NCT00851019已完成不适用
Dance Dance Revolution (DDR) Exergaming in Adults With Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c change from baseline
研究概览
简要总结
Regular physical activity is important for the treatment of type 2 diabetes, but it is often not sustained for many reasons, including lack of interest. New video games that involve physical movement ("exergames") may help in this regard. This study will compare the "exergame" "Dance Dance Revolution" (DDR) with traditional treadmill exercise on blood sugar control among sedentary, overweight or obese adults with type 2 diabetes.
详细描述
This study is a randomized, controlled trial of a 3-month ad libitum program of the "exergame" "Dance Dance Revolution" (DDR) versus traditional treadmill exercise. Each group of subjects will be assessed at baseline, and then assigned exclusively to one of the two exercise modalities. Subjects will be free to attend exercise sessions in their assigned exercise modality at the exercise facility, at a frequency, duration and intensity of their own choosing with minimal staff supervision, for a period of exactly 90 days; adoption of new exercise programs outside of the study will be prohibited. Dosages of any concurrent medications will be maintained constant, and all subjects will receive standardized nutrition counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 inclusive
- •Diagnosed type 2 diabetes mellitus (by ADA diagnostic criteria) for at least 1 year
- •On stable doses of oral anti-hyperglycemic medications for at least 3 months (i.e., sulfonylureas, metformin, thiazolidinediones, and/or DPP-4 inhibitors; GLP-1 analogues may also be permitted)
- •Hemoglobin A1c level between 7.5% and 9.0% inclusive
- •Body mass index (BMI) between 25.0 and 40.0 kg/m2 inclusive
- •Able to engage in a regular program of mild-to-moderate intensity physical activity
- •Subjects not currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.)
- •Able to give informed consent and cooperate with all necessary procedures of the study
排除标准
- •Any contraindications to a regular program of mild-to-moderate intensity exercise, or any cardiovascular, pulmonary, orthopedic, rheumatological or neurological conditions that may, in the opinion of the investigators, interfere with the subject's optimal participation in a regular exercise program, interfere with the quality of the data collected from the subject, or make a regular exercise program potentially hazardous
- •Diabetes mellitus currently being treated with insulin and/or pramlintide
- •Screening fasting plasma glucose (FPG) 300 mg/dL or greater or symptoms of hyperglycemia (polyuria, polydipsia); screening FPG < 60 mg dL, or a history of symptomatic hypoglycemia averaging more than once per day; or any other history suggestive of erratic glucose control
- •Screening fasting triglycerides 500 mg/dL or greater; or LDL-cholesterol 200 mg/dL or greater; screening blood pressure averaging 180 mm Hg or greater systolic or 100 mm Hg or greater diastolic
- •Subjects currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.); any such activities occurring on a sporadic basis may still disqualify the subject, depending upon its frequency, to be judged at the discretion of the PI. Subjects must maintain their usual occupational and other routine daily activities during the study at a reasonably constant level.
- •Subjects who routinely engage in DDR, either at home or video game arcades; "occasional" participation in DDR may still disqualify the subject, depending upon the frequency of participation, to be judged at the discretion of the PI
- •Changing doses of any concurrent medications that are known to alter the study's outcomes (e.g., oral anti-hyperglycemic agents, lipid-lowering agents, weight loss agents, anti-hypertensive agents, systemic glucocorticoids, thyroid medications, hormone replacement therapies, oral contraceptives, etc.) or the anticipated need to start any of these medications; such medications taken concurrently must remain at constant dosages throughout the study.
- •Past history of clinically significant dysfunction of other organ systems (e.g., known hepatic disease or hepatic transaminase levels greater than 3X the upper limit of the normal range other than steatohepatitis; known renal dysfunction or creatinine level 1.5 mg/dL or greater; past history of malignancies excluding cutaneous basal cell carcinoma; known chronic infections including HIV, endocrinopathies such as untreated thyroid disease, adrenal disease, or pituitary dysfunction, etc.), or any recent surgeries that preclude regular exercise, in the opinion of the investigators
- •Active hemolytic anemia, known hemoglobinopathies, or any other state of accelerated RBC turnover that may alter the accuracy of the HbA1c measurement
- •Pregnancy or lactation
结局指标
主要结局
Hemoglobin A1c change from baseline
时间窗: 3 months
次要结局
- Mean daily caloric intake(3 months)
- Mean total exercise time(3 months)
- Mean exercise energy expenditure(3 months)
- Behavioral questionnaires change from baseline(3 months)
- All adverse events(3 months)
- Body mass index change from baseline(3 months)
- Body composition change from baseline(3 months)
- Fasting lipid profile change from baseline(3 months)
- Blood pressure change from baseline(3 months)
- Fasting plasma glucose change from baseline(3 months)
- HOMA-IR index change from baseline(3 months)
- Aerobic fitness change from baseline(3 months)
研究者
研究点 (2)
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