A multicenter, international randomised controlled design with an intervention and a control group with in total 600 heart failure patients. Patients will be randomised into attention control (control) or structured access to a Wii game computer (Wii). Patients in the control group will receive regular treatment and information about rehabilitation and daily activity. Patients will be called after 2, 4, 8, 12 weeks to discuss their daily activities. In the Wii study group patients will be introduced to the Nintendo Wii game computer in an introduction lesson and the Wii will be installed at home.
Patients will be called after 2, 4, 8, 12 weeks to discuss their activities and experiences with the Wii. A research member is available for 3 months for patients to call if there are technical problems with the Wii. After 3 months the active support ends but the patient will keep the Wii.
Main study parameters/endpoints: After 3 months we will analyze if the exercise capacity, as determined by the six-minute walking test (6MWT), improved more in the Wii group compared to the control patient. To achieve a power to detect a clinical significant difference of 30 meter in the 6MWT between control and experiment group after 3 months, based on 80% power, 5% significance, and to anticipate drop out 300 patients in both groups are needed.
We also will measure daily physical activity, health care use and quality of life. In additional we will ask patients to complete questionnaires on their motivation and self-efficacy to exercise and how they perceived their activity. We also will ask patients in the Wii group how they experienced it, if they found it practical and if there were any problems.
This study will gain insight in the effects of access and structured introduction of an easy applicable, affordable and available virtual reality serious game application.
To read more about this trial on clinicaltrials.gov click here