RecruitingNot ApplicableNCT05468034

Exercise in Metastatic Breast Cancer: EMBody

Sponsor

Indiana University

Enrollment

100 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Indolent Metastatic Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called EMBody, is investigating the effects of exercise on quality of life, physical function, and disease outcomes in people living with metastatic breast cancer (breast cancer that has spread to other parts of the body). **You may be eligible if...** - You have been diagnosed with metastatic breast cancer - You are currently receiving treatment for metastatic breast cancer - You are physically able to participate in an exercise program with medical supervision **You may NOT be eligible if...** - You have bone metastases in locations that make exercise unsafe (such as the spine or weight-bearing bones at high fracture risk) - You have uncontrolled heart disease or other serious conditions that prevent exercise - Your doctor has advised against physical activity Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise 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.