EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast CA

Completed

• Conditions: Breast Cancer Female

• Registration Number: NCT05747209
• Lead Sponsor: Colin Champ, MD

Brief Summary

The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. The main questions it aims to answer are:

* Is resistance training feasible following breast cancer treatment

* Can it improve the body's mobility and strength lost as a result of the breast cancer treatment

* can it improve the body's composition (for example muscle mass)

* can resistance training increase one's activity level and help prevent weight gain, perhaps, lowering the risk of cancer recurrence.

Participants will attend a group resistance training exercise group program, 3-4 times per week, under close supervision with monitoring a participant's ability to safely and effectively complete the program. The exercises include: lunges, squats and dead lifts.

Detailed Description

Obesity and low muscle mass, i.e. poor body composition, is a risk factor for breast cancers and disease recurrence after treatment. Furthermore, weight gain during and after treatment for breast cancer is associated with higher risk of recurrence, distant metastases, and death. Activity levels have been repeatedly associated with a lower risk of cancer incidence, improved outcomes after cancer treatment and improved overall survival, yet the majority of breast cancer survivors do not meet adequate daily activity level recommendations.

This protocol seeks to prospectively follow forty (40) female breast cancer patients (ages 20-95) during exercise who are post-cancer treatment and to assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment. This regimen is a standard of care regimen utilized in strength and conditioning protocols. The investigators hypothesize that an observed exercise regimen such as this will prove safe and feasible in women and may improve functional mobility, body composition and resting metabolic rate.

The exercise regimen will utilize a mixture of compound movements utilizing mainly closed kinetic chain movements (CKC), focusing on exercises with the goal of improving physical and metabolic function, mobility, muscle mass and body composition utilizing guidelines from the National Strength and Conditioning Association (NSCA). CKC exercises include lunges, squats, and dead lifts.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2023-02-25
• Study First Posted: 2023-02-28
• Results First Submitted: 2024-04-29
• Primary Completion: 2024-08-13
• Study Completion: 2024-09-19
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Results First Posted: 2025-06-24
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

1. Age 20-89 years
2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
3. Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
4. Participants must have abstained from smoking for at least 12 months
5. Women of child-bearing potential must have had a pregnancy test prior to initiation of radiation therapy (standard protocol for radiation therapy); verbally confirm lack of pregnancy prior to enrollment; and, consent to use adequate contraception during the course of the study.
6. Participants must be determined capable of engaging in resistance training.
7. Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
8. Participants must complete a Functional Mobility Screen (FMS) and be determined safe to engage in the workout regimen by the study exercise personnel.
9. Participants must be determined capable of engaging in group resistance training sessions by exercise personnel and/or study PI
10. Participants must be able to get down and up from the ground and squat their body weight.

Exclusion Criteria

1. Any treatment with chemotherapy for breast cancer
2. Inability to get and down off the ground or squat body weight
3. Inability to safely engage in group sessions
4. Severe arthritic, joint, cardiovascular, or musculoskeletal condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Movement Screen	Baseline and Three (3) months	A functional movement screen will be performed pre and post regimen to assess change in overall score; Functional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of "if any pain felt by the subject during the movement", "subject is unable to perform the movement", "subject performs the movement through compensatory movements", and "subject performs the movement correctly", respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome.
Changes in Strength From Baseline Through Study Completion, up to 3 Months	Baseline and months 1, 2, and 3	Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets at the end of months 1, 2, and 3.
Session Attendance	Baseline and Three (3) months	Calculated as the percentage of participants completing at least 75% of the planned exercise sessions. Dropout rate, defined as individuals who quit the workout regimen altogether, is expected to be less 20%.
Change in Adipose Tissue (InBody, kg)	Baseline and Three (3) months	Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis. Values reported are median changes with interquartile range (IQR).
Change in Adipose Tissue (Ultrasound, Lbs)	Baseline and Three (3) months	Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR).
Change in Muscle Mass	Baseline and Three (3) months	Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months.
Change in Fat-Free Mass	Baseline and Three (3) months	Changes in percent fat-free mass (measured by ultrasound) from baseline to three months.
Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels	Baseline and Three (3) months	EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) test pre and post regimen. This test is a descriptive system that is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There is an additional question measuring an individual's current overall health-related quality of life. Total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). Calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes. There is an additional question scored from 0 to 100 recorded for their current overall health-related quality of life. 100 means the best health and 0 means the worst health they can imagine.
Activity Levels Via Godin Questionnaire	3 months	Change in activity levels measured by Godin Questionnaire pre and post regimen, specifically strenuous, moderate and mild/light exercise with a score from 0 to unlimited. The Godin scale score lists 24 or more units of exercise as active, 14-23 units as moderately active, and less than 14 units as insufficiently active/sedentary
Resting Metabolic Rate as Calories Burned Per Day	Baseline and Three (3) months	Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis.
Y-balance Score	Baseline and Three (3) months	A Y-balance test will be performed pre and post regimen to assess change; Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.

Secondary Outcome Measures

Name	Time	Method
Participants Will Undergo an Assessment 1 Year Following the Exercise Program.	12 months	Participants will be assessed 1 year following exercises as they were at baseline and post exercise as Standard of Care (SOC). The SOC assessments will encompass weight, height, BMI, body composition, resting metabolic rate, quality of life questionnaires and exercise forms, strength, and mobility

Trial Locations

Locations (1)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States