Exploring Synergistic Effects Of Aerobic Exercise And Mindfulness Training On Cognitive Function In Older Adults: A Pilot, Proof Of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of participants who completed 70% of the assigned individual home practice exercises
研究概览
简要总结
The purpose of this study is to explore whether physical exercise, mindfulness training, or both interventions together can improve cognitive function in individuals with multiple risk factors for the development of dementia in the future.
详细描述
The investigators will test the feasibility and acceptability of a combined mindfulness training + aerobic training intervention, vs. either alone or none to improve cognitive function in older adults with cognitive impairment. The investigators will also obtain estimates of effect sizes (and confidence intervals) on cognitive function. Preliminary analyses will be conducted to explore the mediating role of changes in aerobic capacity, physical activity, vascular risk factors, and mindfulness skills. Assessments will be conducted at baseline, 3-, and 6- months since baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being physically inactive (defined as not meeting current AHA recommendations for physical activity, i.e., < 150 min of moderate-intensity aerobic activity per week OR < 75 minutes of vigorous aerobic activity per week
- •Cognitive complaint defined as answering yes to the question "do you feel that your memory or thinking skills have gotten worse recently?"
- •Fluency in English language
排除标准
- •Unwillingness/inability to provide informed consent
- •Contraindications to physical activity as per the participant's PCP assessment
- •Blood pressure >200/110
- •Severe depressive symptoms (defined as Hospital Anxiety and Depression Scale [HADS] depression subscale scores >14)
- •Acute psychosis (from medical record)
- •Severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24)
- •Recent hospitalization (< 6 weeks)
- •Current (at least once a month) mind/body practice (i.e., mindfulness meditation, yoga, or tai chi)
结局指标
主要结局
Number of participants who completed 70% of the assigned individual home practice exercises
时间窗: 3 months from baseline
The investigators will consider the study feasible under this condition
Number of participants who attended at least 70% of the planned sessions
时间窗: 3 months from baseline
The investigators will consider the study feasible under this condition
Retention rates of 80% at the final follow-up visit
时间窗: 3 months from baseline
The investigators will consider the study feasible under this condition
Acceptability will be assessed using a satisfaction survey
时间窗: 3 months from baseline
Acceptability will be assessed using a satisfaction survey. The intervention will be considered acceptable if ≥80% of participants responds that they are at least somewhat satisfied with the intervention.
次要结局
- Exploratory outcome: waist-to-hip ratio(baseline, 3, 6 months)
- An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test(baseline, 3, 6 months)
- Exploratory outcome: blood pressure(baseline, 3, 6 months)
- An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support(baseline, 3, 6 months)
- An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)(baseline, 3, 6 months)
- Effect size on cognitive function(baseline, 3, 6 months)
- An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)(baseline, 3, 6 months)
研究者
Elena Salmoirago-Blotcher
Assistant professor of Medicine
The Miriam Hospital