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Type 2 Diabetes MellitusNCT00851019

Dance Dance Revolution (DDR) in Type 2 Diabetes

A study testing DDR and Treadmill in people with Type 2 Diabetes Mellitus, run by Charles Drew University of Medicine and Science at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
DDR and Treadmill
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
Feb 2009to Jul 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Charles Drew University of Medicine and Science

    Los Angeles, California, 90059

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
DDR, Treadmill
Keywords
Exercise, Video game, Type 2 diabetes, Dance
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DDRBehavioural

    Ad libitum attendance to engage in "Dance Dance Revolution" (DDR) Exergaming, for a 3-month period

  • TreadmillBehavioural

    Ad libitum attendance to engage in treadmill exercise, for a 3-month period

Study groups in NCT00851019
Study groupRoleWhat they receive
DDRExperimental"Dance Dance Revolution" (DDR) Exergaming
Receives: Behavioral: DDR
TreadmillActive comparatorTreadmill exercise
Receives: Behavioral: Treadmill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1c change from baseline

    Measured: 3 months

Secondary outcomes (12)

  1. Body mass index change from baseline

    Measured: 3 months

  2. Body composition change from baseline

    Measured: 3 months

  3. Fasting lipid profile change from baseline

    Measured: 3 months

  4. Blood pressure change from baseline

    Measured: 3 months

  5. Fasting plasma glucose change from baseline

    Measured: 3 months

  6. HOMA-IR index change from baseline

    Measured: 3 months

  7. Aerobic fitness change from baseline

    Measured: 3 months

  8. Mean daily caloric intake

    Measured: 3 months

  9. Mean total exercise time

    Measured: 3 months

  10. Mean exercise energy expenditure

    Measured: 3 months

  11. Behavioral questionnaires change from baseline

    Measured: 3 months

  12. All adverse events

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00851019
Sponsor's protocol ID
08-08-2177
Status last verified
Mar 2013
First submitted
23 Feb 2009
Last updated
27 Mar 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing DDR and Treadmill in people with Type 2 Diabetes Mellitus, run by Charles Drew University of Medicine and Science at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c change from baseline (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00851019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2013.

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