Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast Cancer
Conditions: Breast Cancer Female
Sponsor: Colin Champ, MD

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EXERT-BC: ProspecƟve study of an EXErcise Regimen 
designed to improve funcƟonal mobility, body 
composiƟon, and strength aŌer Treatment for Breast 
Cancer 
 
NCT number: NCT05747209 
 
Document Date: 12/14/2023 
 
 
 

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EXERT-BC: Prospective study of an EXErcise Regimen designed to improve functional 
mobility, body composition, and strength after Treatment for Breast Cancer 
 
 
Principal Investigator 
Colin E. Champ, MD, CSCS 
Colin.champ@ahn.org 
Allegheny Health Network 
Dept. of Radiation Oncology 
AHNCI Exercise Oncology and Resiliency Center 
 
Investigators: 
Allegheny Health Network: 
 
Sushil Beriwal, MD, MBA 
Department of Radiation Oncology 
 
Christie Hilton, DO 
Department of Medical Oncology 
 
Other Personnel: 
Frank Velasquez, ATC, CSCS 
Krista Matsko, MS, CSCS 
AHN Sports Performance and Physical Therapy Center 
 
Consultants: 
Parkey Hyde, PhD, CSCS 
Department of Kinesiology, Georgia Southern University 
 
Jared Rosenberg, MS, CSCS                                                            
Department of Exercise Science, Syracuse University 
 
 
 
 
 
 
 
 

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1 TABLE OF CONTENTS 
1 TABLE OF CONTENTS ....................................................................................................................... 3 
2.  LIST OF ABBREVIATIONS ................................................................................................................. 5 
3 PROTOCOL SYNOPSIS ...................................................................................................................... 6 
3.1 
Purpose: ...................................................................................................................... 6 
3.2 
Background and Significance: ..................................................................................... 6 
3.3 
Rationale: .................................................................................................................... 8 
3.4   Design and Procedure: .................................................................................................. 9 
3.5   Selection of Subjects and Sample Size: ......................................................................... 9 
3.6   Duration of Study: .......................................................................................................... 9 
4.  SUBJECT ELIGIBILITY ..................................................................................................................... 10 
4.1 Inclusion Criteria: ............................................................................................................10 
4.2 Exclusion Criteria: ...........................................................................................................10 
5.  EXERCISE REGIMEN ....................................................................................................................... 10 
5.1 Location: .........................................................................................................................10 
5.2 Personnel: ......................................................................................................................10 
5.3 Exercise Regimen: ..........................................................................................................11 
6.  PATIENT ASSESSMENTS ............................................................................................................... 12 
6.1 Screening Assessments .................................................................................................13 
6.3 Exercise Period: ..............................................................................................................14 
6.4 Follow-up Period: ............................................................................................................14 
There will be no follow-up once an individual completes the study. .......................................14 
6.5 Early Withdrawal of Subject(s): .......................................................................................14 
6.5.1 Criteria for Early Withdrawal .................................................................................................... 14 
6.5.2 Follow-up Requirements for Early Discontinuation .............................................................. 15 
6.5.3 Replacement of Early Withdrawal(s) ...................................................................................... 15 
7.   STATISTICAL METHODS AND DATA ANALYSIS ...................................................................... 15 
7.1. Analysis of Safety ..........................................................................................................15 
7.2 Analysis of Adherence ....................................................................................................15 
8.  SAFETY MONITORING AND REPORTING .................................................................................. 16 
8.1 Adverse Events and Serious Adverse Events: ................................................................16 
9.  QUALITY CONTROL AND QUALITY ASSURANCE .................................................................... 16 

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9.1   Monitoring: ....................................................................................................................16 
10.  ADMINISTRATIVE AND ETHICAL CONSIDERATIONS ........................................................... 16 
10.1 Regulatory and Ethical Compliance: .............................................................................16 
10.2 Informed Consent: ........................................................................................................16 
10.3 Study Documentation: ...................................................................................................17 
10.4 Privacy, Confidentiality, and Data Storage: ...................................................................17 
10.5 Protocol Amendments: ..................................................................................................18 
10.6 Records Retention: .......................................................................................................19 
APPENDIX I: References .....................................................................................................20 
APPENDIX II: Quality of Life – EQ-5D-5L .............................................................................24 
APPENDIX III: Strength Assessment ....................................................................................26 
APPENDIX IV: GODIN LEISURE-TIME EXERCISE QUESTIONNAIRE ...............................27 
APPENDIX V: Functional Movement Screen and Y-Balance Test ........................................28 
APPENDIX VI: Body Composition Testing ............................................................................29 
 
 
 

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2.  LIST OF ABBREVIATIONS 
 
 
AE 
 
Adverse event 
BMI   
Body mass index 
CKC  
Closed Kinetic Chain 
CLIA  
Clinical Laboratory Improvement Amendments 
CMP  
Comprehensive metabolic panel 
CPC  
Cancer Protocol Committee 
CRF  
Case report form 
CSCS  
Certified Strength and Conditioning Specialist 
DEXA  
Dual energy x-ray absorptiometry 
DSMB  
Data safety and monitoring board 
eCRF  
electronic case report form 
EPOC  
Excess post-exercise oxygen consumption 
FDA  
Food and Drug Administration 
GCP  
Good clinical practice 
ICH 
 
International Conference on Harmonization 
FACT-B4 
Functional Assessment of Cancer Therapy - Breast  
FMS  
Functional Mobility Screen 
IRB 
 
Institutional Review Board 
MET  
Metabolic equivalent of task 
NSCA  
National Strength and Conditioning Association 
OARC  
Office of Audit, Risk and Compliance 
OKC  
Open kinetic chain 
PI 
 
Primary investigator 
QOL  
Quality of Life 
RDSP  
Research Data Security Plan 
SAE  
Serious adverse event 
SOC  
Standard of Care  
SOP  
Standing operating procedures 
 

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3  PROTOCOL SYNOPSIS 
3.1 Purpose: 
This protocol seeks to analyze patient outcomes of the standard of care, monitored group 
exercise regimen of high-load resistance training and functional exercises with compound 
movements under close supervision on women who have been treated for breast cancer. 
 
Primary Objective 
1 Determine safety and feasibility measured by exercise compliance. 
 
