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.
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 Type
OBSERVATIONAL
Enrollment
43
Observation of a monitored group exercise regimen utilizing standard of care 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 to study adherence and attendance to the exercise program.
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Session Attendance
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%.
Time frame: Baseline and Three (3) months
Change in Adipose Tissue (InBody, kg)
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).
Time frame: Baseline and Three (3) months
Change in Adipose Tissue (Ultrasound, Lbs)
Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR).
Time frame: Baseline and Three (3) months
Change in Muscle Mass
Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months.
Time frame: Baseline and Three (3) months
Change in Fat-Free Mass
Changes in percent fat-free mass (measured by ultrasound) from baseline to three months.
Time frame: Baseline and Three (3) months
Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels
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.
Time frame: Baseline and Three (3) months
Activity Levels Via Godin Questionnaire
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
Time frame: 3 months
Resting Metabolic Rate as Calories Burned Per Day
Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis.
Time frame: Baseline and Three (3) months
Functional Movement Screen
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.
Time frame: Baseline and Three (3) months
Y-balance Score
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.
Time frame: Baseline and Three (3) months
Changes in Strength From Baseline Through Study Completion, up to 3 Months
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.
Time frame: Baseline and months 1, 2, and 3
Participants Will Undergo an Assessment 1 Year Following the Exercise Program.
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
Time frame: 12 months
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