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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HL152264-01A1 | U.S. NIH Grant/Contract | View source | |
| PRO00031309 | Other Identifier | University of Florida | |
| OCR40536 | Other Identifier | UF OnCore |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All-extremity exercise | Experimental |
| |
| Treadmill exercise | Active Comparator |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Behavioral | Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in brachial artery 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. | 12 weeks |
| Change in 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. | 12 weeks |
| Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy | To evaluate the feasibility, tolerability and safety of all-extremity exercise compared with treadmill exercise in breast cancer patients undergoing chemotherapy, we will collect comprehensive information throughout the exercise intervention: completed vs. planned exercise dose (intensity/session, min/session, sessions/week), reasons for missed/partially completed sessions or study withdrawal, adverse events, and disease- and treatment-related outcomes. To specifically evaluate safety, should an adverse event occur, plans are in place for determination and monitoring 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. | Monitored throughout the 12 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
Women who will receive chemotherapy for breast cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Demetra Christou, PhD | Contact | 3522941746 | ddchristou@ufl.edu | |
| Eileen Handberg | Contact | 352-273-9082 | handbem@medicine.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Demetra Christou, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Cardiovasculal 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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| 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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| D017437 |
| Skin and Connective Tissue Diseases |