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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00532 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1B-15-6 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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PI left institution
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (PCT) | Experimental | Patients undergo supervised exercise sessions comprising of AE over 30 minutes and 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. |
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| Group II (PAT) | Experimental | 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. |
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| Group III (usual care) | Active Comparator | Patients undergo usual care. Beginning 24 weeks, patients may undergo supervised exercise sessions comprising of AE and RE as in Group I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Undergo usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in MetD | Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline. | From week 25 to week 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiorespiratory fitness | Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake. | Baseline to week 49 |
| Change in functional capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, Ph.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Exercise Intervention | Behavioral | Undergo AE |
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| Exercise Intervention | Behavioral | Undergo RE |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Monitoring Device | Device | Receive Polar heart rate monitor |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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1). Hand grip strength: Grip strength will be measured using a hand-held dynamometer on the participant's dominant hand. The subject will be asked to grip the handle of the dynamometer with one hand using as much grip pressure as possible while holding for 2 seconds; 2). Y Balance Test: All subjects will be required to complete the Y Balance by standing on a single limb and reach as far as possible with the opposite limb; 3). Modified Margaria-Kalamen Step Test will be used to test leg muscle power. Subjects will climb a flight of 10 stairs as quickly as possible, without missing a stair and will be evaluated based on time-to-completion and accuracy of completing all steps, given a total of 3 chances to complete the test as quickly as possible. |
| Baseline to week 49 |
| Change in muscle strength | The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention. | Baseline to week 49 |
| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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