RecruitingNot ApplicableNCT05913713

HIIT Following Breast Cancer Chemotherapy

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


Sponsor

University of Florida

Enrollment

158 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Inclusion Criteria11

  • female patients based on biological sex
  • 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
  • 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)

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.


Locations(1)

Integrative Cardiovascular Physiology Laboratory, University of Florida

Gainesville, Florida, United States

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NCT05913713


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