HIIT Following Breast Cancer Chemotherapy

Study Overview
=================
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.

Official Title
-----------------
High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: 12-week Intervention Period
* Behavioral: 12-week Observation Period


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients based on biological sex 18 to 85 years of age diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 12 months prior to study enrollment absence of contraindications to exercise or to participate in study study clinician approval Exclusion Criteria: do not meet inclusion criteria completed chemotherapy and/or other cancer treatment (e.g., surgery or radiation) besides ovarian suppression within 6 months of study enrollment scheduled to receive surgery, radiation therapy or other cancer treatment besides ovarian suppression during the study period lymphedema stage ≥2 prior to study enrollment 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) are pregnant current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss) consistent participation over the past 6 months in moderate-intensity aerobic exercise training for ≥150 min/week

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training (HIIT)<br>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<br>* 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.<br>Behavioral: 12-week Observation Period<br>* 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.<br>|
| Experimental: Moderate Intensity Continuous Training (MICT)<br>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<br>* 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.<br>Behavioral: 12-week Observation Period<br>* 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.<br>|
| Other: Usual Care (UC)<br>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<br>* 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.<br>Behavioral: 12-week Observation Period<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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 |