Physical exercise for prevention of dementia (EPD) study: background, design and methods.
Aging population
Mild cognitive impairment
Neuropsychological test
Physical activity
Subjective memory complaints
Journal
BMC public health
ISSN: 1471-2458
Titre abrégé: BMC Public Health
Pays: England
ID NLM: 100968562
Informations de publication
Date de publication:
29 May 2019
29 May 2019
Historique:
received:
11
04
2019
accepted:
22
05
2019
entrez:
31
5
2019
pubmed:
31
5
2019
medline:
2
8
2019
Statut:
epublish
Résumé
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. 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. 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. The study is registered at ClinicalTrials.gov with the code NCT02236416 .
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
The study is registered at ClinicalTrials.gov with the code NCT02236416 .
Identifiants
pubmed: 31142290
doi: 10.1186/s12889-019-7027-3
pii: 10.1186/s12889-019-7027-3
pmc: PMC6542067
doi:
Banques de données
ClinicalTrials.gov
['NCT02236416']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Pagination
659Subventions
Organisme : Regione Molise
ID : D.D. n. 207 of 07/12/2010
Investigateurs
Giovanna Aquino
(G)
Vittorio Arcari
(V)
Lorenzo Buongusto
(L)
Giuseppina Cavallo
(G)
Mario Faraone
(M)
Nicola Ferrara
(N)
Mariella Filangieri
(M)
Melissa Fiscarelli
(M)
Sandro Iavarone
(S)
Francesca Iannetta
(F)
Stefano Moffa
(S)
Pasquale Mignogna
(P)
Giovannangelo Oriani
(G)
Federica Palombo
(F)
Tina Panichella
(T)
Silvia Pedata
(S)
Bruno Petti
(B)
Marilinda Spaziano
(M)
Maurizio Taglialatela
(M)
Roberto Valente
(R)
Références
J Clin Epidemiol. 1999 Jul;52(7):643-51
pubmed: 10391658
Int J Geriatr Psychiatry. 1999 Oct;14(10):858-65
pubmed: 10521885
Cogn Psychol. 2000 Aug;41(1):1-48
pubmed: 10945921
J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
Respir Care. 2003 Aug;48(8):783-5
pubmed: 12890299
Int Psychogeriatr. 1992 Fall;4(2):165-76
pubmed: 1477304
J Intern Med. 2004 Sep;256(3):240-6
pubmed: 15324367
J Am Geriatr Soc. 2004 Dec;52(12):2045-51
pubmed: 15571540
Neurol Sci. 2005 Jun;26(2):108-16
pubmed: 15995827
Cortex. 1977 Jun;13(2):109-18
pubmed: 16295955
Eur Psychiatry. 2008 Aug;23(5):321-30
pubmed: 18434102
Exerc Sport Sci Rev. 2008 Oct;36(4):173-8
pubmed: 18815485
Circulation. 2009 Jun 23;119(24):3144-61
pubmed: 19487589
Alzheimers Dement. 2007 Jul;3(3):186-91
pubmed: 19595937
Psychosom Med. 2010 Apr;72(3):239-52
pubmed: 20223924
J Alzheimers Dis. 2011;24(1):125-36
pubmed: 21206003
Arch Neurol. 2011 Sep;68(9):1185-90
pubmed: 21555601
Brain Struct Funct. 2012 Jan;217(1):115-25
pubmed: 21667303
Med Sci Sports Exerc. 2011 Jul;43(7):1334-59
pubmed: 21694556
Lancet Neurol. 2011 Sep;10(9):819-28
pubmed: 21775213
J Alzheimers Dis. 2012;31(3):569-80
pubmed: 22647258
Contemp Clin Trials. 2013 Jan;34(1):60-9
pubmed: 23000080
Neurology. 2012 Oct 23;79(17):1809-16
pubmed: 23019259
Lancet Neurol. 2013 Apr;12(4):357-67
pubmed: 23477989
Neurosci Biobehav Rev. 2013 Nov;37(9 Pt B):2243-57
pubmed: 23623982
Int Psychogeriatr. 2014 Jan;26(1):9-18
pubmed: 23962667
Biomed Res Int. 2014;2014:403120
pubmed: 24818140
Ageing Res Rev. 2014 Jul;16:12-31
pubmed: 24862109
Lancet Neurol. 2014 Aug;13(8):788-94
pubmed: 25030513
Dement Geriatr Cogn Disord. 2014;38(5-6):347-65
pubmed: 25171577
JAMA. 2014 Dec 17;312(23):2551-61
pubmed: 25514304
Exp Gerontol. 2015 Oct;70:105-10
pubmed: 26183691
Br J Sports Med. 2016 Dec;50(23):1443-1450
pubmed: 27095745
Int J Chron Obstruct Pulmon Dis. 2016 Apr 04;11:711-8
pubmed: 27110107
J Alzheimers Dis. 2016 Nov 1;55(1):1-18
pubmed: 27636853
Behav Brain Res. 2017 Jan 15;317:332-339
pubmed: 27702635
J Aging Phys Act. 2017 Oct 1;25(4):612-620
pubmed: 28290764
PLoS Med. 2017 Mar 21;14(3):e1002259
pubmed: 28323829
Front Aging Neurosci. 2017 May 23;9:147
pubmed: 28588474
Lancet. 2017 Dec 16;390(10113):2673-2734
pubmed: 28735855
J Am Geriatr Soc. 2018 Mar;66(3):487-495
pubmed: 29363108
BMJ. 2018 May 16;361:k1675
pubmed: 29769247
Psychol Res. 2019 Jan 9;:null
pubmed: 30627769
PLoS One. 2019 Jan 10;14(1):e0210036
pubmed: 30629631
Ital J Neurol Sci. 1987 Dec;Suppl 8:1-120
pubmed: 3330072
Exerc Sport Sci Rev. 1974;2:131-53
pubmed: 4466663
Int J Neurosci. 1984 Aug;24(1):53-61
pubmed: 6480252
Neurology. 1993 Nov;43(11):2412-4
pubmed: 8232972
Age Ageing. 1997 Jul;26(4):295-300
pubmed: 9271293
J Clin Epidemiol. 1998 Nov;51(11):903-12
pubmed: 9817107