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NCT Number: NCT07517224

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.

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Key information

Conditions

Breast Cancer Survivors

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women (18-70 years) with a stage I-III breast cancer diagnosis who have completed chemotherapies.
  • Able to begin aerobic exercise within 4 weeks of the final chemotherapy cycle.
  • Sedentary by self-reporting inactivity (<90 min of moderate or vigorous exercise per week)
  • Weight ≤154 kg
  • Willing to complete all study activities
  • Able to safely participate in moderate aerobic exercise.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Enrollment (Recruitment rate)

    Time frame: From enrollment to immediately after first visit

    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.

  2. Participant adherence - Proportion of people considered adherent

    Time frame: From enrollment to the end of intervention at 8 weeks

    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.

  3. Retention - Proportion of survivors who completed the study

    Time frame: From enrollment to the end of intervention at 8 weeks

    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.

  4. Pulse Wave Velocity

    Time frame: From enrollment to the end of intervention at 8 weeks"

    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.

  5. Aortic Blood Pressure

    Time frame: From enrollment to the end of intervention at 8 weeks

    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.

Secondary outcomes

  1. Blood Pressure

    Time frame: From enrollment to the end of intervention at 8 weeks

    Participants will be asked to wear a blood pressure cuff on their arm with a small monitoring recording pack (ABPMpro device). The device will take measurements every 2 minutes. Participants will undergo two blood pressure measurements. If the two measurements are not within 5 mmHg for both systolic and diastolic blood pressure, additional measurements will be obtained until this criterion is satisfied. The blood pressure device 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Grigoriadis, PhD

CONTACT

[email protected]

773-508-3658

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2035
First posted
Apr 8, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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