frame: 12 Weeks

  2. 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

    Time frame: 12 Weeks

  3. Fasting Glycaemic Control

    A fasting blood test will be used to measure concentrations of fasting plasma glucose and fasting insulin

    Time frame: 12 Weeks

  4. 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.

    Time frame: 12 Weeks

  5. C-reactive protein

    Plasma concentrations of C-reactive protein will be assessed from a fasting blood test.

    Time frame: 12 Weeks

  6. Resting blood pressure

    Resting systolic and diastolic blood pressure will be measured in the supine position using an automated oscillometric blood pressure cuff.

    Time frame: 12 Weeks

  7. Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire

    Quality of Life, including physical, emotional and social wellbeing and breast cancer related symptom score on the FACT-B questionnaire. Participants will be scored from 0 to 148, where 148 represents the highest quality of life.

    Time frame: 12 Weeks

07

Study locations

1 of 1 sites recruiting
  • University of Alberta
    Edmonton, Alberta T6G1C9, Canada
    Recruiting
    • Nathan Weeldreyer, PhD · Contactageheart@ualberta.ca · 616.566.6756
    • Mark Haykowsky, PhD · Principal investigator
    • Edith Pituskin, PhD · Sub investigator
    • Richard B Thompson, PhD · Sub investigator
    • Margaret McNeely, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06595147
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Jul 1, 2024
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Jan 8, 2026

Study contacts

Nathan Weeldreyer, PhD
Contact
ageheart@ualberta.ca
616.566.6756

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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