REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Weight change from pre- to post-intervention
研究概览
简要总结
This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.
详细描述
Primary Objective:
To evaluate changes in body weight, fitness, bi-manual dexterity, exercise motivation and self-reported eating behavior (via questionnaires) before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-EOT, in obese EC patients who will be randomized to perform 'assisted' or voluntary exercise.
Secondary Objectives:
Objective 1: To objectively examine food behavior as determined by neuronal response to high- versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states and stop/go signaling (SST) in fed states in brain regions of interest (reward and motivation circuitry) using blood oxygenation level dependent (BOLD) functional MRI before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-intervention in obese EC patients performing 'assisted' and voluntary exercise.
Objective 2: To examine the modification of the neuronal response to high vs. low calorie food images in regions of interest by polymorphisms in key genes (e.g., dopamine receptor and dopamine transporter) and serum biomarkers (e.g., leptin, BDNF) involved in regulating homeostatic and non-homeostatic energy systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Stage I endometrial adenocarcinoma (EC), grade 1 or 2, with no adjuvant chemotherapy. Patients will be eligible to enroll as soon as 3 months after completion of treatment but no later than 4 years after completion of treatment.
- •BMI ≥ 30.0 (obese)
- •Approved to be contacted by the patient's treating gynecologic oncologist
- •Meets screening criteria including successful completion of a cardiopulmonary stress test
- •Receives medical clearance from the patient's primary care physician (PCP) or gynecologic oncologist to exercise in this study
排除标准
- •Individuals unable to read and provide informed consent.
- •Women currently participating in a structured weight loss or exercise program in the past 6 months or any woman who has previously had bariatric surgery or is planning to undergo bariatric surgery in the next 12 months
- •Participants who do not consent to be in the study or who will be unavailable for follow-up assessments,
- •Pre-existing medical conditions that would be a barrier for participation in supervised exercise
结局指标
主要结局
Weight change from pre- to post-intervention
时间窗: 24 weeks after exercise intervention (EOT)
次要结局
- Change in Quality of Life (QoL)from baseline(24 weeks after exercise intervention (EOT))
- Change in Depression from baseline(24 weeks after exercise intervention (EOT))
- Change in Body Composition from baseline(at 4 weeks after exercise intervention(EOT))
- Exercise Session Adherence(24 weeks after exercise intervention (EOT))
- Change in Motivation to Exercise from baseline(24 weeks after exercise intervention (EOT))
- Change in Eating Behavior from baseline(24 weeks after exercise intervention (EOT))