Assessing the Effect of an Aerobic Exercise Program on Vascular Function in Women With Non-Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic Exercise.
- Who it may be relevant to
- Registry conditions: Breast Cancer Survivors. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Enrollment (Recruitment rate) [Time frame: From enrollment to immediately after first visit]
- Participant adherence - Proportion of people considered adherent [Time frame: From enrollment to the end of intervention at 8 weeks]
- Retention - Proportion of survivors who completed the study [Time frame: From enrollment to the end of intervention at 8 weeks]
- Pulse Wave Velocity [Time frame: From enrollment to the end of intervention at 8 weeks"]
- Aortic Blood Pressure [Time frame: From enrollment to the end of intervention at 8 weeks]
Secondary outcome measures (1)
- Blood Pressure [Time frame: From enrollment to the end of intervention at 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07517224 · 219222