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

Liselotte De Wit, Deirdre O'Shea, Melanie Chandler, Tripti Bhaskar, Jared Tanner, Prashanthi Vemuri, Julia Crook, Miranda Morris, Glenn Smith, Liselotte De Wit, Deirdre O'Shea, Melanie Chandler, Tripti Bhaskar, Jared Tanner, Prashanthi Vemuri, Julia Crook, Miranda Morris, Glenn Smith

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.

Keywords: Behavioral interventions; Cognitive training; Mild cognitive impairment; Neurocognitive disorder; Yoga.

Conflict of interest statement

Ethics approval and consent to participate

The University of Florida (#20170004), Mayo Clinic Jacksonville (#17-000290), and Tallahassee Memorial Healthcare (#2017-17) each have obtained approval from their Institution Review Board (IRB). Informed consent is/will be obtained by any of the authors or other investigators that are approved by the IRB of the concerning study-site. Informed consent will be obtained by going over a consent form that contains all relevant information in a private setting. Participants will be told that they can change their mind about participate and withdraw from the trial at any time without being penalized or losing benefits in any way.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart showing summary of the pilot trial design for the Physical Exercise And Cognitive Engagement Outcomes For Mild Neurocognitive Disorder (PEACEOFMND) Trial. Adapted from CONSORT Flowchart
Fig. 2
Fig. 2
Participant timeline
Fig. 3
Fig. 3
Schedule of enrolment, interventions, and assessment. Adapted from SPIRIT figure 2013

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