Nora L Nock1, Anastasia Dimitropoulos2, Stephen M Rao3, Chris A Flask4, Mark Schluchter5, Kristine M Zanotti6, Peter G Rose7, John P Kirwan8, Jay Alberts9. 1. Department of Epidemiology and Biostatistics, Case Western Reserve University, Cleveland, OH, USA; Case Comprehensive Cancer Center, Cleveland, OH, USA. Electronic address: nln@case.edu. 2. Department of Psychological Sciences, Case Western Reserve University, Cleveland, OH, USA. 3. Schey Center for Cognitive Neuroimaging, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA. 4. Case Comprehensive Cancer Center, Cleveland, OH, USA; Department of Radiology, Case Western Reserve University, Cleveland, OH, USA; Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA. 5. Department of Epidemiology and Biostatistics, Case Western Reserve University, Cleveland, OH, USA. 6. Department of Reproductive Biology, Case Western Reserve University, Cleveland, OH, USA; Gynecologic Oncology, University Hospitals Case Medical Center, Cleveland, OH, USA. 7. Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, OH, USA. 8. Department of Pathobiology, Cleveland Clinic, Cleveland, OH, USA. 9. Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, USA.
Abstract
BACKGROUND: Obesity is a leading risk factor for endometrial cancer (EC), particularly Type I forms, which are increasing in the U.S. Although death rates from most cancers have been decreasing, overall mortality in EC is increasing in the U.S. EC survivors' poor fitness combined with their surgical treatments may make weight loss particularly challenging. High intensity exercise increases neurotrophins and neurological reward via altered striatal dopamine in animals, and, in humans, chronic high intensity exercise enhances meal-induced satiety and may reduce hedonic eating. "Assisted" exercise, a mode of exercise whereby a patient's voluntary exercise rate is augmented mechanically, may modulate brain dopamine levels in Parkinson's Disease patients but has not been previously evaluated as a treatment for obesity. METHODS: We describe the rationale and design of the REWARD trial, which has the overarching goal of randomizing 120 obese EC survivors to "assisted" or voluntary rate cycling to evaluate the efficacy of "assisted" exercise in enhancing and sustaining weight loss. Patients in both arms will receive 3 days/week of supervised exercise and 1 day/week of a group dietary behavioral intervention for 16 weeks and, then, will be followed for 6 months. OUTCOMES: The primary outcome is weight loss. Secondary outcomes include measures for body composition, fitness, eating behavior, exercise motivation and, quality of life as well as cognition and food reward and motivation as assessed by functional magnetic resonance imaging (fMRI) tasks. CONCLUSIONS: If successful, the REWARD program could be extended to help sustain weight loss in obese cancer and non-cancer patients.
RCT Entities:
BACKGROUND:Obesity is a leading risk factor for endometrial cancer (EC), particularly Type I forms, which are increasing in the U.S. Although death rates from most cancers have been decreasing, overall mortality in EC is increasing in the U.S. EC survivors' poor fitness combined with their surgical treatments may make weight loss particularly challenging. High intensity exercise increases neurotrophins and neurological reward via altered striatal dopamine in animals, and, in humans, chronic high intensity exercise enhances meal-induced satiety and may reduce hedonic eating. "Assisted" exercise, a mode of exercise whereby a patient's voluntary exercise rate is augmented mechanically, may modulate brain dopamine levels in Parkinson's Diseasepatients but has not been previously evaluated as a treatment for obesity. METHODS: We describe the rationale and design of the REWARD trial, which has the overarching goal of randomizing 120 obese EC survivors to "assisted" or voluntary rate cycling to evaluate the efficacy of "assisted" exercise in enhancing and sustaining weight loss. Patients in both arms will receive 3 days/week of supervised exercise and 1 day/week of a group dietary behavioral intervention for 16 weeks and, then, will be followed for 6 months. OUTCOMES: The primary outcome is weight loss. Secondary outcomes include measures for body composition, fitness, eating behavior, exercise motivation and, quality of life as well as cognition and food reward and motivation as assessed by functional magnetic resonance imaging (fMRI) tasks. CONCLUSIONS: If successful, the REWARD program could be extended to help sustain weight loss in obese cancer and non-cancerpatients.
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