Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)

Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)

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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Breast Cancer
• Intervention / Treatment: Other: Cardiac Rehab

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Rehabilitation to Improve Breast Cancer Outcomes; 12 weeks of Cardiac Rehab	Other: Cardiac Rehab; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: David Lipps, PhD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): August 13, 2024
• Study Completion (Actual): August 13, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Cardiovascular Diseases; Breast Neoplasms
• Other Study ID Numbers: UMCC 2023.010; HUM00230386 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No