Study protocol for the Alzheimer and music therapy study: An RCT to compare the efficacy of music therapy and physical activity on brain plasticity, depressive symptoms, and cognitive decline, in a population with and at risk for Alzheimer's disease.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2022
2022
Historique:
received:
13
01
2022
accepted:
13
06
2022
entrez:
30
6
2022
pubmed:
1
7
2022
medline:
6
7
2022
Statut:
epublish
Résumé
There is anecdotal evidence for beneficial effects of music therapy in patients with Alzheimer's Disease (AD). However, there is a lack of rigorous research investigating this issue. The aim of this study is to evaluate the effects of music therapy and physical activity on brain plasticity, mood, and cognition in a population with AD and at risk for AD. One-hundred and thirty-five participants with memory complaints will be recruited for a parallel, three-arm Randomized Controlled Trial (RCT). Inclusion criteria are a diagnosis of mild (early) AD or mild cognitive impairment (MCI), or memory complaints without other neuropsychiatric pathology. Participants are randomised into either a music therapy intervention (singing lessons), an active control group (physical activity) or a passive control group (no intervention) for 12 months. The primary outcomes are the brain age gap, measured via magnetic resonance imaging (MRI), and depressive symptoms. Secondary outcomes include cognitive performance, activities of daily living, brain structure (voxel-based morphometry and diffusion tensor imaging), and brain function (resting-state functional MRI). Screening of participants began in April 2018. A total of 84 participants have been recruited and started intervention, out of which 48 participants have completed 12 months of intervention and post-intervention assessment. Addressing the need for rigorous longitudinal data for the effectiveness of music therapy in people with and at risk for developing AD, this trial aims to enhance knowledge regarding cost-effective interventions with potentially high clinical applicability. ClinicalTrials.gov identifier: NCT03444181, registered on February 23, 2018.
Sections du résumé
BACKGROUND
There is anecdotal evidence for beneficial effects of music therapy in patients with Alzheimer's Disease (AD). However, there is a lack of rigorous research investigating this issue. The aim of this study is to evaluate the effects of music therapy and physical activity on brain plasticity, mood, and cognition in a population with AD and at risk for AD.
METHODS
One-hundred and thirty-five participants with memory complaints will be recruited for a parallel, three-arm Randomized Controlled Trial (RCT). Inclusion criteria are a diagnosis of mild (early) AD or mild cognitive impairment (MCI), or memory complaints without other neuropsychiatric pathology. Participants are randomised into either a music therapy intervention (singing lessons), an active control group (physical activity) or a passive control group (no intervention) for 12 months. The primary outcomes are the brain age gap, measured via magnetic resonance imaging (MRI), and depressive symptoms. Secondary outcomes include cognitive performance, activities of daily living, brain structure (voxel-based morphometry and diffusion tensor imaging), and brain function (resting-state functional MRI).
TRIAL STATUS
Screening of participants began in April 2018. A total of 84 participants have been recruited and started intervention, out of which 48 participants have completed 12 months of intervention and post-intervention assessment.
DISCUSSION
Addressing the need for rigorous longitudinal data for the effectiveness of music therapy in people with and at risk for developing AD, this trial aims to enhance knowledge regarding cost-effective interventions with potentially high clinical applicability.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03444181, registered on February 23, 2018.
