Pilot Study of the Feasibility of an Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer

Duke University1 site in 1 countrySeptember 2021

ConditionsBreast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Duke University
Locations: 1
Primary Endpoint: Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to find out if a monitored group exercise program can increase strength, muscle mass and ability to move in women after treatment for early stage breast cancer.

Detailed Description

This trial will assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements in a group of women treated for early stage breast cancer with the goal of improving functional mobility, body composition, and strength after breast conservation therapy.

Registry

clinicaltrials.gov

Start Date

September 2021

End Date

September 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 30-70 years
•Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
•Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
•BMI \> 25 kg/m2 or body fat% greater or equal to 31%
•Participants must have abstained from smoking for at least 12 months
•Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment and have undergone a pregnancy test prior to initial of radiation therapy (standard protocol for radiation therapy). They should also consent to use adequate contraception during the course of the study.
•Women must be determined capable of engaging in resistance training as documented in treating radiation oncologist notes.
•Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
•Women must complete a Functional Mobility Screen (FMS) and determined safe to engage in the workout regimen by the study personnel.

Exclusion Criteria

•Any treatment with chemotherapy for recent breast cancer treatment
•Mastectomy and/or lymph node dissection
•Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, and hemoglobin A1c greater than 8.
•Diabetic condition requiring the usage of insulin
•Severe arthritic, joint, cardiovascular, or musculoskeletal condition
•Inability to perform body weight squat exercise without pain assessed by treating radiation oncologist
•History of myocardial infarction or coronary artery disease