Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.
研究概览
简要总结
Numerous modifiable lifestyle factors have been identified that may affect the risk of older adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence suggests that interventions to reduce risk factors and enhance protective factors would be beneficial in slowing cognitive decline and decreasing the risk of incident MCI and AD. The overall objective of this pilot study, funded as a supplement to Keep Active Minnesota (KAM) (03-024; R01-AG023410) is to develop and test the feasibility of conducting a multi-domain intervention to maintain cognitive health in adults ages 60-80 with the goal of reducing the incidence of and slowing progression to MCI and other more severe forms of cognitive decline.
详细描述
The initial aim of the project was to recruit 20 cognitively intact adults ages 60-80 from one health plan, assessing them at baseline with respect to their cognitive health, multiple lifestyle factors, biomarkers and biometrics, engaging them in a 12 week lifestyle intervention and re-assessing them immediately post-intervention.
Specific Aims
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Design a multi-domain, lifestyle intervention to increase PA, social integration and cognitive stimulation, and improve nutrition in sedentary, cognitively intact adults, age 60 to 80.
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Assess the feasibility of implementing such a multi-domain intervention:
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recruit and screen 20 sedentary, cognitively intact adults aged 60 to 80 from a health plan,
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obtain baseline measures of cognitive function, physical and social activities, mood, nutrition, height and weight, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation,
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engage these adults in a 4 month pilot of this multi-domain lifestyle intervention with a phone coach and
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obtain post-intervention measures of cognitive functioning, physical and social activities, mood, nutrition, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation.
After successfully recruiting the first 20 subjects, we determined that the grant budget would allow us to enrich the study by recruiting 40 more subjects. A second, comparison arm was added. The first study arm received the intervention as described above. Subjects assigned (by chance) to the comparison arm received study materials but did not have a phone coach assigned. The additional 40 subjects were genotyped with respect to the apolipoprotein E4 (apoE4) allele.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between the ages of 60 and 80
- •Have had HealthPartners insurance for 11 out of the 12 months prior to recruitment
- •Engage in less than 90 minutes per week of moderate intensity physical activity
- •Works or volunteers 20 hours total per week or less
- •Telephone Interview for Cognitive Status (TICS) score of 31 and above
排除标准
- •Modified Charlson scores >=3 (calculated using prior year diagnoses)
- •Nonskin cancer
- •Congestive heart failure
- •Coronary heart disease
- •Psychotic Illness
- •Substance abuse
- •Terminal illness
结局指标
主要结局
We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.
时间窗: Six months after the baseline visit
次要结局
未报告次要终点