Dance Dance Revolution (DDR) in Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT00851019
• Recruitment Status: Completed
• First Posted: February 25, 2009
• Last Update Posted: March 27, 2013
• Sponsor: Charles Drew University of Medicine and Science
• Collaborator: American Diabetes Association
• Information provided by (Responsible Party): Charles Drew University of Medicine and Science

Tracking Information

• First Submitted Date: February 23, 2009
• First Posted Date: February 25, 2009
• Last Update Posted Date: March 27, 2013
• Study Start Date: February 2009
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 24, 2009): Hemoglobin A1c change from baseline [ Time Frame: 3 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 24, 2009)

• Body mass index change from baseline [ Time Frame: 3 months ]
• Body composition change from baseline [ Time Frame: 3 months ]
• Fasting lipid profile change from baseline [ Time Frame: 3 months ]
• Blood pressure change from baseline [ Time Frame: 3 months ]
• Fasting plasma glucose change from baseline [ Time Frame: 3 months ]
• HOMA-IR index change from baseline [ Time Frame: 3 months ]
• Aerobic fitness change from baseline [ Time Frame: 3 months ]
• Mean daily caloric intake [ Time Frame: 3 months ]
• Mean total exercise time [ Time Frame: 3 months ]
• Mean exercise energy expenditure [ Time Frame: 3 months ]
• Behavioral questionnaires change from baseline [ Time Frame: 3 months ]
• All adverse events [ Time Frame: 3 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dance Dance Revolution (DDR) in Type 2 Diabetes
• Official Title: Dance Dance Revolution (DDR) Exergaming in Adults With Type 2 Diabetes Mellitus
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

• Behavioral: DDR
  Ad libitum attendance to engage in "Dance Dance Revolution" (DDR) Exergaming, for a 3-month period
• Behavioral: Treadmill
  Ad libitum attendance to engage in treadmill exercise, for a 3-month period

Study Arms

• Experimental: DDR
  "Dance Dance Revolution" (DDR) Exergaming
  Intervention: Behavioral: DDR
• Active Comparator: Treadmill
  Treadmill exercise
  Intervention: Behavioral: Treadmill

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 25, 2013): 76
• Original Estimated Enrollment (submitted: February 24, 2009): 160
• Actual Study Completion Date: July 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00851019
• Other Study ID Numbers: 08-08-2177
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Charles Drew University of Medicine and Science
• Original Responsible Party: Stanley Hsia, MD, Charles Drew University of Medicine and Science
• Current Study Sponsor: Charles Drew University of Medicine and Science
• Original Study Sponsor: Same as current
• Collaborators: American Diabetes Association

Investigators

• Principal Investigator: Stanley Hsia, MD; Charles Drew University of Medicine and Science

• PRS Account: Charles Drew University of Medicine and Science
• Verification Date: March 2013