Assessing the Effect of an Aerobic Exercise Program on Vascular Function in Women With Non-Metastatic Breast Cancer

The goal of this clinical trial is to assess the feasibility of an 8-week aerobic exercise program and its effect on arterial function in breast cancer survivors.

The main questions it aims to answer are:

• Is an 8-week aerobic exercise program feasible in breast cancer survivors after the completion of chemotherapy?
• Is this 8-week aerobic exercise program beneficial for vascular function in breast cancer survivors?

Participants will:

• Begin an 8-week aerobic exercise program, three days per week, after the completion of chemotherapy.
• Visit our facility three times before the exercise program, 1 month after, and after the completion of the program.
• Complete questionnaires, physical functional tests, and body composition and vascular measurements at every visit.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Other: Aerobic Exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgios Grigoriadis, PhD; Phone Number: 773-508-3658; Email: ggrigoriadis@luc.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Women (18+ years) with a stage I-III breast cancer diagnosis who have completed chemotherapies.
2. Completed the final chemotherapy cycle within the past 4 weeks.
3. Sedentary by self-reporting inactivity (<90 min of moderate or vigorous exercise per week)
4. Body mass index ≤40 kg/m²
5. Willing to complete all study activities
6. Able to safely participate in moderate aerobic exercise.

Exclusion Criteria:

1. Current pregnant and lactating patients. Must have completed lactation prior to study start.
2. Metastatic disease.
3. Diagnosed cardiovascular disease prior to the initiation of chemotherapy, as evidenced by cardiomyopathy (reduced regional or global left ventricular contractility), diastolic dysfunction grade 2 or above, symptomatic coronary artery disease, ejection fraction below 50%.
4. History of prior chemotherapy received for other cancer diagnosis.
5. Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention	Other: Aerobic Exercise; Participants will perform aerobic exercise three times per week for 8 weeks, with each session consisting of 30 minutes at 40-59% of heart rate reserve (HRR). Each session will also include a 10-minute warm-up and a 5-minute cool-down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment (Recruitment rate)	Enrollment will be measured by the proportion of eligible breast cancer survivors who provide informed consent to participate in the study. The proportion of enrolled participants will be reported.	From enrollment to immediately after first visit
Participant adherence - Proportion of people considered adherent	Adherence will be measured as the proportion of exercise sessions completed by consented survivors out of the total of 24 prescribed training sessions. Completion of at least 18 of the 24 training sessions will be considered adherent.	From enrollment to the end of intervention at 8 weeks
Retention - Proportion of survivors who completed the study	Retention will be measured by the percentage of consented survivors that completed the research study compared to the total number initially enrolled. The proportion of survivors who completed the study will be reported.	From enrollment to the end of intervention at 8 weeks
Pulse Wave Velocity	This test measures how stiff your arteries are (called pulse wave velocity). Pulse wave velocity is an important measure that can help predict the risk of heart and blood vessel disease. It is a simple, non-invasive test, which means it does not involve needles or anything that goes inside your body. We will use a device called the SphygmoCor XCEL to do the test. To measure this, we will place a small sensor on your neck (over the carotid artery) and a blood pressure cuff on your upper thigh (over the femoral artery). The cuff will inflate slightly while we record your pulse waves. We will also use a tape measure to find the distance between the two spots. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.	From enrollment to the end of intervention at 8 weeks"
Aortic Blood Pressure	We will use a simple, non-invasive test to estimate the aortic blood pressure with a device called the SphygmoCor XCEL. The device measures your blood pressure using a cuff placed on your upper arm. Aortic blood pressure is another test we use to check the health of the heart and blood vessels. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.	From enrollment to the end of intervention at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour Ambulatory Blood Pressure	Participants will be asked to wear a blood pressure cuff on your arm with a small monitoring recording pack (ABPMpro device). The machine will take a blood pressure measurement every 15-30 minutes while they are awake and every 30-60 minutes while they are sleep. Participants will wear it everywhere, except for in the shower, for a full 24 hours. The 24-hour ambulatory blood pressure test gives a reliable measurement of the blood pressure, which is an important way to check your heart and blood vessel health This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.	From enrollment to the end of intervention at 8 weeks

Collaborators and Investigators

• Sponsor: Loyola University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2035

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 219222

Drug and device information, study documents

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