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Abstract

Randomised clinical trial in order to estimate the effects of an early intersified physical activity programme

Regular physical activity enhances insulin sensitivity, improves blood glucose control, offers protection against CVD and decreases the risk of all cause mortality in the general population. However, this remains to be documented in patients with overt T2D and an inherent, more than two-fold elevated risk of dying from CVD. Notably, T2D patients are commonly obese and suffer from different conditions, such as arthrosis and heart diseases rendering it difficult to increase the level of physical activity. In Denmark, the municipalities are responsible for the population-directed preventive efforts. It would be worthwhile to take advantage of the experience of the municipalities, as they have the power and means to stimulate daily physical activity in the patients’ immediate environment. Randomising the municipalities (and not individuals) will be advantageous in the sense that the local communities are able to establish an infrastructure facilitating physical activity. Experience obtained through the so-called KRAM investigation shows that in general the local communities are eager to promote the population-directed prevention, not at least when it comes to physical activity. Forty-three of 98 municipalities volunteered for the KRAM investigation, twelve municipalities were selected. All Danish municipalities will be invited to join the physical activity study. Based on previous experience, we estimate that at least 40 % of the municipalities in Denmark will volunteer for this project, and we thereby expect to be able to include at least 5,000 T2D patients in the study over a period of two or more years. Among these, ten representative (geography, size, demography) municipalities will be selected to join “interval walking”.  In addition, all interested municipalities will be instructed in various modes to enhance the level of physical activity, including establishment of physical activity classes, internet-based education to improve individuals’ motivation to exercise; establishment of exercise paths in parks and woods, walking clubs and other similar initiatives, as well as involving various institutions within the local community in order to create a culture furthering physical activity. The remaining municipalities will serve as controls. After five years, we will investigate whether physical activity interventions lower the risk of CVD in this group. We expect that the suggested physical activity intervention is associated with a 25 percent reduction of CVD, and with an event rate of CVD of 40 % in this population, the estimated power to detect a significant beneficial effect of physical activity on CVD in 5,000 patients will be 0,80.  

Interval walking consists of 3 min. of moderate walking followed by 3 min. of walking at high speed, in total 30 min. per day. Interval walking can be monitored with a triaxial accelerometer carried on the back (Active Tracer 301, GMS, Tokyo, Japan) and a pedometer, respectively. A beeping signal alerts participants when a change of intensity is scheduled. Once participants have learned the program, they can choose the time to perform it each day. Every two weeks, the participants visit a local office, and data from the tracking devices are transferred to a central server at the administrative center through the internet for automatic analysis and reporting. The participants will receive immediate feedback and instructions on how best to achieve their individual target level. If targets are not met, the trainer will encourage the participants to increase their efforts to achieve them. Interval walking is low-tech, but highly efficient. Recent, unpublished data including 1,000 elderly Japanese individuals show that this regimen has major effects on blood pressure, body weight and blood glucose. Professor Bente Klarlund Pedersen has negotiated with the leader of the Japanese interval walking programme, Professor Hiroshi Nose, who is very interested in transferring the technology to be used in a Danish population. In this study, the continuous central registration of the physical activity level in the individual study participant allows for coupling with national registries of CVD morbidity and mortality incidence ensuring valid data and study outcomes.

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DD2 er ledet af Steno Diabetes Centrene