Physical exercise for prevention of dementia (EPD) study: background, design and methods

Enzo Iuliano, Alessandra di Cagno, Adriana Cristofano, Antonella Angiolillo, Rita D'Aversa, Santina Ciccotelli, Graziamaria Corbi, Giovanni Fiorilli, Giuseppe Calcagno, Alfonso Di Costanzo, EPD Study Group, Giovanna Aquino, Vittorio Arcari, Lorenzo Buongusto, Giuseppina Cavallo, Mario Faraone, Nicola Ferrara, Mariella Filangieri, Melissa Fiscarelli, Sandro Iavarone, Francesca Iannetta, Stefano Moffa, Pasquale Mignogna, Giovannangelo Oriani, Federica Palombo, Tina Panichella, Silvia Pedata, Bruno Petti, Marilinda Spaziano, Maurizio Taglialatela, Roberto Valente, Enzo Iuliano, Alessandra di Cagno, Adriana Cristofano, Antonella Angiolillo, Rita D'Aversa, Santina Ciccotelli, Graziamaria Corbi, Giovanni Fiorilli, Giuseppe Calcagno, Alfonso Di Costanzo, EPD Study Group, Giovanna Aquino, Vittorio Arcari, Lorenzo Buongusto, Giuseppina Cavallo, Mario Faraone, Nicola Ferrara, Mariella Filangieri, Melissa Fiscarelli, Sandro Iavarone, Francesca Iannetta, Stefano Moffa, Pasquale Mignogna, Giovannangelo Oriani, Federica Palombo, Tina Panichella, Silvia Pedata, Bruno Petti, Marilinda Spaziano, Maurizio Taglialatela, Roberto Valente

Abstract

Background: Several observational studies have shown that exercise reduces the risk of cognitive decline; however, evidences from long-term, well-conducted, randomized controlled trials are scanty. The principal aim of this study is to verify whether a long-term program of multimodal supervised exercise improves the cognitive function and/or reduces the rate of cognitive decline in older adults at different degrees of risk for dementia.

Methods/design: EPD is a parallel group, double-blind, randomized controlled trial. Community-dwelling volunteers aged 50 years or more are being recruited from different community centers and screened for eligibility. Enrolled subjects are being divided in 3 groups: a) without subjective or objective cognitive impairment, b) with subjective memory complaints, and c) with mild cognitive impairments. Participants in each group (at least 180) are being randomly assigned (1:1) to an experimental group, performing a supervised training including aerobic and resistance exercises of moderate/high intensity, or to a control group. Primary outcome will be 48-months changes in Mini Mental State Examinations. Secondary outcomes will be changes in several cognitive tests including a composite cognitive score. Time points will be at baseline, and at 6, 12, 24, 36 and 48 months. Statistical analysis will be done as intention to treat, complete case and mixed model analysis.

Discussion: EPD is the first trial to examine the effects of a long exercise program (48 months) on cognitive performances. If successful, this trial may provide evidence for using long-term and multimodal exercise interventions for dementia prevention programs in the aging population.

Trial registration: The study is registered at ClinicalTrials.gov with the code NCT02236416 .

Keywords: Aging population; Mild cognitive impairment; Neuropsychological test; Physical activity; Subjective memory complaints.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the study

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