Rowing Following Breast Cancer Chemotherapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Behavioral: Exercise training

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Demetra Christou, PhD; Phone Number: 352-294-1746; Email: ddchristou@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • Integrative Cardiovasculal Physiology Laboratory, University of Florida
      • Contact: Demetra Christou, PhD; Phone Number: 352-294-1746; Email: ddchristou@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indoor Rowing; Research participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks.	Behavioral: Exercise training; This is a single site center-based supervised exercise intervention.
No Intervention: Usual Care; Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Following 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.	Throughout the 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.	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.	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.	Throughout the 12 weeks of supervised exercise training

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Demetra Christou, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB202201237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No