Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 6
- 主要终点
- Change in participants' body mass index at each time frame from baseline
研究概览
简要总结
This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.
详细描述
This study will conduct a pragmatic group-randomized trial (GRT) with NHPIs aged 50-75 years with at least 1 of 4 modifiable vascular risk factors for ADRD (hypertension, hyperglycemia, obesity, or dyslipidemia) and either SCI or MCI using a wait-list control design to test the effects of the hula-based intervention. The primary outcomes will be vascular risk factors for ADRD and subjective cognitive complaints. Secondary outcomes will include measures of cognitive performance, physical function, and mental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-reported Native Hawaiian or other Pacific Islander ancestry;
- •ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age);
- •has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI);
- •have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2);
- •physically able and willing to engage in moderate physical activity necessary for Hula; and
- •physician's approval to participate in moderate physical activity
排除标准
- •currently pregnant;
- •already actively practicing Hula at least once per week; or
- •clinical diagnosis of ADRD (mild to severe); or
- •current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the Center for Epidemiological Studies Depression Scale (CES-D).
结局指标
主要结局
Change in participants' body mass index at each time frame from baseline
时间窗: 3 months, 8 months, 12 months
Vascular risk factor assessed using Tanita BWB800AS scale
Change in participants' overall Cognivue score at each time frame from baseline
时间窗: 3 months, 8 months, 12 months
Cognitive function assessed using Cognivue device
Change in participants' Hemoglobin A1c at each time frame from baseline
时间窗: 12 months
Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' total cholesterol at each time frame from baseline
时间窗: 3 months, 8 months, 12 months
Vascular risk factor assessed using Alere Cholestech LDX® System
Change in participants' Cognitive Change Index score at each time frame from baseline
时间窗: 3 months, 8 months, 12 months
Cognitive function assessed using Cognitive Change Index assessment
Change in participants' Number Symbol Coding Test score at each time frame from baseline
时间窗: 3 months, 8 months, 12 months
Cognitive function assessed using Number Symbol Coding Test
Change in participants' systolic blood pressure at each time frame from baseline
时间窗: 3 months, 8 months, 12 months
Vascular risk factor assessed using Omron©HEM-907XL
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline
时间窗: 3 months, 8 months, 12 months
Cognitive function assessed using Quick Dementia Rating System assessment
次要结局
未报告次要终点