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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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" |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female breast cancer survivors.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Grigoriadis, PhD | Contact | 773-508-3658 | ggrigoriadis@luc.edu |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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 |
| From enrollment to the end of intervention at 8 weeks |