Exploratory Objectives 
1 Determine changes in functional mobility testing changes at baseline, throughout,  
post-exercise assessment and 1 year after exercise assessment. 
2 Determine quality of life at baseline, throughout, and post- exercise assessment 
3 Determine changes in strength and load lifted at baseline, throughout, post- 
exercise assessment, and 1 year after exercise assessment. 
4 Determine changes in resting metabolic rate at baseline, throughout, post- 
exercise assessment, and 1 year after exercise assessment. 
5 Determine changes in body composition at baseline, throughout, post- exercise 
assessment and 1 year after exercise assessment, including body mass, fat mass, 
fat-free mass, % fat, and % fat-free mass. 
 
      Hypotheses 
In this study, we hypothesize that an observed exercise regimen utilizing high-load 
resistance training initiated during or after cancer treatment is safe and feasible in 
women and may improve functional mobility, body composition, and resting metabolic 
rate.  
 
 
3.2 Background and Significance: 
 
Obesity is a risk factor for both breast cancer and disease recurrence after 
treatment.1 Furthermore, weight gain during and after treatment for breast cancer is 
associated with a higher risk of recurrence, distant metastases, and death.2 Yet, most 
women gain significant weight during and after breast cancer treatment, potentially 
compromising outcomes.  
Contrary to these findings, activity levels have been repeatedly associated with a 
lower risk of breast cancer incidence, improved outcomes after breast cancer treatment, 
and improved breast cancer-specific and overall survival.3 The majority of breast cancer 
survivors do not meet adequate daily activity level recommendations, potentially 
compounding issues with weight gain during and after breast cancer treatment.4 As a 
result, attempts are underway to both quantify and increase activity levels during 
treatment and survivorship.5 Furthermore, and based on these findings, several areas of 

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research have attempted to analyze both diet and exercise regimens in women with 
breast cancer to reduce weight. Beyond solely assessing weight gain, other data reveal 
a close association between several metabolic factors and poorer outcomes after breast 
cancer treatment, including elevated serum glucose, decreased insulin sensitivity, 
elevated serum insulin, increased inflammatory factors, and decreased muscle mass.6–8 
These factors can be generally improved through specific targeted exercise training, 
suggesting metabolic benefits of exercise beyond simple weight loss. Furthermore, as 
resistance training improves strength, muscle hypertrophy, and body composition, and 
leads to physical and cellular changes that appear to counter these metabolic 
perturbations – often unrelated to changes in overall weight – such training may be a 
prudent strategy to improve measurable variables associated with breast cancer specific 
and overall health benefit.9–11 However, this approach differs from current exercise 
strategies that often aim to elicit cardiac benefits and calorie deficits through aerobic and 
extended activity that involves intermediate to low intensity exercises.12  
Moreover, studies in non-cancer populations reveal that exercise is generally 
minimally effective for weight loss, and specifically fat loss, when unaccompanied by other 
health changes.13 Simply relying on aerobic exercise to induce caloric deficit for weight 
loss in the oncologic setting may be concerning in as it can lead to loss of lean mass and 
muscle tissue,14 and the potential metabolic and functional benefits that accompany both. 
Studies reveal that resistance training requiring more intense effort may help support lean 
mass maintenance or even muscle gains during weight loss, which has been shown to 
simultaneously increase resting metabolic rate to increase fat oxidation and improve body 
composition.11,15 Such changes may be more advantageous in the oncologic setting than 
previous exercise strategies.  
For example a recent randomized trial of an unobserved home aerobic exercise 
regimen revealed no improvement in physical functioning in women with metastatic breast 
cancer, assessed via an array of physical tests.16 Another recent study in overweight 
women with breast cancer utilizing a 52-week, home-based exercise program consisting 
of lightweight strength and resistance training twice per week and 180 minutes of walking 
per week revealed no weight loss.17 Additionally, no improvement in aerobic fitness or 
strength tests was experienced by the women in the exercise group. Progression in 
resistance load during resistance training in the majority of studies has been slow with 
low loads to avoid exacerbating lymphedema.18 Yet, multiple studies have now confirmed 
no increase, and potentially improvement, in lymphedema in women undergoing 
resistance training after breast cancer treatment.17,19–21 For safety measures, many home 
exercise programs in breast cancer patients also utilize light-weight free-weights or open 
kinetic chain (OKC) movements where the body is fixed and the distal extremities are 
mobile (as in arm curls), both of which can often limit activation of core and accessory 
muscles, leading to a less intense regimen that may limit functional and mobility benefits 
and hypertrophy.22,23 Closed kinetic chain (CKC) exercises involve fixation of the distal 
aspect of the extremity (as in the squat), as opposed to proximal isolation (with OKC), 
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simultaneous muscles to stabilize the body during movement, also known as compound 
exercises. Such CKC exercises include lunges, squats, deadlifts, and power cleans; on 
the contrary, examples of OKC exercises are bench press, seated leg curls and 
extensions, and machine curls. CKC and compound exercises also mimic athletic 
movements, thus positively impacting mobility and function.  
Studies in non-cancer patients reveal that resistance training routines that expose 
muscle tissue to extensive mechanical tension with subsequent muscle damage and 
metabolic stress promote training-induced muscle growth.24 Additionally, more intense 
and heavier weight lifting regimens have been consistently shown to improve several 
factors associated with health, including: 1) Improved strength and fitness and decreased 
risk of injury, 2) Increased muscle mass and corresponding decrease in inflammation,25 
3) Enhanced insulin sensitivity, elevated resting metabolic rate, and decreased risk of 
diabetes,4 4) Improved mobility and overall health,26 and 5) Increased bone mineral 
density.27 Furthermore, resting metabolic rate, which comprises the majority of daily total 
energy expenditure, is proportional to muscle mass.28 Additionally, excess postexercise 
oxygen consumption (EPOC), or the continued enhanced metabolic effect after the 
completion of exercise, is enhanced via strenuous resistance training compared with 
aerobic training alone.29  
While weight training has clear advantages over aerobic training for improving 
body composition and several measurable metabolic variables, there have been barriers 
to its implementation in exercise regimens for the breast cancer patient, including 
concerns of safety and lymphedema risk.30 However, as stated above, these risks have 
been largely disproved by the current available research.31 Adverse effects (AEs) reported 
in prior exercise studies include typical self-limiting musculoskeletal issues, including 
muscle strains, joint and back pain, shin splints, and tendinitis.32 Overall, AEs are minimal. 
Furthermore, an observed environment with supervision by trained exercise personnel 
can further reduce the risk of injury,33,34 as can adaption of a workout regimen that 
accounts for individuals’ functional movement abilities, mobility, and function.35  
 
