Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

Mild Cognitive Impairment Clinical Trial

— PEACEOFMND  

Official title:

Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03095170
• Other study ID #: IRB201700004
• Secondary ID: 7AZA19AZ15IRB201
• Status: Terminated
• Phase: N/A
• Start date: March 23, 2017
• Est. completion date: March 21, 2022

Study information

• Verified date: June 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	Florida Department of Health, Mayo Clinic, Tallahassee Memorial HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	improvement in patient memory based everyday functioning	measured by the Everyday Cognitive Functioning scale (ECOG)	baseline to 7.5 Months
Other	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
Other	improvement in patient and carepartner mood	measured by the Center for Epidemiological Studies-Depression (CESD)	baseline to 7.5 Months
Other	improvement in patient cognitive functioning	measured by the CogState	baseline to 7.5 Months
Primary	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	Diffusion Tensor Imaging (DTI)	DTI will be used to map white matter tractography in the brain.	baseline to 7.5 Months