Rowing Following Breast Cancer Chemotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer Survivors

Intervention / Treatment
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* Behavioral: Exercise training


Participation Criteria
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Eligibility Criteria
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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 chemotherapy 6 to 18 months prior to study enrollment absence of contraindications to exercise or study participation study clinician approval Exclusion Criteria: do not meet inclusion criteria completed chemotherapy and/or other cancer treatment within past 6 months (e.g., surgery or radiation). Ovarian suppression within past 6 months is allowed. receiving or scheduled to receive radiation therapy during study participation scheduled to receive surgery during study participation receiving or scheduled to receive other cancer treatment besides ovarian suppression during study participation lymphedema stage ≥ 2 prior to study enrollment 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) body mass index ≥ 40 kg/m2 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 aerobic exercise training in previous 6 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indoor Rowing<br>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<br>* This is a single site center-based supervised exercise intervention.<br>|
| No Intervention: Usual Care<br>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?
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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 | 
| % 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 | 
| 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 |