Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

Not Applicable

Terminated

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

• Registration Number: NCT03095170
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized brain fitness training	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.
Yoga	Cognitive Rehabilitation	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	Wellness Education	Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
Wellness Education	Cognitive Rehabilitation	Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
Yoga	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.
Computerized brain fitness training	Support Group (patient and partner)	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.
Computerized brain fitness training	Cognitive Rehabilitation	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	Support Group (patient and partner)	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	Support Group (patient and partner)	Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.

Primary Outcome Measures

Name	Time	Method
Resting State Magnetic Resonance Imaging (MRI)	baseline to 7.5 months	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.

Secondary Outcome Measures

Name	Time	Method
Diffusion Tensor Imaging (DTI)	baseline to 7.5 Months	DTI will be used to map white matter tractography in the brain.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States