Evaluation of the effect of structured exercise therapy on neurophysiological and cognitive functions of young adults with type 2 diabetes mellitus: Study protocol

Background: This randomized controlled trial (RCT) aims to evaluate the effect of structured exercise therapy on different mentioned neurophysiological and cognitive functions of patients diagnosed with type 2 diabetes mellitus (T2DM). It is well known from the literature that neurophysiological and cognitive disturbances are of the complications of diabetes mellitus. Although studies have shown that exercise enhances cognitive abilities in normal individuals, previous studies that have found improvement in cognitive dysfunctions in older T2DM patients with exercise regimens were not conclusive. The earlier studies were limited to a single measure of cognitive function or short follow-up times; also there is almost no evidence of the effect of exercise on cognitive function in young adult T2DM patients. Methods/Design: This is an RCT that has enrolled a total of 146 patients with T2DM divided equally into a diabetic group and an interventional group. Seventy-three sex-, age-, and mean education level-matched subjects have been enrolled as healthy controls, comparing mentioned parameters evaluating neurophysiological and cognitive functions. The intervention therapy will be delivered at the Physiology Research Laboratory as an individually designed program of regular exercise consisting of aerobic and resistance exercises. Discussion: The results of this trial will provide novel data to indicate whether exercise improves cognition for a vulnerable group of young adults, and will set the stage for larger trials to further examine potential protective and disease-modifying effects of exercise on the brain. Ethical Clearance No: Ref. No.KLEU/Ethic/2012-13/D-457