3.3 
Rationale: 
To date, the majority of exercise intervention studies for women with breast cancer 
after treatment focus on aerobic exercise regimens and/or low to moderate-intensity 
resistance training. Additionally, the components of resistance training often rely on 
isolated and open kinetic chain exercises utilizing light weights and high repetition 
schemes that may not be optimal for hypertrophy and improvement of functional 
movements.36 These regimens have generally been implemented with two major goals: 
1) Provide weight reduction, 2) Increase energy expenditure measured via metabolic 
equivalent of task (MET). Such goals are based on significant literature revealing 
improved outcomes after breast cancer treatment in physically active women and worse 
outcomes in women who gain weight during and after treatment.2 However, 

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mechanistically, it is unclear if these strategies are most prudent to improve health and 
breast cancer-specific outcomes.37  
 
There is a paucity of data utilizing and testing multiple-joint, closed kinetic chain, 
and compound exercises that rely on full body movements with the goal of improving 
strength, hypertrophy, and functional movement patterns in women after breast cancer 
treatment. This remains a concerning gap in the literature, as multiple studies in non-
cancer populations have revealed body composition and metabolic improvements 
following such weight training regimens. Additionally, studies reveal that observed 
exercise programs lead to enhanced strength gains and hypertrophy,38 and successful 
exercise interventions tend to be those that involve direct supervision.39 Finally, many of 
the exercise regimens tested include prolonged exercise regimens like treadmill and 
aerobic sessions lasting 90 minutes or more. More intense weight training generally lasts 
a fraction of this and may therefore serve as a time-effective method of exercise.  
 
Thus, this protocol will attempt to analyze patient outcomes of an observed 
exercise regimen utilizing high-load resistance training via compound CKC and functional 
resistance exercises with the goal of improving physical and metabolic function, mobility, 
muscle mass, and body composition in women previously treated for breast cancer 
utilizing guidelines from the National Strength and Conditioning Association (NSCA). 
 
3.4   Design and Procedure: 
Feasibility and safety single-arm registry study in subjects with newly diagnosed ductal 
carcinoma in situ (DCIS) or invasive carcinoma of the breast. 
3.5   Selection of Subjects and Sample Size: 
Women ages 20-89 treated for ductal carcinoma in situ or invasive carcinoma will be 
considered for this trial. 
The accrual goal is 43 subjects to achieve a sample size of 40 subjects, allowing for 
enrolled subjects who are unable to be complete the exercise program.   Estimated 
accrual and completion time is approximately 2 years. 
3.6   Duration of Study: 
Subjects will be on study for an approximate 15 months, with the exercise program 
encompassing 12 weeks and an assessment following 1 year after the exercise program. 
Thereafter subjects will continue to be followed by the treating medical oncologist and/or 
radiation oncologist per standard of care (SOC) for follow up care but utilizing the data for 
research purposes.  

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4.  SUBJECT ELIGIBILITY 
4.1 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 treatment for breast cancer, including one or more 
of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or 
hormonal therapy.  Women undergoing active chemotherapy or immunotherapy 
are not allowed on study. 
4 Participants must have abstained from smoking for at least 12 months  
5 Participants must be prescribed by their treating physician to engage in resistance 
training for 3 months (12 weeks). 
6 Participants will be assessed 1 year following exercises as they were at baseline 
and post exercise as SOC. 
 
4.2 Exclusion Criteria:  
1 Any current 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 deemed by PI 
to be unsafe to engage in resistance training 
 
4.3 Inclusion of Women and Minorities 
Women of all races/ethnicities will be eligible for this study and accrual is expected to 
reflect the population of subjects seen within the Pittsburgh, PA area. 
5.  EXERCISE REGIMEN 
5.1 Location:  
The exercise facility participating in the study is located within AGH Suburban at the AHN 
Cancer Institute Exercise Oncology and Resiliency Center, 100 S Jackson Ave 
Pittsburgh, PA 15202.  
5.2 Personnel: 
As per SOC, the exercise regimens will be constructed and reviewed by the Exercise 
Oncology Consortium and monitored by Colin Champ, MD, CSCS, and associated 
Certified Strength and Conditioning Specialists and staff. Champ is a radiation oncologist 
trained in integrative medicine and is a Certified Strength and Conditioning Specialist. 
Resistance training classes will be directly observed by Champ or his team of CSCS, and 

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regimens will be continually adjusted for both exercise progression and safety as per SOC 
at the facility. 
5.3 Exercise Regimen: 
The exercise regimen will utilize a mixture of compound movements utilizing both open 
and closed kinetic chain movements (CKC), focusing on exercises with the goal of 
improving body composition, strength, mobility, muscle mass, and several associated 
variables. CKC exercises are generally more intense as they require multi-joint movement 
patterns. Examples include lunges, squats, and deadlifts. Classes will be run by certified 
exercise and performance personnel and workouts will be directly observed and 
continually adjusted for both exercise progression and safety, as per SOC. It will follow a 
linear progression technique and guidelines from the National Strength and Conditioning 
Association (NSCA) will be followed. The observed classes will take place three times per 
week. Warm-up exercises focused on mobility, flexibility and core activation will be 
performed to increase mobility and reduce the risk of injury. Each individual exercise 
workout will generally progress from most intense, CKC, compound, and athletic 
movements to least intense throughout the workout to maximize safety. Additionally, each 
workout will provide full body resistance training to focus on functional exercises, intensity, 
and efficiency. Each workout will take approximately 45-60 minutes. When a participant 
has exceeded the goal number of repetitions by two for two consecutive weeks, the weight 
lifted will be increased via NSCA standards. The SOC total exercise regimen will last 3 
months. The SOC follow up assessment will occur 1 year after exercise. Data from the 
SOC exercise and assessments will be used for research.  
Exercise class attendance will be recorded. Workout regimens, including exercise type, 
sets, and repetitions will be recorded to aid in workout consistency and progression and 
to calculate load lifted. Initial strength assessment will occur during the initial two weeks 
of the workout regimen to help ascertain proper weight usage. Repetition schemes to 
mimic basic exercise principles for hypertrophy, strength, and power based on 1-repetition 
maximum (1RM) extrapolation and repetition range charts after assessing each exercise 
performed to near repetition fatigue/voluntary failure (i.e. when a repetition or safe lifting 
form can no longer be maintained while monitored by exercise physiologist). 
Weight lifted, repetitions, sets, and notes will be recorded and utilized to estimate intensity 
via volume load calculations (volume load = weight lifted × repetitions × sets). An example 
of a workout is listed below. 
 
