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Introduction: Reduced bone mineral density and increased risk of falls are related with Alzheimer disease, and these increase likelihood of bone osteoporotic fractures causing serious complications such as disability, fear of falling, loss autonomy, decreased quality of life, and anticipated mortality in elderly patients. Gait and balance disturb are 2 factors to favor falls in elderly, and in patients with cognitive impairment, the risk of falls increases to double. Exercise and Mediterranean diet produce beneficial effects for aging, cognitive decline, and are widely recommended to reduce the effects of osteoporosis, fall risk, and related fragility fractures. The primary objective of this study is to evaluate the short and medium-term effects during 6 months, of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, fall risk, balance, and gait by a controlled clinical trial in patients with Alzheimer disease. Methods: The study is a 6-month, randomized controlled parallel-group, single-blinded clinical trial. Institutionalized patients with Alzheimer disease will be included. The intervention group will perform a multicomponent physical exercise program in reduced groups, with a frequency of 3 sessions per week, associated with a Mediterranean diet. This program includes strength, balance, and aerobic resistance exercises, and in the main part of the session, also ludic exercises to improve agility, coordination, and balance. The control group will receive usual care. The outcomes to assess are the change of physical functions, such as gait and balance, and the change of bone mineral density by calcaneal quantitative ultrasound, during the study follow-up at 1, 3, and 6 months. This clinical trial will generate more and new evidence on the effects of a multicomponent physical exercise program and Mediterranean diet in patients with Alzheimer disease on risk of falls and osteoporotic fractures, the relation of these with bone mineral density, gait and balance, and the correlations between them. Ethics and dissemination: This study protocol has been approved by the Ethics Committee of the University of Salamanca. The results will be published in peer-reviewed journals and disseminated in national and international conferences, to the participants and their families, and the general public through the associations of people with AD. Trial registration ID: ClínicalTrials.gov ID: NCT04439097.

We aimed to determine the short- and medium-term effects of a multimodal physical exercise program (MPEP) on bone health status, fall risk, balance, and gait in patients with Alzheimer’s disease. A single-blinded, controlled clinical trial was performed where 72 subjects were allocated in a 3:1 ratio to an intervention group (IG; n = 53) and control group (CG; n = 19), where the IG’s subjects were admitted to live in a State Reference Center of Alzheimer’s disease, which offers the targeted exercise program, while the CG’s subjects resided in independent living. A multidisciplinary health team assessed all patients before allocation, and dependent outcomes were again assessed at one, three, and six months. During the study, falls were recorded, and in all evaluations, bone mineral density was measured using a calcaneal quantitative ultrasound densitometer; balance and gait were measured using the performance-oriented mobility assessment (POMA), the timed up and go test (TUG), the one-leg balance test (OLB), and the functional reach test (FR). There were no differences between groups at baseline for all outcome measures. The prevalence of falls was significantly lower in the IG (15.09%) than in the CG (42.11%) (χ2 = 5.904; p = 0.015). We also found that there was a significant time*group interaction, with a post hoc Šidák test finding significant differences of improved physical function, especially in gait, for the IG, as assessed by POMA-Total, POMA-Gait, and TUG with a large effect size (ƞ2p = 0.185–0.201). In balance, we found significant differences between groups, regardless of time, and a medium effect size as assessed by POMA-Balance and the OLB (ƞ2p = 0.091–0.104). Clinically relevant effects were observed, although without significant differences in bone health, with a slowing of bone loss. These results show that a multimodal physical exercise program reduces fall risk and produces an improvement in gait, balance, and bone mineral density in the short and medium term in institutionalized patients with Alzheimer’s disease.

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