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Open Access 01-12-2019 | Alzheimer's Disease | Study protocol

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

Authors: 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

Published in: BMC Public Health | Issue 1/2019

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.

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Title: Physical exercise for prevention of dementia (EPD) study: background, design and methods
Authors: 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
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Alzheimer's Disease
Dementia
Alzheimer's Disease
Dementia
Mild Neurocognitive Disorder
Published in: BMC Public Health / Issue 1/2019
Electronic ISSN: 1471-2458
DOI: https://doi.org/10.1186/s12889-019-7027-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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