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High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy

NCT ID: NCT05913713Sponsor: University of FloridaLast updated: 2025-11-21

Summary

Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.

Arms & interventions

  • Behavioral12-week Intervention Period

    Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.

  • Behavioral12-week Observation Period

    After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.

Outcome measures

Primary

  • Change in brachial FMD

    Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.

    Time frame: Baseline, Following a 12-week intervention period, Following a 12-week observation period

  • Change in cardiac function (global longitudinal strain)

    Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.

    Time frame: Baseline, Following a 12-week intervention period, Following a 12-week observation period

  • Percent completed vs. planned exercise frequency

    The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.

    Time frame: Throughout the 12 weeks of supervised home-based exercise training

  • Percent completed vs. planned exercise duration

    The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.

    Time frame: Throughout the 12 weeks of supervised home-based exercise training

  • Percent completed vs. planned exercise intensity

    The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.

    Time frame: Throughout the 12 weeks of supervised home-based exercise training

  • Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention

    To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.

    Time frame: Throughout the 12 weeks of supervised home-based exercise training

Eligibility criteria

Sex: FemaleAge: 18 Years to 85 YearsHealthy volunteers: No
Inclusion Criteria: * female patients based on biological sex * 18 to 85 years of age * diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer * completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation * absence of contraindications to exercise or to participate in study * study clinician approval Exclusion Criteria: * do not meet inclusion criteria * scheduled to receive surgery or radiation therapy during the intervention period * any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent) * lymphedema stage ≥2 prior to study enrollment * are pregnant * current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)

Study locations (1)

Integrative Cardiovascular Physiology Laboratory, University of Florida

Gainesville, Florida, 32611

Recruiting
Demetra Christou, PhD · Contact
352-294-1746ddchristou@ufl.edu