EXERT-BCHC: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Muscle and Fat Mass
Study Overview
Brief Summary
This study investigates the impact of four standard of care, monitored group exercise regimens (resistance training) on conditioning and hypertrophy in women previously treated for breast cancer. The study will compare two conditioning regimens (6-12-25 and 8x8) and two hypertrophy regimens (5/5/5 cluster sets and double training) to assess changes in VO2 max, muscle mass, and fat mass.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 89 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 20-89 years
- •Women prescribed exercise as a Standard of Care
- •Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
- •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 are not allowed on study. Immunotherapy or targeted agent usage is allowed.
- •Women with > 6 months of resistance training experience under expert guidance by a CSCS
Exclusion Criteria
- •Any current treatment with cytotoxic chemotherapy for breast cancer
- •Inability to safely engage in group sessions of resistance training as deemed by study Pl
- •Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by Pl to be unsafe to engage in resistance training
- •Beta blocker or GLP-1 inhibitor medications
- •Pregnant women
Outcomes
Primary Outcomes
Change in Muscle and Fat Mass
Time Frame: Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.
Change in muscle mass and fat mass in pounds as measured by InBody 970.
Change in VO2 max
Time Frame: Measured monthly during the 5-month exercise program at weeks 4, 8, 12, 16, and 20.
Change in maximal oxygen consumption (VO2 max) measured during and after each exercise regimen.
Secondary Outcomes
- Change in Hand Grip Strength(Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.)
- Change in Psychology Questionnaire Scores(Baseline, at the completion of the 5-month exercise program (Week 20), and monthly during the exercise program at weeks 4, 8, 12, and 16.)
Investigators
Colin Champ, MD
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)