Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dance Dance Revolution (DDR) in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00851019
First received: February 23, 2009
Last updated: March 25, 2013
Last verified: March 2013

February 23, 2009
March 25, 2013
February 2009
July 2012   (final data collection date for primary outcome measure)
Hemoglobin A1c change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00851019 on ClinicalTrials.gov Archive Site
  • Body mass index change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body composition change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Fasting lipid profile change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood pressure change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • HOMA-IR index change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Aerobic fitness change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Mean daily caloric intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Mean total exercise time [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Mean exercise energy expenditure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Behavioral questionnaires change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Dance Dance Revolution (DDR) in Type 2 Diabetes
Dance Dance Revolution (DDR) Exergaming in Adults With Type 2 Diabetes Mellitus

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Experimental: DDR
    "Dance Dance Revolution" (DDR) Exergaming
    Intervention: Behavioral: DDR
  • Active Comparator: Treadmill
    Treadmill exercise
    Intervention: Behavioral: Treadmill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00851019
08-08-2177
Yes
Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
American Diabetes Association
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP