Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Resting State Magnetic Resonance Imaging (MRI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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:
- •Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
研究组 & 干预措施
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.
干预措施: Computerized brain fitness training (Behavioral)
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.
干预措施: Support Group (patient and partner) (Behavioral)
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.
干预措施: Cognitive Rehabilitation (Behavioral)
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.
干预措施: Cognitive Rehabilitation (Behavioral)
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.
干预措施: Yoga (Behavioral)
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.
干预措施: Support Group (patient and partner) (Behavioral)
Wellness Education
Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
干预措施: Wellness Education (Behavioral)
Wellness Education
Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
干预措施: Support Group (patient and partner) (Behavioral)
Wellness Education
Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
干预措施: Cognitive Rehabilitation (Behavioral)
结局指标
主要结局
Resting State Magnetic Resonance Imaging (MRI)
时间窗: 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.
次要结局
- Diffusion Tensor Imaging (DTI)(baseline to 7.5 Months)