Cardiac Rehabilitation to Improve Breast Cancer Outcomes

Study Overview
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Brief Summary
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To develop a novel, proactive cardiac rehabilitation program for breast cancer survivors at enhanced risk of cardiovascular disease. Considering this program is secondary to the Michigan Medicine Cardiac Rehabilitation program's goal to manage cardiac patients, the hybrid program has been designed that limits utilization of cardiac rehabilitation to 12 visits over the first eight weeks of the intervention compared to 32 visits for cardiovascular patients.

Official Title
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Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)

Conditions
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Breast Cancer, Cardiovascular Diseases

Intervention / Treatment
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* Other: Cardiac Rehab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer diagnosis stage I-III Within 18-months of treatment completion (defined as completion of all oncologic treatments expect oral maintenance therapy) Age 18 years or older At increased risk for cardiovascular disease based on one of the following; a.Treatment with either anthracycline-based or anti-HER2 therapy-based treatment regimen plus the presence of: >2 cardiovascular heart disease risk factors (smoking, hypertension, diabetes mellitus, obesity, dyslipidemia), OR Age (>60 years) at cancer treatment, OR Left ventricular ejection fraction <50%as determined with a clinically ordered echo scan within 6 months of enrollment, b.Treatment with anthracycline followed by trastuzumab Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Planned surgery during the study period. Under cardiology care for known high-risk cardiovascular disease defined as the presence of any of the following: severe, unrevascularized coronary artery disease, severe valvular heart disease, advanced heart failure with a left ventricular ejection fraction <35%) Metastatic cancer Unable to exercise (e.g., inability to complete a modified stress test or musculoskeletal condition that prevents adequate participation in exercise) Adults unable to give consent, pregnant or lactating women, and prisoners are excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Rehabilitation to Improve Breast Cancer Outcomes<br>12 weeks of Cardiac Rehab | Other: Cardiac Rehab<br>* Cardiac Rehab 2x per week and home exercise 1x per week: weeks 1-4 Cardiac Rehab 1x per week and home exercise 2x per week: weeks 5-8, Home exercise 3x per week: weeks 9-12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiovascular fitness (as assessed using VO2max) between baseline and after 12 weeks of participation in a tapered 12-week cardiac rehabilitation program. | Change in cardiovascular fitness will be based on endpoints related to aerobic and anaerobic thresholds, including an increase in post maximal oxygen consumption (VO2max). VO2max will be assessed by indirect calorimetry (COSMED) during a graded exercise stress test using the Bruce protocol. | up to 12 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in upper body strength between baseline and after a 12-week hybrid cardiac rehabilitation program. | Change in muscular strength will be assessed using 5-RM tests. The tests will be performed for leg extension, leg flexion, chest press, lat pull down, and bicep curl. | up to 12 weeks after enrollment | 
| changes in lower body strength between baseline and after a 12-week hybrid cardiac rehabilitation program. | Change in muscular strength will be assessed using 5-RM tests. The tests will be performed for leg extension, leg flexion, chest press, lat pull down, and bicep curl. | up to 12 weeks after enrollment |