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

NCT07517224 | Not Yet Recruiting

• 1 other identifier: 219222
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer Survivors

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 24-hour Ambulatory Blood Pressure

  From enrollment to the end of intervention at 8 weeks

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Other: Aerobic Exercise

Interventions

Aerobic Exercise OTHER

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.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female breast cancer survivors.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current pregnant and lactating patients. Must have completed lactation prior to study start.
• Metastatic disease.
• 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%.
• History of prior chemotherapy received for other cancer diagnosis.
• Non-English speaking

Sponsors & Collaborators

• Loyola University: lead

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Georgios Grigoriadis, PhD

CONTACT

773-508-3658; ggrigoriadis@luc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2035
• Last Updated: April 8, 2026

Record last verified: 2026-04