Abstract
BACKGROUND: Lifestyle intervention in type 2 diabetes mellitus (T2DM) is effective but needs a special local setting and is costly. Therefore, in a randomized-controlled trial we tested the hypothesis that the autonomous use of the interactive exercise game Wii Fit Plus over a period of 12 weeks improves metabolic control, with HbA1c reduction as the primary outcome, and weight loss, reduction of cardiometabolic risk factors, physical activity and quality of life (secondary outcomes) in T2DM patients. METHODS: Participants (n = 220) were randomized into an intervention and a control group. The intervention group was provided with a Wii console, a balance board and the exercise game Wii Fit Plus for 12 weeks. The control group remained under routine care and received the items 12 weeks later. At baseline and after 12 weeks (and for the control group additionally after 12 weeks of intervention) the participants' health parameters, medication, physical activity and validated questionnaires for quality of life (PAID, SF12, WHO-5, CES-D) were requested and compared in a complete case analysis using the Mann-Whitney test and the Wilcoxon signed rank test. RESULTS: 80% of participants completed the 12-week study. Patients in the intervention group significantly improved HbA1c (from 7.1 ± 1.3% to 6.8 ± 0.9%; -0.3 ± 1.1%; p = 0.0002) in comparison to the control group (from 6.8 ± 0.9% to 6.7 ± 0.7%; -0.1 ± 0.5%) and also significantly reduced fasting blood glucose (from 135.8 ± 38.9 mg/dl to 126.6 ± 36.6 mg/dl; p = 0.04), weight (from 97.6 ± 19.2 kg to 96.3 ± 18.7 kg; p < 0.001) and body mass index (from 34.1 ± 6.5 kg/m2 to 33.5 ± 6.5 kg/m2; p < 0.001). Daily physical activity increased significantly (p < 0.001). Diabetes-dependent impairment, mental health, subjective wellbeing and quality of life also improved significantly, and the number of patients with depression decreased. Similar improvements were seen in the control group after exercise game intervention. CONCLUSIONS: In this trial a low-threshold intervention with the interactive exercise game Wii Fit Plus was able to motivate T2DM patients to improve physical activity, glucometabolic control and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01735643.