Evaluation of an Outdoor Mindful Walking Program for Sustaining Cognitive Function in Older African Americans at Risk for Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
The goal of this clinical trial is to understand the beneficial role of mindful walking in sustaining cognitive health in African American older adults who have elevated risk of developing neuropsychological diseases. The main question it aims to answer is "Does a multi-session mindful walking intervention lead to promising signals of sustaining cognitive health in vulnerable AA older adults?" The researchers in this 2-arm randomized controlled trial will compare the mindful walking group with a delayed mindful walking to see if the intervention efficacy is observed at multiple follow-up period.
详细描述
African American (AA) older adults in the U.S. are disproportionally impacted by ADRD compared to other races and ethnicities. Mindful walking integrates two potentially protective factors of ADRD by elevating mindfulness and physical activity (i.e., walking), resulting in a synergistic behavioral strategy that is feasible and safe for older adults. However, the efficacy of using this intervention for cognitive health outcomes has not been tested using experimental designs. This study is a community-based, mindful walking randomized controlled trial to examine its efficacy on cognitive and other health outcomes in ADRD at-risk, AA older adults. This study will recruit 114 older adults (ages 60+ years) with elevated risk of developing ADRD from the Midlands region of South Carolina. Older adults were randomly assigned to participate in 24 sessions of mindful walking or a delayed mindful walking group (n=57 in each group). The study outcomes include various key brain health determinants, including cognitive function, quality of life, psychological well-being, physical activity, mindfulness, sleep, and overall health status. Participants in both groups follow identical measurement protocol of at baseline, 12 weeks, 18 weeks, and 24 weeks. The outcome measures are administered in the lab and in everyday settings. This study will generate preliminary evidence regarding the effects of mindful walking on sustaining cognition health. It will also inform future large-scale effectiveness trials to validate our study findings. If successful, this mindful walking program can be scaled up as a low-cost and viable lifestyle strategy to promote healthy cognitive aging in diverse older adult populations, including those at greatest risk.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American ages 60 and above
- •Mild symptoms of cognitive decline or MCI
- •Physically inactive or insufficiently active (based on the 2018 US guidelines)
- •Adequate hearing and visual ability to complete study tasks and assessments
- •English proficiency
- •Medically stable with or without medication
- •Capable of providing informed consent
- •Willing to be randomized to one of the two groups
排除标准
- •Clinical diagnosis of ADRD or other brain abnormalities (e.g., strokes, epilepsy, Parkinson's disease
- •Clinical diagnosis of psychiatric disorders (i.e., depression, post-traumatic stress disorder, bipolar disorder)
- •Unable to walk independently (i.e., need caregiver's assistance) 4) Plan to have surgery or relocate outside the area within the next 6 months
- •Currently participate in other studies involving physical activity, mindfulness, or cognitive training
结局指标
主要结局
Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline, 12,18,24 weeks follow-up
MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation.
Everyday Cognition as assessed by the NIH Mobile Toolbox
时间窗: Baseline, 18, 24 weeks follow-up (4 days each), Weeks 12 and 13 (14 days)
The NIH Mobile Toolbox is a smartphone-based, ultra-brief cognitive assessments to measure different domains of cognition using the smartphone screen.
次要结局
- Subjective Physical Activity Levels as assessed by the CHAMPS (Community Health Activities Model Program for Seniors) questionnaire(Baseline, 12,18,24 weeks follow-up)
- Mobility as assessed by the 10-meter walk test(Baseline, 12,18,24 weeks follow-up)
- Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, 12,18,24 weeks follow-up)
- Perceived Stress as assessed by the Perceived Stress Scale (PSS-10)(Baseline, 12,18,24 weeks follow-up)
- Perceived Quality of Life as assessed by the EuroQol 5 dimensions and 5 levels questionnaire(Baseline, 12,18,24 weeks follow-up)
- Mindfulness Level as assessed by the Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire(Baseline, 12,18,24 weeks follow-up)
- Overall Health Status as assessed by the SF-36 self-report survey(Baseline, 12,18,24 weeks follow-up)
- Depressive Symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, 12,18,24 weeks follow-up)
- Device-based Physical Activity Levels as assessed by the activPAL Accelerometer(Weeks 12 and 13 (14 days))
研究者
Chih-Hsiang Yang
Assistant Professor
University of South Carolina