Designing studies on the effectiveness of physical training in patients with cognitive impairment.

The literature provides conflicting results on the effectiveness of physical training in cognitively impaired older individuals. Cognitive impairment has been shown to be a negative predictor of rehabilitation outcome in these persons. However, the evidence on which this discussion is based is scarce. The methodology used in previous studies shows substantial shortcomings. The presented study protocol documents the methodology of one of the largest intervention studies worldwide in this research field with a standardized specific training program in cognitively impaired subjects including short- and long-term follow-up examinations. The selected sensitive evaluation tools for motor, cognitive and emotional status have all been validated for use in older persons. Most of these tests have been validated in cognitively impaired persons. In contrast to most previously published RCTs only study participants within a comparable level of cognitive impairment will be included in the study. The primary aim of the study is to evaluate a specific training program to improve motor performance (strength and functional performance) in persons with cognitive impairment. Secondary study endpoints include the reduction of falls, improvement of cognitive as well as psychological status and the documentation of physical activity. The training program is based on previous successful intervention studies of the research group, was complemented and modified with respect to specific deficits of cognitively impaired persons and focuses on motor improvements. The article gives a rationale for interventions using physical training and study methodology in persons with dementia.