Efficacy of simultaneous aerobic exercise and cognitive training in subjective cognitive decline: study protocol for randomized controlled trial of the Exergames Study.
Aerobic exercise
Alzheimer’s disease
Cognition
Cognitive training
Exercise
Subjective cognitive decline
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Jan 2021
06 Jan 2021
Historique:
received:
22
06
2020
accepted:
07
12
2020
entrez:
7
1
2021
pubmed:
8
1
2021
medline:
22
6
2021
Statut:
epublish
Résumé
Subjective cognitive decline (SCD) is an early manifestation of Alzheimer's disease (AD) and offers a therapeutic window where interventions have strong potential to prevent or delay the progression of AD. Aerobic exercise and cognitive training represent two promising interventions for AD prevention, but their synergistic effect has yet to be assessed in persons with SCD. The purpose of this single-blinded, 3-parallel group randomized controlled trial is to test the synergistic efficacy of an exergame intervention (simultaneous moderate-intensity aerobic cycling and cognitive training) on cognition and aerobic fitness in community-dwelling older adults with SCD. The Exergames Study will randomize 96 participants on a 2:1:1 allocation ratio to 3-month exergame, cycling only, or attention control (stretching). Primary outcomes include global cognition and aerobic fitness, which will be assessed at baseline and after 3 months. The specific aims of the Exergames Study are to (1) determine the efficacy of the exergame in older adults with SCD and (2) assess the distraction effect of exergame on aerobic fitness. Data will be analyzed using ANOVA following intention-to-treat. This study will test the synergistic effects of exergame on cognition and aerobic fitness. It has the potential to advance prevention research for AD by providing effect-size estimates for future trials. ClinicalTrials.gov NCT04311736 . Registered on 17 March 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Subjective cognitive decline (SCD) is an early manifestation of Alzheimer's disease (AD) and offers a therapeutic window where interventions have strong potential to prevent or delay the progression of AD. Aerobic exercise and cognitive training represent two promising interventions for AD prevention, but their synergistic effect has yet to be assessed in persons with SCD.
METHODS/DESIGN
METHODS
The purpose of this single-blinded, 3-parallel group randomized controlled trial is to test the synergistic efficacy of an exergame intervention (simultaneous moderate-intensity aerobic cycling and cognitive training) on cognition and aerobic fitness in community-dwelling older adults with SCD. The Exergames Study will randomize 96 participants on a 2:1:1 allocation ratio to 3-month exergame, cycling only, or attention control (stretching). Primary outcomes include global cognition and aerobic fitness, which will be assessed at baseline and after 3 months. The specific aims of the Exergames Study are to (1) determine the efficacy of the exergame in older adults with SCD and (2) assess the distraction effect of exergame on aerobic fitness. Data will be analyzed using ANOVA following intention-to-treat.
DISCUSSION
CONCLUSIONS
This study will test the synergistic effects of exergame on cognition and aerobic fitness. It has the potential to advance prevention research for AD by providing effect-size estimates for future trials.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT04311736 . Registered on 17 March 2020.
Identifiants
pubmed: 33407727
doi: 10.1186/s13063-020-04950-7
pii: 10.1186/s13063-020-04950-7
pmc: PMC7788690
doi:
Banques de données
ClinicalTrials.gov
['NCT04311736']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
14Subventions
Organisme : NIA NIH HHS
ID : 4R44AG055176-02
Pays : United States
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