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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05867667
Other study ID # UMCC 2023.010
Secondary ID HUM00230386
Status Recruiting
Phase N/A
First received
Last updated
Start date March 19, 2024
Est. completion date August 2025

Study information

Verified date March 2024
Source University of Michigan Rogel Cancer Center
Contact Anna Lamport
Phone 734-764-3832
Email alamport@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Michigan Rogel Cancer Center Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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