This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control. * Progressive combined training (PCT) will be performed in 2 phases: 1. supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom. 2. unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer. * Attention Control Group: 51 weeks home-based stretching All participants will undergo seven blood draws and participate in nine testing visits. Participation is expected to last 12 months for all participants. It is expected that about 160 people will take part in this research study. The American Cancer Society is supporting this research study by providing funding for the research study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
160
8 month exercise program with 4 month follow up.
12 month stretching program
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance
Changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA)
Time frame: 16 weeks
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Visceral adiposity
Changes from baseline in visceral adiposity (VA) measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA)
Time frame: 16 weeks
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -metabolic syndrome (MSY)
Frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA)
Time frame: 16 weeks
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups -Insulin Resistance
Compare changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) in Progressive Combine Training (PCT) and Attention (AC) groups
Time frame: 16 weeks
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - Visceral adiposity
Compare changes from baseline in Visceral adiposity (VA) measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA) in Progressive Combine Training (PCT) and Attention (AC) groups
Time frame: 16 weeks
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY)
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Compare frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY)
Time frame: 16 weeks
Metabolic Dysregulation (MetD) Status During 4 month follow up period - insulin resistance (IR)
Change in insulin resistance (IR) status from end of study PCT to 4 month follow up measured by Homeostasis Model Assessment (HOMA).
Time frame: 16 weeks
Metabolic Dysregulation (MetD) Status During 4 month follow up period - Visceral adiposity (VA)
Change in Visceral adiposity (VA) status from end of study PCT to 4 month follow up measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA).
Time frame: 16 weeks
Metabolic Dysregulation (MetD) Status During 4 month follow up period - metabolic syndrome (MSY)
Change in metabolic syndrome (MSY) frequency from end of study PCT to 4 month follow up diagnosed by criteria accepted by the American Heart Association (AHA)
Time frame: 16 weeks