TY - JOUR
T1 - Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder
T2 - A group-randomized pilot trial
AU - De Wit, Liselotte
AU - O'Shea, Deirdre
AU - Chandler, Melanie
AU - Bhaskar, Tripti
AU - Tanner, Jared
AU - Vemuri, Prashanthi
AU - Crook, Julia
AU - Morris, Miranda
AU - Smith, Glenn
N1 - Funding Information:
The majority of the funding for this trial is provided by Florida Department of Health’s Ed and Ethel Moore Alzheimer’s Research Program (Grant Number 7AZ01).The University of Florida is paying for the costs of MRI scans in this trial. The study sponsor did not play a role in the trial design, writing of the protocol report, and the decision to submit the protocol for publication.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/10/19
Y1 - 2018/10/19
N2 - 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.
AB - 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.
KW - Behavioral interventions
KW - Cognitive training
KW - Mild cognitive impairment
KW - Neurocognitive disorder
KW - Yoga
UR - http://www.scopus.com/inward/record.url?scp=85055071864&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85055071864&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-2865-3
DO - 10.1186/s13063-018-2865-3
M3 - Article
C2 - 30340619
AN - SCOPUS:85055071864
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
IS - 1
M1 - 573
ER -