Identifiants
pubmed: 35771851
doi: 10.1371/journal.pone.0270682
pii: PONE-D-22-00239
pmc: PMC9246122
doi:
Banques de données
ClinicalTrials.gov
['NCT03444181']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0270682Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Ann N Y Acad Sci. 2017 Jul;1400(1):33-45
pubmed: 28704888
Cochrane Database Syst Rev. 2018 Jul 23;7:CD003477
pubmed: 30033623
Scand J Psychol. 2010 Jun 1;51(3):237-45
pubmed: 20028488
Lancet Public Health. 2020 Jan;5(1):e62-e70
pubmed: 31910981
J Alzheimers Dis. 2017;56(3):899-916
pubmed: 28106552
Neurologia. 2017 Jun;32(5):300-308
pubmed: 26896913
Front Aging Neurosci. 2014 Apr 23;6:61
pubmed: 24795624
Neurology. 2007 Nov 6;69(19):1859-67
pubmed: 17984454
Alzheimers Dement. 2016 May;12(5):614-22
pubmed: 26988427
J Am Geriatr Soc. 1989 Sep;37(9):856-60
pubmed: 2760379
Cochrane Database Syst Rev. 2015 Mar 05;(3):CD010783
pubmed: 25740785
J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
Eur J Ageing. 2012 Jun 15;9(3):265-274
pubmed: 28804426
Alzheimers Dement. 2014 Nov;10(6):844-52
pubmed: 24798886
J Alzheimers Dis. 2021;80(1):185-195
pubmed: 33492286
J Alzheimers Dis. 2015;49(3):617-31
pubmed: 26484931
Trends Neurosci. 2011 Aug;34(8):430-42
pubmed: 21696834
J Alzheimers Dis. 2014;41(2):615-31
pubmed: 24662102
Alzheimers Dement. 2011 May;7(3):270-9
pubmed: 21514249
Alzheimer Dis Assoc Disord. 2010 Jul-Sep;24(3):284-90
pubmed: 20683186
Hum Brain Mapp. 2022 Feb 1;43(2):773-786
pubmed: 34652882
Gerontologist. 1969 Autumn;9(3):179-86
pubmed: 5349366
J Clin Neuropsychol. 1984 Nov;6(4):433-40
pubmed: 6501581
Prog Brain Res. 2015;217:237-52
pubmed: 25725918
Dement Geriatr Cogn Dis Extra. 2015 Sep 04;5(3):296-308
pubmed: 26483829
Psychopharmacol Bull. 1988;24(4):641-52
pubmed: 3249766
J Alzheimers Dis. 2014;41(2):453-66
pubmed: 24625794
PLoS One. 2013 Jun 27;8(6):e67346
pubmed: 23826273
BMC Med. 2016 Dec 22;14(1):215
pubmed: 28003033
Brain. 2011 Sep;134(Pt 9):2523-34
pubmed: 21857031
J Neurol Neurosurg Psychiatry. 2014 Apr;85(4):363-70
pubmed: 23840054
J Am Coll Health. 2017 Oct;65(7):492-501
pubmed: 28641040
J Neuropsychol. 2015 Sep;9(2):242-57
pubmed: 24894485
Int J Geriatr Psychiatry. 2010 Jul;25(7):756-63
pubmed: 19946870
Exp Aging Res. 2001 Jul-Sep;27(3):215-28
pubmed: 11441644
Annu Rev Psychol. 2005;56:89-114
pubmed: 15709930
Alzheimers Dement. 2021 Mar;17(3):327-406
pubmed: 33756057
Restor Neurol Neurosci. 2009;27(5):521-38
pubmed: 19847074
Prog Brain Res. 2015;217:37-55
pubmed: 25725909
J Altern Complement Med. 2018 Jan;24(1):33-36
pubmed: 28714736
Lancet. 2015 Jul 18;386(9990):266-73
pubmed: 25982160
Gerontologist. 2014 Aug;54(4):634-50
pubmed: 24009169
PLoS One. 2012;7(12):e52508
pubmed: 23285071
Physiol Rev. 2001 Apr;81(2):741-66
pubmed: 11274343
Alzheimers Dement (Amst). 2018 Jan 12;10:161-171
pubmed: 29552631
J Psychiatr Res. 1982-1983;17(1):37-49
pubmed: 7183759
Neuroimage. 2010 Apr 15;50(3):883-92
pubmed: 20070949
Int J Geriatr Psychiatry. 2013 Aug;28(8):781-94
pubmed: 23080214
Dement Geriatr Cogn Disord. 2009;28(1):36-46
pubmed: 19628939
BMC Geriatr. 2015 Feb 11;15:9
pubmed: 25887627
Dement Geriatr Cogn Disord. 2006;22(1):108-20
pubmed: 16717466
Annu Rev Clin Psychol. 2017 May 8;13:369-396
pubmed: 28482688
Int J Geriatr Psychiatry. 2010 Feb;25(2):111-20
pubmed: 19582756
Br J Nurs. 2010 Jan 28-Feb 10;19(2):108-13
pubmed: 20220649
Brain. 2015 Aug;138(Pt 8):2438-50
pubmed: 26041611
Neurology. 2013 Apr 2;80(14):1307-14
pubmed: 23468542
Aging Ment Health. 2018 Sep;22(9):1097-1106
pubmed: 28691506
Ageing Res Rev. 2015 Jul;22:39-57
pubmed: 25956016
Biomed Res Int. 2013;2013:752965
pubmed: 24106716
Ageing Res Rev. 2013 Mar;12(2):628-41
pubmed: 23511664
Int Psychogeriatr. 2013 May;25(5):775-84
pubmed: 23298693
BMJ Open. 2017 Mar 16;7(3):e012759
pubmed: 28302633
Alzheimers Dement. 2011 May;7(3):280-92
pubmed: 21514248