In this study, the investigators hypothesize that a high dose of post-workout protein nutrition regimen focused on food quality and an observed exercise regimen utilizing high-load resistance training initiated during or after cancer treatment will improve body composition and functional capacity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
20 grams of whey protein
60 grams of whey protein.
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGChanges in muscle mass and fat mass (pounds) at completion of chemotherapy
Time frame: Baseline and at program completion (within 4 weeks of exercise completion).
Response to Chemotherapy Assed Via the Guidelines or the Response evaluation criteria in solid tumors (RECIST)
Response to chemotherapy will be assessed via the guidelines or the Response evaluation criteria in solid tumors (RECIST) criteria version 1.1 before and after chemotherapy with radiographic interpretation on either MRI of the breast or, if unable to get an MRI, PET/CT scan.
Time frame: Chemotherapy response assessment is at program completion (within 4 weeks of exercise completion)
Changes in EuroQol-5 Dimensions (EQ-5D) at completion of chemotherapy assessment
EuroQol-5 Dimensions-5 Levels total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). This is 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.
Time frame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in Patient Health Questionnaire-9 (PHQ9) depression score at completion of chemotherapy assessment
Patient Health Questionnaire-9 total score for the 9 questions ranges from 0 (no depression) to 27 (highest level of depression). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.
Time frame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in General Anxiety Disorder-7 (GAD7) anxiety score at completion of chemotherapy assessment
General Anxiety Disorder-7 total score for the seven questions ranges from 0 (no anxiety) to 21 (highest level of anxiety). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.
Time frame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in activity levels via Godin Leisure-Time Exercise Questionnaire
Godin Leisure-Time Exercise Questionnaire is used to measure a person's frequency and intensity of exercise during a typical week. A Godin Scale Score of 24 units or more is interpreted as Active, 14 - 23 units is Moderately Active, and less than 14 units is Insufficiently Active/Sedentary.
Time frame: Baseline assessment (prior to program) and at exercise program completion (at 24 weeks).
Changes in resting metabolic rate at completion of chemotherapy
Time frame: Baseline and at program completion (within 4 weeks of exercise completion).
Changes in body composition at completion of chemotherapy, including fat-free mass in pounds.
Time frame: Baseline and at program completion (within 4 weeks of exercise completion).
Changes in Y-Balance Test Scores at baseline and at completion of chemotherapy
Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.
Time frame: Baseline and at program completion (within 4 weeks of exercise completion).
Changes in Functional Mobility Score at baseline and at completion of chemotherapy
During the test, 7 movement patterns are assessed and each one is rated between 0 and 3 by an examiner. These movements include the deep squat, hurdle step, inline lunge, shoulder mobility test, active straight leg raise, trunk stability push up, and rotary stability test. A score of zero is given if any pain is felt during the movement, 1 if the subject is unable to perform the movement, 2 if the subject performs the movement through compensatory movements, and 3 if the movement is performed correctly. Each movement score is summed and a final score out of 21 is calculated. A score below 14 is felt to identify individuals at risk of injury.
Time frame: Baseline and at program completion (within 4 weeks of exercise completion).
Changes in phase angle at completion of chemotherapy
Phase angle is calculated via bioimpedance analysis and is measured in degrees.
Time frame: At program completion (at 24 weeks)
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