Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

NCT03095170 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-07-06

No results posted yet for this study

Summary

Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.

Conditions

  • Mild Cognitive Impairment
  • Memory Disorders
  • Mild Dementia
  • Impaired Cognition
  • Mild Cognitive Disorder
  • Amnestic Disorder
  • Dementia and Amnestic Conditions
  • Poor Short-term Memory
  • Memory Impairment
  • Mild Neurocognitive Disorder

Interventions

BEHAVIORAL

Computerized brain fitness training

Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program.

BEHAVIORAL

Yoga

Will use adapted Hatha Yoga where participants sit on armless chairs placed on sticky mats for some asana (poses) and use the chair for support throughout. This adapted Hatha Yoga style is appropriate for older adults including those who have limited mobility, use walkers or are in wheelchairs. The appropriately sequenced yoga practice meets the American College of Sports Medicine recommendation for older adults for muscle strengthening and flexibility. Instructions are modeled for the participants

BEHAVIORAL

Wellness Education

The education component will involve daily 60-minute group sessions with topics such as Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.

BEHAVIORAL

Support Group (patient and partner)

Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.

BEHAVIORAL

Cognitive Rehabilitation

Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here. Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER
  • Tallahassee Memorial HealthCare

    collaborator OTHER
  • Florida Department of Health

    collaborator OTHER_GOV
  • University of Florida

    lead OTHER

Principal Investigators

  • Glenn Smith, Ph. D · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095170 on ClinicalTrials.gov