HIIT Following Breast Cancer Chemotherapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Intensity Interval Training (HIIT) Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. |
Behavioral: 12-week Intervention Period
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.
Behavioral: 12-week Observation Period
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.
|
| Experimental: Moderate Intensity Continuous Training (MICT) Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks. |
Behavioral: 12-week Intervention Period
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.
Behavioral: 12-week Observation Period
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.
|
| Other: Usual Care (UC) 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). |
Behavioral: 12-week Intervention Period
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.
Behavioral: 12-week Observation Period
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.
|
Outcome Measures
Primary Outcome Measures
- Change in brachial FMD [Baseline, Following a 12-week intervention period, Following a 12-week observation period]
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.
- Change in cardiac function (global longitudinal strain) [Baseline, Following a 12-week intervention period, Following a 12-week observation period]
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.
- % completed vs. planned exercise frequency [Throughout the 12 weeks of supervised home-based exercise training]
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
- % completed vs. planned exercise duration [Throughout the 12 weeks of supervised home-based exercise training]
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
- % completed vs. planned exercise intensity [Throughout the 12 weeks of supervised home-based exercise training]
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
- Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention [Throughout the 12 weeks of supervised home-based exercise training]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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female patients based on biological sex
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18 to 85 years of age
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diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer
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completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 12 months prior to study enrollment
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absence of contraindications to exercise or to participate in study
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study clinician approval
Exclusion Criteria:
-
do not meet inclusion criteria
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completed chemotherapy and/or other cancer treatment (e.g., surgery or radiation) besides ovarian suppression within 6 months of study enrollment
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scheduled to receive surgery, radiation therapy or other cancer treatment besides ovarian suppression during the study period
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lymphedema stage ≥2 prior to study enrollment
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any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
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current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
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consistent participation over the past 6 months in moderate-intensity aerobic exercise training for ≥150 min/week
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Integrative Cardiovascular Physiology Laboratory, University of Florida | Gainesville | Florida | United States | 32611 |
Sponsors and Collaborators
- University of Florida
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Demetra Christou, PhD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB202300460 -N
- 1R21AG078995-01A1