Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
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About
This randomized pilot trial studies how well exercise works in improving health and quality of life in breast cancer survivors. Participating in an exercise program to maintain physical activity may help to improve health and quality of life in breast cancer survivors.
Full description
PRIMARY OBJECTIVE:
I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors.
SECONDARY OBJECTIVE:
I. To assess the adherence rate of each of the four 12-week intervention programs by breast cancer survivors in a randomized treatment arm and a patient preference arm.
OUTLINE: Participants are randomized into 1 of 5 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 attend supervised moderate intensity walking sessions weekly for 50-60 each over 12 weeks. Participants undergo resistance training as in Arm I.
ARM V: Participants wear Fitbit and continue their usual physical activity over 12 weeks.
After completion of study intervention, participants are followed up at 2 weeks and 1 month.
Enrollment
Sex
Volunteers
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 and zoledronic acid (Zometa)
- 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)
- Meets criteria for participation in low to moderate risk exercise based on the American College of Sports Medicine guideline (ACSM)
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
83 participants in 5 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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