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

NCT06595147 | Recruiting

• 1 other identifier: HREBA.CC-24-0058
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability Physical; Heart Failure; Cardiotoxicity; Breast Cancer

Keywords

Exercise Training; Fitness; Heart; Muscle; Cancer; Survivorship

Outcome Measures

Primary Outcomes (2)

• Peak arterio-venous oxygen content difference

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

  12 Weeks

• Peak cardiac output

  Peak exercise cardiac output assessed using whole-body exercise MRI

  12 Weeks

Secondary Outcomes (13)

• Peak volume of oxygen uptake

  12 Weeks

• Peak diffusive muscle oxygen conductance

  12 Weeks

• Peak stroke volume

  12 Weeks

• Aerobic endurance

  12 Weeks

• Physical Function

  12 Weeks

Other Outcomes (7)

• Habitual Physical Activity

  12 Weeks

• Fasting Lipids

  12 Weeks

• Fasting Glycaemic Control

  12 Weeks

Study Arms (2)

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.

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

Behavioral: Group-based Yoga and Stretching

Interventions

Structured Exercise Training BEHAVIORAL

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

Experimental Arm: Structured Exercise Training

Group-based Yoga and Stretching BEHAVIORAL

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

Active Comparator: Group-based Yoga and Stretching

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G1C9, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Heart Failure; Cardiotoxicity; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Nathan Weeldreyer, PhD

CONTACT

616.566.6756; ageheart@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All MRI outcomes will be performed blinded to group allocation. Outcome assessors for post-outcome assessments will be blinded to baseline values.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)