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Open Access 01-12-2018 | Study protocol

Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial

Published in: Trials | Issue 1/2018

Abstract

Background

Amnestic mild cognitive impairment (aMCI) is considered a risk state for the development of dementia due to Alzheimer’s disease. It is also a period in which interventions may be most effective in slowing progression to dementia. Computerized cognitive training and increased physical activity have shown to be among the most promising interventions. However, current evidence from randomized controlled trials comparing cognitive training, physical activity, and an active control is inconsistent. Furthermore, the neural mechanisms underlying these interventions are currently unclear.

Methods

The objective of the current pilot study is to explore the feasibility of a trial investigating the impact of computerized cognitive training, yoga, and an active control intervention (wellness education) in individuals with aMCI by conducting a group-randomized, multisite, parallel, three-arm pilot study. We will establish preliminary effect sizes regarding the association of each intervention with neuroimaging and cognitive and participant-reported measures. We also aim to estimate the strength of association between the various outcomes. The current trial aims to recruit 75 people with aMCI and their 75 cognitively healthy care partners through clinics and senior care facilities. The initial intervention will last 10 days and will consist of 1 h daily of the assigned intervention i.e., (yoga, computerized cognitive training, or wellness education) combined with 1 h of memory compensation training and 1 h of support groups. Twenty-five participants will be group-randomized to each arm using a random number generator. Study staff and participants will be kept blind until recruitment is complete for each group. After the initial two-week intervention, participants will continue the assigned intervention for 24 weeks. Outcome measures are: functional connectivity and cerebral perfusion as assessed by magnetic resonance imaging; cognition; daily functioning; mood; anxiety; self-efficacy; caregiver burden; quality of life; and study feasibility including recruitment and retention rates.

Discussion

This pilot trial aims to investigate the feasibility of a trial studying the impact of computerized cognitive training, yoga, and an active control intervention in persons with aMCI on MRI-based functional connectivity and cerebral perfusion as well as cognition, daily functioning, mood, anxiety, and quality of life and feasibility?

Trial registrations

ClinicalTrials.gov, NCT03095170. Registered on 23 March 2017.

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Title: Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial
Publication date: 01-12-2018
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2865-3

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial

Abstract

Background

Methods

Discussion

Trial registrations

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registrations

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