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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG078995-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. |
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| Moderate Intensity Continuous Training (MICT) | Experimental | Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. |
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| Usual Care (UC) | Other | Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week Intervention Period | Behavioral | Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brachial FMD | Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. | Baseline, Following a 12-week intervention period, Following a 12-week observation period |
| Change in cardiac function (global longitudinal strain) | Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction. | Baseline, Following a 12-week intervention period, Following a 12-week observation period |
| Percent completed vs. planned exercise frequency | The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week. | Throughout the 12 weeks of supervised home-based exercise training |
| Percent completed vs. planned exercise duration | The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session. | Throughout the 12 weeks of supervised home-based exercise training |
| Percent completed vs. planned exercise intensity | The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session. | Throughout the 12 weeks of supervised home-based exercise training |
| Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention |
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Inclusion Criteria:
Exclusion Criteria:
Women who received chemotherapy for breast cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Demetra Christou, PhD | Contact | 352-294-1746 | ddchristou@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Demetra Christou, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Cardiovascular Physiology Laboratory, University of Florida | Recruiting | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 12-week Observation Period | Behavioral | After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises. |
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To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions. |
| Throughout the 12 weeks of supervised home-based exercise training |
| D017437 |
| Skin and Connective Tissue Diseases |