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Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial

2019-02-11Journal article Open access
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dc.contributor.authorVerdelho, Ana
dc.contributor.authorMadureira, Sofia
dc.contributor.authorCorreia, Manuel
dc.contributor.authorFerro, José Manuel
dc.contributor.authorRodrigues, Mário
dc.contributor.authorGonçalves-Pereira, Manuel
dc.contributor.authorGonçalves, Mafalda
dc.contributor.authorSantos, Ana Catarina
dc.contributor.authorVilela, Pedro
dc.contributor.authorBárrios, Helena
dc.contributor.authorBorges, Mariana
dc.contributor.authorSanta-Clara, Helena
dc.date.accessioned2020-08-27T11:02:01Z
dc.date.available2020-08-27T11:02:01Z
dc.date.issued2019-02-11
dc.description.abstractBackground: Cognitive impairment and cerebrovascular pathology are both frequent with ageing. Cognitive impairment due to vascular pathology of the brain, termed vascular cognitive impairment (VCI), is one of the most frequent causes of cognitive impairment in elderly subjects. Thus far, VCI has no specific pharmacological treatment. Recent observational studies have suggested a protective effect of physical activity in cognition, but adequate randomised controlled trials (RCT) are lacking. Methods: AFIVASC is a multi-centre randomised controlled trial, with a 6-month intervention treatment and an additional follow-up of 6 months, that aims to estimate the impact of 6 months of moderate intensity physical activity on cognition (the primary outcome) at 6 and 12 months in subjects with VCI. Participants are community dwellers with criteria for VCI without dementia or who have had previous stroke or transient ischaemic attack (TIA). Patients may be self-referred or referred from a medical appointment. After confirming the inclusion criteria, a run-in period of 1 month is conducted to access adherence; only after that are subjects randomly assigned (using a computerised program blinded to clinical details) to two groups (intervention group and best practice usual care group). The intervention consists of three physical activity sessions of 60 min each (two supervised and one unsupervised) per week. The primary outcome is measured by the presence or absence of decline in cognitive status. Secondary outcomes include changes in neuro-cognitive measures, quality of life, and functional and motor status. Primary and secondary outcomes are evaluated at 6 and 12 months by investigators blinded to both intervention and randomisation. A required sample size of 280 subjects was estimated. Statistical analyses will include regression analysis with repeated measures. The study was approved by the Ethics Committee for Health of Centro Hospitalar de Lisboa Norte (ref. no. 1063/13) and by the Ethics Committee for Health of Centro Hospitalar do Porto CHP (ref. no. 2016.055(049-DEFI/048-CES)). Discussion: We aim to show whether or not moderate physical activity has a beneficial impact on cognition, quality of life, motor, and functional status in people with vascular cognitive impairment, and to generate new insights on the applicability of implementing physical activity in this specific population.pt_PT
dc.description.sponsorshipThe authors disclose receipt of the following financial support for this research: FCT (FCT-PTDC/DTP-ES/3706/2014).pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationVerdelho A, Madureira S, Correia M, et al. Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial. Trials. 2019;20(1):114. Published 2019 Feb 11. doi:10.1186/s13063-019-3174-1pt_PT
dc.identifier.doi10.1186/s13063-019-3174-1pt_PT
dc.identifier.issn1745-6215
dc.identifier.urihttp://hdl.handle.net/10400.16/2451
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBMCpt_PT
dc.relation.publisherversionhttps://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-019-3174-1pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectCerebral small vessel diseasept_PT
dc.subjectRandomisedpt_PT
dc.subjectStrokept_PT
dc.subjectTIApt_PT
dc.subjectVascular cognitive impairmentpt_PT
dc.subjectphysical activitypt_PT
dc.titleImpact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trialpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.conferencePlaceEnglandpt_PT
oaire.citation.issue1pt_PT
oaire.citation.startPage114pt_PT
oaire.citation.titleTrialspt_PT
oaire.citation.volume20pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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