Day One (anterior muscle closed-chain compound exercise focus): 
A1: Split Squat 4X6 week 1-4, 4X4 weeks 5-8, 4X2 week 9-12 
A2: Side plank 3X20 seconds each side week 1-6, 3X30 seconds each side week 7-12 
B1: Bird dog row 3X10 week 1-6, 3x12 week 7-12 
B2: Feet elevated glute bridge 3X10 week 1-6, 3x12 week 7-12 

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B3: Half Kneeling 1 arm overhead press 3X10 week 1-6, 3x12 week 7-12 
 
Day Two (posterior muscle closed-chain compound exercise focus): 
A1: Trap bar (or straight bar) Deadlift 4X6 week 1-4, 4X4 weeks 5-8, 4X2 week 9-12 
A2: Band pull-aparts 3X10 week 1-6, 3x12 week 7-12 
B1: Goblet squat 3X10 week 1-6, 3x12 week 7-12 
B2: Incline bench press 3X10 week 1-6, 3x12 week 7-12 
B3: Tall kneeling front raise 3X10 week 1-6, 3x12 week 7-12 
 
Day Three (strength/hypertrophy focus): 
A1: Bent over row 4X6 week 1-4, 4X4 weeks 5-8, 4X2 week 9-12 
A2: Pushups (use bar to raise up height if needed) 3X10 week 1-6, 3x12 week 7-12 
B1: Weighted hip bridge 3X10 week 1-6, 3x12 week 7-12 
B2: Step ups 3X10 week 1-6, 3x12 week 7-12 
B3: Farmers carries 3X10 steps each leg week 1-6, 3X12 steps each leg week 7-12 
6.  PATIENT ASSESSMENTS 
Table 1: Participant Assessments 
Assessment 
Screening 
Baseline 
Assessments 
(Prior to 
Program) 
During 
Exercise 
Program 
At Exercise 
Program 
Completion 
1 Year After 
Exercise 
Program 
Completion 
Consent 
X 
 
 
 
Xf 
History/Physical 
X 
 
 
 
 
Weight, height, 
and BMI 
X 
 
 
X 
X 
Body 
Composition 
Assessmenta 
 
X 
 
X 
X 
Resting 
Metabolic Rate 
Assessment 
 
X 
 
X 
X 

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QOL and 
Exercise Formsb
 
X 
 
X 
X 
Strength 
Assessmentc,d 
 
X 
X 
X 
X 
Mobility 
Assessmentc 
 
X 
 
X 
X 
Compliancee 
 
 
X 
 
 
a To calculate lean and fat mass and percentages, and total energy expenditure 
(kcal/day) SOC 
b EQ-5D-5L, and Leisure-Time Exercise Questionnaire SOC 
c Functional Mobility Survey and Y-balance test, includes grip strength SOC 
d Will also occur periodically throughout program to adjust exercise regimen SOC 
e Attendance collected at each workout 
f 
Verbally reconsent to use SOC data for research purposes 
 
6.1 Screening Assessments 
An informed consent will be signed by the patient before any study enrollment and further 
workup ensues. Subject data to be collected from the medical record including 
retrospective care data, during the screening process including a complete history and 
outcome data from treatment and disease progression, all exercise information and 
questionnaires as well as assessments. 
 
6.2 Study-Specific Assessment 
 
a. Baseline Examinations 
If not already collected during screening, baseline complete history and 
physical, weight, height, and BMI will be collected as SOC.  In addition, baseline 
QoL forms, and the Leisure-Time Exercise Questionnaire that are SOC, will be 
administered.  It will take 15-20 minutes to complete both questionnaires.  All 
baseline assessments will be performed at the Exercise Oncology Center as per 
SOC, and must be collected within the 3 months prior to starting the exercise 
regimen. No laboratory draws for this protocol are required.  
 
 
b. Baseline Metabolic, Body Composition, Strength, and Mobility Testing 
Prior to initiation of the exercise regimen, each participant will undergo body 
composition analysis via an InBody 970.  InBody testing is noninvasive and 
requires no ionizing radiation. The individual simply stands on the machine while 
holding handles. An ultrasound will also be used to measure muscle and adipose 
tissue thickness to provide additional metrics for body composition. This will be 
performed via a traditional ultrasound and software (BodyMetrix) will calculate 

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muscle mass, fat mass, and body composition metrics. More information is 
supplied in Appendix VI. Both also supply resting metablic rate calculations. 
Functional movement assessments will be performed at this visit as well, and takes 
approximately 10 minutes. 
Resting metabolic rate may also be assessed per SOC at this session via a 
VO2 Master device (VO2 Master Health Sensors Inc., British Columbia, 
Canada),where the individual will breathe into the device for several minutes at a 
time. The total test takes less than 15 minutes. The test is noninvasive and 
measures respiratory airflow and oxygen consumption in order to calculate resting 
metabolic rate. Alternatively, the InBody machine and ultrasound can be utilized to 
measure metabolic rate as well. Additional testing with this device is at the 
discretion of the staff as per SOC. Grip strength will be assessed via a Jamar Hand 
Dynamometer Grip Strength Measurement Meter bilaterally at the neutral position 
and with the arm of the head.  
These tests are part of the SOC exercise regimen and workup and no 
additional costs will be associated with these procedures.  
 
