Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

Study Overview
=================
Brief 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.

Official Title
-----------------
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

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

Intervention / Treatment
-----------------
* Behavioral: Computerized brain fitness training
* Behavioral: Yoga
* Behavioral: Wellness Education
* Behavioral: Support Group (patient and partner)
* Behavioral: Cognitive Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
For the patients diagnosed with MCI: Inclusion Criteria: Written informed consent for participation. Patient also needs to sign a legally authorized representative (LAR) addendum should MCI patient become incapacitated A diagnosis of amnestic MCI (single domain or multi-domain) A Clinical Dementia Rating scale score of 0 or 0.5 At least 50. Either not taking or stable on nootropic(s) and/or pain medication for at least 3 months. Fluent in English. A score of at least 25 on the Telephone Interview for Cognitive Status for Memory. Exclusion Criteria: MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy) 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: Written informed consent for participation. At least 21 years of age. A score of at least 32 on the Telephone Interview for Cognitive Status for Memory. 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized brain fitness training<br>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<br>* 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.<br>* Other names: Brain Fitness;Behavioral: Support Group (patient and partner)<br>* 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.<br>Behavioral: Cognitive Rehabilitation<br>* 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.<br>* Other names: Memory Support System;|
| Experimental: Yoga<br>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: Yoga<br>* 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<br>Behavioral: Support Group (patient and partner)<br>* 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.<br>Behavioral: Cognitive Rehabilitation<br>* 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.<br>* Other names: Memory Support System;|
| Active Comparator: Wellness Education<br>Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group. | Behavioral: Wellness Education<br>* 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.<br>Behavioral: Support Group (patient and partner)<br>* 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.<br>Behavioral: Cognitive Rehabilitation<br>* 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.<br>* Other names: Memory Support System;|

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 |