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RECRUITING
NCT05468034
NA

Exercise in Metastatic Breast Cancer: EMBody

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-04-26

Completion Date

2027-12

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

BEHAVIORAL

Exercise Intervention

Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.

Locations (6)

Yale Cancer Center

New Haven, Connecticut, United States

IU Health West

Avon, Indiana, United States

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, United States

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States