6.3 Exercise Period: 
The exercise program will last three months. The initial exercise schema was developed 
by the PI and exercise personnel. Throughout the exercise program, participants will 
continuously be assessed via load lifted calculations and observations of exercise 
mechanics, both of which will impact increases in load and exercise difficulty during the 
program, as per SOC.  
6.4 Follow-up Period: 
There will be no follow-up once an individual completes the study.  
6.5 Early Withdrawal of Subject(s): 
If at any time the constraints of this protocol are detrimental to the patient’s health and/or 
the patient no longer wishes to continue in the study, the patient will be removed from the 
protocol follow-up. In this event the reason(s) for discontinuation of study participation will 
be noted by the PI in the record. Data acquired up until that point will be retained for 
analyses. 
There will be a SOC follow up assessment 1 year after the completion of the exercise 
program. The data from the SOC assessment will be used for research purposes.  
6.5.1 Criteria for Early Withdrawal 
Subjects may voluntarily withdraw from the study at any time.  The PI may also 
discontinue a subject from the study at any time based on certain criteria. Reasons for 
PI-initiated discontinuation include: 
- 
Pregnancy 
- 
Inability to continue the exercise program 

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- 
Potential for harm to the participant 
6.5.2 Follow-up Requirements for Early Discontinuation 
There will be no follow-up once an individual completes or withdraws from the study. Data 
that was already collected from participants who discontinue will be used in analyses up 
to the point of discontinuation, and attempts will be made to collect data from participants 
at appropriate time points even after discontinuation of the exercise program. 
6.5.3 Replacement of Early Withdrawal(s) 
Subjects who prematurely withdraw will not be replaced unless withdrawal occurs prior to 
initiation of the exercise regimen. 
7.   STATISTICAL METHODS AND DATA ANALYSIS 
7.1. Analysis of Safety 
Safety will be continually assessed during each workout regimen by the exercise 
physiologist, and adjustments will be made to exercise performance during the workout 
to increase safety as per standard of care. 
 
The AEs will be reviewed and assessed by the PI and reported per AHN IRB reporting 
requirements. Accidental disclosure of confidentiality is the only adverse event that would 
occur.  
 
7.2 Analysis of Adherence 
The primary feasibility endpoint will be session attendance and will be calculated as the 
proportion of participants completing at least 75% of the planned exercise sessions. 
Dropout rate, defined as individuals who quit the workout regimen altogether, is 20%. It 
is assumed that the rate of attendance will be similar in this pilot study. The 90% lower 
confidence bound (LCB) for the proportion of patients completing at least 75% of exercise 
sessions will be constructed. A 90% LCB ≥ .56 will be considered a success (that is, the 
proportion of patients successfully completing the exercise regimen is at least 0.56 with 
90% confidence). With 40 patients studied, a 90% LCB of 0.56 is associated with a 
completion rate of 0.7. Data from all participants will be analyzed for anthropometric, 
metabolic, fitness and QOL regardless of attendance level but a subgroup analysis will 
be performed using data from participants with ≥75% attendance. 
 
7.3 Analysis of Anthropometric, Metabolic, Fitness and QOL Measurements 
 
All of the anthropometric, metabolic, fitness and QOL measurements are continuous 
variables. After assessing for normality, changes from baseline will be made using a 
paired t-test if the distribution is normal or by the Wilcoxon signed-rank test if the 
distribution is non-normal. 
 

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8.  SAFETY MONITORING AND REPORTING 
8.1 Adverse Events and Serious Adverse Events: 
Adverse events (AE) and serious adverse events (SAE) as a result of participating in the 
study are not expected because EXERT-BC is an observational study, including quality 
of life questionnaires.   
 
From the time the subject signs the informed consent form through the exercise program 
completion visit, data will be collected for all AEs and SAEs recorded in the subject’s 
medical record and adverse events case report form for summary reporting of the study’s 
objective. 
 
 
  9.  QUALITY CONTROL AND QUALITY ASSURANCE 
9.1   Monitoring: 
This clinical research study will be monitored continuously by the PI for study conduct 
and data to ensure that: 
Risk/benefit ratio is not altered to the detriment of the subjects; 
Over-accrual does not occur; 
Under-accrual is addressed with appropriate amendments or actions; 
Data are being appropriately collected in a reasonably timely manner. 
 
10.  ADMINISTRATIVE AND ETHICAL CONSIDERATIONS 
10.1 Regulatory and Ethical Compliance: 
This protocol was designed and will be conducted and reported in accordance with 
the International Conference on Harmonization (ICH) Harmonized Tripartite 
Guidelines for Good Clinical Practice, the Declaration of Helsinki, and applicable 
federal, state, and local regulations. 
 
10.2 Informed Consent: 
The informed consent form is written in a manner that is understandable to the subject 
population.  Prior to its use, the informed consent form must be approved by the IRB. 
The Principal Investigator or authorized key personnel will discuss with the potential 
subject the purpose of the research, methods, potential risks and benefits, subject 
concerns, and other study-related matters. This discussion will occur in a location that 
ensures subject privacy and in a manner that minimizes the possibility of coercion.  

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Appropriate accommodations will be made available for potential subjects who cannot 
read or understand English or are visually impaired that are first approved by the IRB.  
Potential subjects will have the opportunity to contact the Principal investigator or 
authorized key personnel with questions and will be given as much time as needed to 
make an informed decision about participation in the study. 
 
Before conducting any study-specific procedures, the Principal Investigator or 
authorized key personnel must obtain written informed consent from the subject or a 
legally acceptable representative.  The original informed consent form will be stored 
with the subject’s study records, and a copy of the informed consent form will be 
provided to the subject.  The Principal Investigator is responsible for asking the subject 
whether the subject wishes to notify his/her primary care physician about participation 
in the study.  If the subject agrees to such notification, the Principal Investigator will 
inform the subject’s primary care physician about the subject’s participation in the 
clinical study. 
 
Reconsenting of the subjects will be conducted at the time of SOC assessments. PI 
and/or study staff will inform the subjects that their 1 year follow up assessment data 
will also be used for research purposes. A note of this consenting with the subjects will 
be placed in the research record and EPIC. If subject does not consent, their follow 
up assessment data will not be used for research.  
 
10.3 Study Documentation: 
Study documentation includes but is not limited to source documents, case report 
forms (CRFs), monitoring logs, appointment schedules, study team correspondence 
with sponsors or regulatory bodies/committees, and regulatory documents that can be 
found in the AHN electronic “regulatory binder.” 
 
Source documents are original records that contain source data, which is all 
information in original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source 
documents include but are not limited to hospital records, clinical and office charts, 
laboratory notes, memoranda, evaluation checklists, and subject files.  When possible, 
the original record should be retained as the source document.  However, a photocopy 
is acceptable provided that it is a clear, legible, and an exact duplication of the original 
document. 
 
10.4 Privacy, Confidentiality, and Data Storage: 
The Principal Investigator will ensure that subject privacy and confidentiality of the 
subject’s data will be maintained.  
 
