Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
Not provided
Not provided
IRB Closure
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Tallahassee Memorial HealthCare | OTHER |
| Florida Department of Health | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized brain fitness training | Experimental | 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. |
|
| Yoga | Experimental | 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. |
|
| Wellness Education | Active Comparator | Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized brain fitness training | Behavioral | 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. |
| 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 |
| 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 |
| 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) |
For the patients diagnosed with MCI:
Inclusion Criteria:
Exclusion Criteria:
For the care partners:
Inclusion Criteria:
Exclusion Criteria:
1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glenn Smith, Ph. D | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30340619 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Yoga | Behavioral | 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 |
|
| Wellness Education | Behavioral | 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. |
|
| Support Group (patient and partner) | Behavioral | 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. |
|
| Cognitive Rehabilitation | Behavioral | 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. |
|
|
| 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 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015013 | Yoga |
| D012657 | Self-Help Groups |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided