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Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial (Phase II, Randomized Controlled Trial for Early Stage Breast Cancer Survivors)
This randomized phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast cancer.
PRIMARY OBJECTIVES: I. To determine the effects of a 6-month progressive combined training (PCT) program on metabolic dysregulation (MetD) in centrally obese latina breast cancer survivors (LBCS). SECONDARY OBJECTIVES: I. To determine whether improved physical fitness and health-related measures from a 6-month PCT program are associated with reductions in MetD in centrally obese LBCS. II. To determine whether MetD status and physical fitness can be maintained following a 6-month follow-up period and to establish predictors of exercise behavior in LBCS. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I (PROGRESSIVE COMBINED TRAINING \[PCT\]): Patients undergo supervised exercise sessions comprising of aerobic exercise (AE) over 30 minutes and resistance exercise (RE) over 25 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. GROUP II (PROGRESSIVE AEROBIC TRAINING \[PAT\]): Patients undergo supervised exercise sessions comprising of AE over 45-60 minutes 3 days per week for 24 weeks. Patients are encouraged to complete AE at home over 20 minutes 1 day per week. Patients receive a Polar heart rate monitor to monitor heart rate during the AE sessions. GROUP III (USUAL CARE): Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I. After completion of study, patients are followed up at 37 and 49 weeks.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Start Date
March 8, 2019
Primary Completion Date
July 31, 2019
Completion Date
July 31, 2019
Last Updated
December 17, 2020
Best Practice
OTHER
Exercise Intervention
BEHAVIORAL
Exercise Intervention
BEHAVIORAL
Laboratory Biomarker Analysis
OTHER
Monitoring Device
DEVICE
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Lead Sponsor
University of Southern California
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07379918