To protect privacy, every reasonable effort will be made to prevent undue access to 
subjects during the course of the study.  Prospective participants will be consented in 
an exam room where it is just the research staff, the patient and her family, if desired. 
For all future visits, interactions with research staff (study doctor and study 

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coordinators) regarding research activities will take place in a private exam room. All 
research related interactions with the participant will be conducted by qualified 
research staff who are directly involved in the conduct of the research study. 
 
To protect confidentiality, subject files in paper format will be stored in secure cabinets 
under lock and key accessible only by the research staff. Subjects will be identified 
only by a unique study number and subject initials.  Electronic records of subject data 
will be maintained using a secure password-protected database. Access to the 
database will be limited to essential study personnel. Subject data may be stored 
temporarily on encrypted and password-protected portable memory devices such as 
flash drives and external hard drives, but only when absolutely necessary.  Data stored 
on portable memory devices will be de-identified.  Subject data will be deleted from 
the portable memory device at the earliest opportunity.   
 
Upon completion of the study, research records will be archived and handled securely.     
 
Subject names or identifiers will not be used in reports, presentations at scientific 
meetings, or publications in scientific journals. 
 
Data Collection: 
The following data will be stored in the secure database: 
- Age 
- Diagnosis 
- Weight, height, and BMI 
- Comorbid medical conditions 
- Surgical procedure for breast cancer or orthopedic procedures 
- Type of hormonal therapy 
- Body composition at start/completion (body fat percentage, % fat-free mass, fat 
mass, fat-free mass, body mass) 
- Resting metabolic rate at start/completion   
- Exercise details (specific exercise, repetitions, weight, load lifted) 
- FMS and Y-balance test 
- Grip strength at start/completion   
- QOL forms (EQ-5D-5L) 
- Godin Leisure-Time Exercise Questionnaire 
- Adherence rates (percentage classes) 
- Assessments that are SOC 
 
10.5 Protocol Amendments: 
All protocol amendments must be initiated by the Principal Investigator and approved 
by the IRB prior to implementation.  IRB approval is not required for protocol changes 
that occur to protect the safety of a subject from an immediate hazard.  However, the 
Principal Investigator must inform the IRB and all other applicable regulatory agencies 
of such action immediately. 

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10.6 Records Retention: 
The Principal Investigator will maintain study-related records for the longer of a period 
of at least six years after study completion, or per AHN policy, whichever is more strict. 
 

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APPENDICES 
APPENDIX I: References 
1.  
Calle EE, Kaaks R. Overweight, obesity and cancer: epidemiological evidence 
and proposed mechanisms. Nat Rev Cancer. 2004;4(8):579-591. 
doi:10.1038/nrc1408 
2.  
Champ CE, Volek JS, Siglin J, Jin L, Simone NL. Weight Gain, Metabolic 
Syndrome, and Breast Cancer Recurrence: Are Dietary Recommendations 
Supported by the Data? Int J Breast Cancer. 2012;2012:9. 
doi:10.1155/2012/506868 
3.  
Borch KB, Braaten T, Lund E, Weiderpass E. Physical activity before and after 
breast cancer diagnosis and survival - the Norwegian women and cancer cohort 
study. BMC Cancer 2015 151. 2015;15(1):1-10. doi:10.1186/s12885-015-1971-9 
4.  
Irwin ML, McTiernan A, Bernstein L, et al. Physical activity levels among breast 
cancer survivors. Med Sci Sports Exerc. 2004;36(9):1484-1491. 
http://www.ncbi.nlm.nih.gov/pubmed/15354027. Accessed September 18, 2019. 
5.  
Champ CE, Ohri N, Klement RJ, et al. Assessing Changes in the Activity Levels of 
Breast Cancer Patients During Radiation Therapy. Clin Breast Cancer. 
2018;18(1). doi:10.1016/j.clbc.2017.08.009 
6.  
Goodwin PJ, Ennis M, Pritchard KI, et al. Fasting insulin and outcome in early-
stage breast cancer: results of a prospective cohort study. J Clin Oncol. 
2002;20(1):42-51. http://www.ncbi.nlm.nih.gov/pubmed/11773152. 
7.  
Pierce BL, Ballard-Barbash R, Bernstein L, et al. Elevated Biomarkers of 
Inflammation Are Associated With Reduced Survival Among Breast Cancer 
Patients. J Clin Oncol. 2009;27(21):3437-3444. doi:10.1200/jco.2008.18.9068 
8.  
Caan BJ, Cespedes Feliciano EM, Prado CM, et al. Association of Muscle and 
Adiposity Measured by Computed Tomography With Survival in Patients With 
Nonmetastatic Breast Cancer. JAMA Oncol. 2018;4(6):798. 
doi:10.1001/jamaoncol.2018.0137 
9.  
Poehlman ET, Dvorak R V., DeNino WF, Brochu M, Ades PA. Effects of 
Resistance Training and Endurance Training on Insulin Sensitivity in Nonobese, 
Young Women: A Controlled Randomized Trial 1. J Clin Endocrinol Metab. 
2000;85(7):2463-2468. doi:10.1210/jcem.85.7.6692 
10.  Zurlo F, Larson K, Bogardus C, Ravussin E. Skeletal muscle metabolism is a 
major determinant of resting energy expenditure. J Clin Invest. 1990;86(5):1423. 
doi:10.1172/JCI114857 
11.  
Shaibi GQ, Cruz ML, Ball GDC, et al. Effects of Resistance Training on Insulin 
Sensitivity in Overweight Latino Adolescent Males. Med Sci Sport Exerc. 
2006;38(7):1208-1215. doi:10.1249/01.mss.0000227304.88406.0f 
12.  Soares Falcetta F, de Araújo Vianna Träsel H, de Almeida FK, Rangel Ribeiro 

