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RecruitingInterventional

Indoor Rowing as a Novel Exercise Therapy for Cardiovascular Rehabilitation in Middle-Aged and Older Breast Cancer Survivors Following Chemotherapy

NCT ID: NCT05848141Sponsor: University of FloridaLast updated: 2025-08-17

Summary

There are more than 3.8 million breast cancer survivors in the United States and 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 of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.

Arms & interventions

  • BehavioralExercise training

    This is a single site center-based supervised exercise intervention.

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 12 weeks of supervised exercise training

  • Change in 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 12 weeks of supervised exercise training

  • % completed vs. planned exercise frequency

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

    Time frame: Throughout the 12 weeks of supervised exercise training

  • % completed vs. planned exercise duration

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

    Time frame: Throughout the 12 weeks of supervised exercise training

  • % completed vs. planned exercise intensity

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

    Time frame: Throughout the 12 weeks of supervised exercise training

  • Number of participants who experience adverse event as defined by most recent CTCAE

    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 exercise training

Eligibility criteria

Sex: FemaleAge: 40 Years to 80 YearsHealthy volunteers: No
Inclusion Criteria: * diagnosis of primary invasive non-metastatic breast cancer, stages I-III * female based on biological sex * 40 to 80 years of age * completed breast cancer treatment 6 to 24 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 prior to study enrollment and during study participation * absence of contraindications to exercise or study participation * study clinician approval Exclusion Criteria: * do not meet inclusion criteria * receiving or scheduled to receive treatment for breast cancer (i.e., chemotherapy, surgery, or radiation) during study participation is not allowed. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed during study participation * lymphedema stage ≥ 2 prior to study enrolment * 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) * current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss) * consistent participation in ≥150 min/week of moderate-intensity rowing exercise training in previous 6 months

Study locations (1)

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, 32611

Recruiting
Demetra Christou, PhD · Contact
352-294-1746ddchristou@ufl.edu
Rowing Following Breast Cancer Chemotherapy | Cancerify