Exercise in Improving Health and Quality of Life in Breast Cancer Survivors

PRIMARY OBJECTIVES:

I. To assess the feasibility of conducting 12 week exercise intervention programs in breast
cancer survivors who are sedentary.

SECONDARY OBJECTIVES:

I. To assess the adherence rate of each of the three 12 week intervention programs by breast
cancer survivors who are sedentary.

EXPLORATORY OBJECTIVES:

I. To determine how cardiovascular fitness, body composition, nutritional choices, behavior
change, biomarkers of immune function, mitochondrial function, quality of life (QoL), and
cognitive function are affected by a 12 week physical activity program completed by sedentary
breast cancer survivors.

II. To compare differences in these outcomes among sedentary breast cancer survivors who
completed a home-based walking program versus a home-based Zumba program in a video game
format versus a supervised high intensity interval training program.

OUTLINE: Participants are randomized into 1 of 4 arms.

ARM I: Participants wear Fitbit, receive home-based DVD containing instructions to warm-up
and cool-down, and walk 10000 steps per day over 12 weeks in order to achieve the 150 minutes
per week of moderate intensity exercise. Participants also undergo resistance training by
watching the illustration video and completing 6 total blocks of 2-week per block exercise
using the Thera-BandR exercise bands.

ARM II: Participants wear Fitbit and receive a XBOX system and the video game to strive for
at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants
may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target.
Participants undergo resistance training as in Arm I.

ARM III: Participants wear Fitbit and attend supervised High Intensity Interval Training
(HIIT) exercise sessions 3 days per week over 12 weeks. Participants undergo resistance
training as in Arm I.

ARM IV: Participants wear Fitbit and continue their usual physical activity over 12 weeks.

After completion of study intervention, participants are followed up at 2 weeks.

Inclusion Criteria:

- Understand the investigational nature of this study and sign an Independent Ethics
Committee/Institutional Review Board approved written informed consent form prior to
receiving any study related procedure

- Have a previous history of invasive breast cancer who have completed treatment except
for hormonal therapy

- Do not meet the United States (U.S.) Center for Disease Control and Prevention?s
physical activity guidelines (150 minutes or 2 hours and 30 minutes a week of
moderate-intensity exercise)

Exclusion Criteria:

- Have uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

- Are pregnant or nursing

- Are unwilling or unable to follow protocol requirements

- Have any condition which in the investigator?s opinion deems the subject an unsuitable
candidate to participate in this study

- Have metastatic breast cancer

- Have orthopedic or neuromuscular disorders or arthritis that preclude participation in
exercise

- Are morbidly obese with body mass index (BMI) > 40