Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder (PEACEOFMND)

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.

Study Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment; Memory Disorders; Memory Impairment; Impaired Cognition; Mild Dementia; Mild Cognitive Disorder; Mild Neurocognitive Disorder; Amnestic Disorder; Dementia and Amnestic Conditions; Poor Short-term Memory
• Intervention / Treatment: Behavioral: Computerized brain fitness training; Behavioral: Support Group (patient and partner); Behavioral: Cognitive Rehabilitation; Behavioral: Yoga; Behavioral: Wellness Education

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For the patients diagnosed with MCI:

Inclusion Criteria:

1. Written informed consent for participation. Patient also needs to sign a legally authorized representative (LAR) addendum should MCI patient become incapacitated
2. A diagnosis of amnestic MCI (single domain or multi-domain)
3. A Clinical Dementia Rating scale score of 0 or 0.5
4. At least 50.
5. Either not taking or stable on nootropic(s) and/or pain medication for at least 3 months.
6. Fluent in English.
7. A score of at least 25 on the Telephone Interview for Cognitive Status for Memory.

Exclusion Criteria:

1. MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)
2. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.

For the care partners:

Inclusion Criteria:

1. Written informed consent for participation.
2. At least 21 years of age.
3. A score of at least 32 on the Telephone Interview for Cognitive Status for Memory.
4. Partner has at least twice-weekly contact with the participant.

Exclusion Criteria:

1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized brain fitness training; Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Calendar Training and Support Group. After the initial two week intervention, there will be an extended period during which participants will continue the computerized brain fitness for another 24 weeks.Participants are encouraged to do at least two hours per week.	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.; Other Names: Brain Fitness; 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.; Other Names: Memory Compensation Training; Memory Support System
Experimental: Yoga; Will receive a 10 day intervention program (over 2 weeks) consisting of Yoga, Calendar Training, and Support Group. After the initial two week intervention, there will be an extended period during which participants will continue yoga for 24 weeks. Participants assigned to the yoga intervention will continue to meet with their group and their yoga instructor for one hour per week and will be expected to do at least an additional hour of yoga by themselves every week.	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.; Other Names: Memory Compensation Training; Memory Support System; 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
Active Comparator: Wellness Education; Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.	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.; Other Names: Memory Compensation Training; Memory Support System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting State Magnetic Resonance Imaging (MRI)	Resting State MRI will allow us to investigate the functional connectivity in the brain, by looking at resting state networks such as the Default Mode Network.	baseline to 7.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusion Tensor Imaging (DTI)	DTI will be used to map white matter tractography in the brain.	baseline to 7.5 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in patient memory based everyday functioning	measured by the Everyday Cognitive Functioning scale (ECOG)	baseline to 7.5 Months
improvement in patient and care partner quality of life	measured by the quality of life measured by the Quality of Life in Alzheimer's Disease scale (QOL-AD)	baseline to 7.5 Months
improvement in patient and carepartner mood	measured by the Center for Epidemiological Studies-Depression (CESD)	baseline to 7.5 Months
improvement in patient cognitive functioning	measured by the CogState	baseline to 7.5 Months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Mayo Clinic; Florida Department of Health; Tallahassee Memorial HealthCare
• Investigators: Principal Investigator: Glenn Smith, Ph. D, University of Florida

Publications and helpful links

General Publications

• De Wit L, O'Shea D, Chandler M, Bhaskar T, Tanner J, Vemuri P, Crook J, Morris M, Smith G. Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial. Trials. 2018 Oct 19;19(1):573. doi: 10.1186/s13063-018-2865-3.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dementia; Cognitive Dysfunction; Cognition Disorders; Memory Disorders; Neurocognitive Disorders
• Other Study ID Numbers: IRB201700004; 7AZA1 (Other Grant/Funding Number: Florida Department of Health); 9AZ15 (Other Grant/Funding Number: Florida Department of Health); IRB201900522 (Other Identifier: UF (PEACEOFMND Extension)); OCR21041 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No