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Falcetta M, Falavigna M, Dornelles Rosa D. Effects of physical exercise after 
treatment of early breast cancer: systematic review and meta-analysis. Breast 
Cancer Res Treat. 2018;170(3):455-476. doi:10.1007/s10549-018-4786-y 
13.  Fogelholm M, Kukkonen-Harjula K. Does physical activity prevent weight gain--a 
systematic review. Obes Rev. 2000;1(2):95-111. 
http://www.ncbi.nlm.nih.gov/pubmed/12119991. Accessed September 18, 2019. 
14.  Weiss EP, Racette SB, Villareal DT, et al. Lower extremity muscle size and 
strength and aerobic capacity decrease with caloric restriction but not with 
exercise-induced weight loss. J Appl Physiol. 2007;102(2):634-640. 
doi:10.1152/japplphysiol.00853.2006 
15.  Westcott WL. Resistance Training is Medicine. Curr Sports Med Rep. 
2012;11(4):209-216. doi:10.1249/JSR.0b013e31825dabb8 
16.  Ligibel JA, Giobbie-Hurder A, Shockro L, et al. Randomized trial of a physical 
activity intervention in women with metastatic breast cancer. Cancer. 
2016;122(8):1169-1177. doi:10.1002/cncr.29899 
17.  Schmitz KH, Troxel AB, Dean LT, et al. Effect of Home-Based Exercise and 
Weight Loss Programs on Breast Cancer–Related Lymphedema Outcomes 
Among Overweight Breast Cancer Survivors. JAMA Oncol. August 2019. 
doi:10.1001/jamaoncol.2019.2109 
18.  Dos Santos WDN, Gentil P, de Moraes RF, et al. Chronic Effects of Resistance 
Training in Breast Cancer Survivors. Biomed Res Int. 2017;2017:8367803. 
doi:10.1155/2017/8367803 
19.  Schmitz KH, Ahmed RL, Troxel A, et al. Weight Lifting in Women with Breast-
Cancer–Related Lymphedema. N Engl J Med. 2009;361(7):664-673. 
doi:10.1056/NEJMoa0810118 
20.  Schmitz KH, Ahmed RL, Troxel AB, et al. Weight Lifting for Women at Risk for 
Breast Cancer–Related Lymphedema. JAMA. 2010;304(24):2699. 
doi:10.1001/jama.2010.1837 
21.  Ahmed RL, Thomas W, Yee D, Schmitz KH. Randomized Controlled Trial of 
Weight Training and Lymphedema in Breast Cancer Survivors. J Clin Oncol. 
2006;24(18):2765-2772. doi:10.1200/JCO.2005.03.6749 
22.  Stensdotter A-K, Hodges PW, MELLOR R, Sundelin G, Hager-Ross C. 
Quadriceps Activation in Closed and in Open Kinetic Chain Exercise. Med Sci 
Sport Exerc. 2003;35(12):2043-2047. 
doi:10.1249/01.MSS.0000099107.03704.AE 
23.  Rivera JE. Open versus Closed Kinetic Chain Rehabilitation of the Lower 
Extremity: A Functional and Biomechanical Analysis. J Sport Rehabil. 
1994;3(2):154-167. doi:10.1123/jsr.3.2.154 
24.  Schoenfeld BJ. The Mechanisms of Muscle Hypertrophy and Their Application to 
Resistance Training. J Strength Cond Res. 2010;24(10):2857-2872. 

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doi:10.1519/JSC.0b013e3181e840f3 
25.  Mathur N, Pedersen BK. Exercise as a mean to control low-grade systemic 
inflammation. Mediators Inflamm. 2008;2008:109502. doi:10.1155/2008/109502 
26.  Phillips SM. Resistance exercise: good for more than just Grandma and 
Grandpa’s muscles. Appl Physiol Nutr Metab. 2007;32(6):1198-1205. 
doi:10.1139/H07-129 
27.  Layne JE, Nelson ME. The effects of progressive resistance training on bone 
density: a review. Med Sci Sport Exerc. 1999;31(1):25-30. doi:10.1097/00005768-
199901000-00006 
28.  Müller MJ, Langemann D, Gehrke I, et al. Effect of Constitution on Mass of 
Individual Organs and Their Association with Metabolic Rate in Humans—A 
Detailed View on Allometric Scaling. Vitzthum VJ, ed. PLoS One. 
2011;6(7):e22732. doi:10.1371/journal.pone.0022732 
29.  Osterberg KL, Melby CL. Effect of acute resistance exercise on postexercise 
oxygen consumption and resting metabolic rate in young women. Int J Sport Nutr 
Exerc Metab. 2000;10(1):71-81. http://www.ncbi.nlm.nih.gov/pubmed/10939877. 
Accessed September 20, 2019. 
30.  Phillips SM, Winett RA. Uncomplicated resistance training and health-related 
outcomes: evidence for a public health mandate. Curr Sports Med Rep. 
2010;9(4):208-213. doi:10.1249/JSR.0b013e3181e7da73 
31.  Singh B, Spence RR, Steele ML, Sandler CX, Peake JM, Hayes SC. A Systematic 
Review and Meta-Analysis of the Safety, Feasibility, and Effect of Exercise in 
Women With Stage II+ Breast Cancer. Arch Phys Med Rehabil. 
2018;99(12):2621-2636. doi:10.1016/j.apmr.2018.03.026 
32.  Fairman CM, Focht BC, Lucas AR, Lustberg MB. Effects of exercise interventions 
during different treatments in breast cancer. J community Support Oncol. 
2016;14(5):200-209. doi:10.12788/jcso.0225 
33.  Myer GD, Quatman CE, Khoury J, Wall EJ, Hewett TE. Youth versus adult 
“weightlifting” injuries presenting to United States emergency rooms: accidental 
versus nonaccidental injury mechanisms. J strength Cond Res. 2009;23(7):2054-
2060. doi:10.1519/JSC.0b013e3181b86712 
34.  Hamill BP. Relative Safety of Weightlifting and Weight Training. J Strength Cond 
Res. 1994;8(1):53-57. 
35.  Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of 
fundamental movements as an assessment of function - part 1. N Am J Sports 
Phys Ther. 2006;1(2):62-72. http://www.ncbi.nlm.nih.gov/pubmed/21522216. 
Accessed October 21, 2019. 
36.  Schmidt T, Weisser B, Dürkop J, et al. Comparing Endurance and Resistance 
Training with Standard Care during Chemotherapy for Patients with Primary 
Breast Cancer. Anticancer Res. 2015;35(10):5623-5629. 

