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

Last updated: September 25, 2024
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Breast Cancer

Hyponatremia

Treatment

Group-based Yoga and Stretching

Structured Exercise Training

Clinical Study ID

NCT06595147
HREBA.CC-24-0058
  • Ages > 60
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥60 years

  • Previously diagnosed with early-stage (I-III) BC

  • Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-basedchemotherapy or trastuzumab-based biological therapy).

Exclusion

Exclusion Criteria:

  • Have a history of coronary artery disease, heart failure, persistent and permanentarrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructivepulmonary disease

  • Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping STsegment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test

  • Have any research MRI contraindications (e.g. any type of pacemaker), or anyorthopedic limitation preventing exercise testing

  • Currently performing structured exercise training (defined as ≥30 mins/day ofmoderate-to-vigorous aerobic and/or resistance exercise training on ≥4 days/week)

  • Are unwilling to be randomized to either ExT or STRETCH

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Group-based Yoga and Stretching
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
December 20, 2025

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G1C9
    Canada

    Active - Recruiting

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