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http://www.ncbi.nlm.nih.gov/pubmed/26408735. Accessed September 15, 2019. 
37.  Champ CE, Yancy WS. Exercise and Patients With Cancer—Is It Time to Get 
Heavier With the Dose? JAMA Oncol. December 2019. 
doi:10.1001/jamaoncol.2019.5404 
38.  MAZZETTI SA, Kraemer WJ, VOLEK JS, et al. The influence of direct supervision 
of resistance training on strength performance. Med Sci Sport Exerc. 
2000;32(6):1175-1184. doi:10.1097/00005768-200006000-00023 
39.  Grimmett C, Corbett T, Brunet J, et al. Systematic review and meta-analysis of 
maintenance of physical activity behaviour change in cancer survivors. Int J 
Behav Nutr Phys Act. 2019;16(1):37. doi:10.1186/s12966-019-0787-4 
40.  Beardsley C, Contreras B. The Functional Movement Screen. Strength Cond J. 
2014;36(5):72-80. doi:10.1519/SSC.0000000000000074 
41.  Perry FT, Koehle MS. Normative data for the functional movement screen in 
middle-aged adults. J strength Cond Res. 2013;27(2):458-462. 
doi:10.1519/JSC.0b013e3182576fa6

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APPENDIX II: Quality of Life – EQ-5D-5L 

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Under each heading, please check the ONE box that best describes your health TODAY.
  
 
MOBILITY 
 
I have no problems walking 
 
I have slight problems walking 
 
I have moderate problems walking 
 
I have severe problems walking 
 
I am unable to walk 
 
SELF-CARE 
 
I have no problems washing or dressing myself 
 
I have slight problems washing or dressing myself 
 
I have moderate problems washing or dressing myself 
 
I have severe problems washing or dressing myself 
 
I am unable to wash or dress myself 
 
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities) 
 
I have no problems doing my usual activities 
 
I have slight problems doing my usual activities 
 
I have moderate problems doing my usual activities 
 
I have severe problems doing my usual activities 
 
I am unable to do my usual activities 
 
PAIN / DISCOMFORT 
 
I have no pain or discomfort 
 
I have slight pain or discomfort 
 
I have moderate pain or discomfort 
 
I have severe pain or discomfort 
 
I have extreme pain or discomfort 
 
ANXIETY / DEPRESSION 
 
I am not anxious or depressed 
 
I am slightly anxious or depressed 
 
I am moderately anxious or depressed 

I am severely anxious or depressed 
 
I am extremely anxious or depressed 
 

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10
0
20
30
40
50
60
80
70
90
100
5
15
25
35
45
55
75
65
85
95
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX III: Strength Assessment 
Strength assessment will be performed and recorded for each exercise during the initial two 
weeks of the exercise program, known as the “run-in” period, as is SOC. These numbers will be 
recorded for each participant. Loads will be calculated at three weeks and then recalculated every 
1 We would like to know how good or bad your health is TODAY. 
2 This scale is numbered from 0 to 100. 
3 100 means the best health you can imagine. 
0 means the worst health you can imagine. 
4 Mark an X on the scale to indicate how your health is TODAY. 
5 Now, please write the number you marked on the scale in the box 
below. 
YOUR HEALTH TODAY = 
The best health 
you can imagine 
 

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4 weeks until completion of the protocol. Load lifted will be calculated by multiplying the number 
or repetitions, weight per workout, and number of sets. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX IV: GODIN LEISURE-TIME EXERCISE QUESTIONNAIRE 
 

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APPENDIX V: Functional Movement Screen and Y-Balance Test 
The Functional Mobility Screen is a tool used prior to the initiation of an exercise protocol to 
assess individual mobility and movement patterns. These patterns are general accompanied by 
compensatory mechanisms that may predispose participants to injury, but can be improved 
through specific exercises which can reduce the risk of chronic injury.  
a)  STRENUOUS EXERCISE 
(HEART BEATS RAPIDLY) 
(e.g., running, jogging, hockey, football, soccer, squash, 
basketball, cross country skiing, judo, roller skating, 
vigorous swimming, vigorous long distance bicycling) 
 
 
 
X9 
b) MODERATE EXERCISE 
(NOT EXHAUSTING) 
(e.g., fast walking, baseball, tennis, easy bicycling, 
volleyball, badminton, easy swimming, alpine skiing, 
popular and folk dancing) 
 
 
 
X5 
c)  MILD/LIGHT EXERCISE 
(MINIMAL EFFORT) 
(e.g., yoga, archery, fishing from river bank, bowling, 
horseshoes, golf, snow-mobiling, easy walking) 
 
 
X3 
WEEKLY LEISURE-TIME ACTIVITY SCORE 
 
EXAMPLE 
Strenuous = 3 times/wk 
Moderate = 6 times/wk 
Light = 14 times/wk 
Total leisure activity score = (9 × 3) + (5 × 6) + (3 × 14) = 27 + 30 + 42 = 99 
 
Godin Scale Score 
Interpretation 
24 units or more 
Active 
14 – 23 units 
Moderately Active 
Less than 14 units 
Insufficiently  Active/Sedentary 
 
Adapted from: Godin, G. (2011). The Godin-Shephard leisure-time physical 
activity questionnaire. Health & Fitness Journal of Canada, 4(1), 18-22. 

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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.40 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. Normal values in the 
general population range from a score of 12.56 in individuals over the age of 65 to 14.79 in 
individuals aged 20-39, and women generally have a slightly higher score.41   
The FMS has an acceptable degree of inter-rater reliability and is currently the most well-
researched movement screen available. 
The Y-balance test has the participant stand on one leg while reaching out in 3 different directions 
with the other lower extremity. They are anterior, posteromedial and posterolateral. When using 
the Y-Balance test kit, the 3 reaches yield a “composite reach distance” or composite score used 
to predict injury.  
 
APPENDIX VI: Body Composition Testing 
All participants will undergo body composition testing via the InBody 970 model. 
InBody testing will take place at Exercise Oncology Center during initial assessment. The InBody 
test takes about 3 minutes. Participants are required to abstain from food, drink or exercise prior 
to the test and will be fasted overnight. During the exam, they merely stand quietly on the machine 
The InBody 970 is a bioimpedance analysis device, which utilizes electric currents to calculate a 
phase angle and resulting body composition metrics. Users stand barefoot on a device that is 
similar to a traditional scale, and they hold one handle for each hand, with the feet and hands 
touching metal electrodes. The device sends a low-dose electrical current and measures the 
change in phase angle. There is no risk to the user. 
An ultrasound will also be used to measure muscle and adipose tissue thickness to provide 
additional metrics for body composition. This will be performed via a traditional ultrasound and 
software (BodyMetrix) will calculate muscle mass, fat mass, and body composition metrics.