The Effects of strEngth aNd BaLance Exercise on Executive Function in People Living With Dementia (ENABLED): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in the Color Word Stroop Test
研究概览
简要总结
The primary aim of this study is to conduct a pilot 6-month assessor-blinded randomized controlled trial to determine if the Otago Exercise Program plus usual care improves executive function in people living with mild to moderate dementia compared to usual care among those living in a nursing home or assisted living facility. The exploratory aims are to determine if the Otago Exercise Program plus usual care improves inflammatory blood biomarkers, kynurenine metabolites, epigenetics, mobility, balance, cognition, mood, fall-related self-efficacy, health-related quality of life, sleep, physical activity, and falls by sex and race compared to usual care alone among people living with mild to moderate dementia.
详细描述
Dementia is a growing public health problem. Approximately 46.8 million individuals worldwide were living with dementia in 2015, which is estimated to reach 131.5 million by 2050. The global healthcare expenditure of dementia was $604 billion in 2010, which is projected to dramatically increase. Therefore, there is an urgent need to alleviate this growing public health concern.
Executive function is important for maintaining independence in activities of daily living; yet, people living with dementia often have poor executive function. Executive function includes the abilities to: make decisions, reason, problem-solve, initiate and maintain tasks, as well as adapt to changing cognitive conditions. Poor executive function is linked with other important health markers, such as poor physical function, falls, and mortality. It is possible that these poor health outcomes in people living with dementia may, in part, be explained by shared mechanisms including inflammation, autophagy, and apoptosis. Interestingly, these poor health outcomes among people living with dementia seem to depend on sex and race, with females and African Americans exhibiting greater comorbidities; nevertheless, the underlying mechanisms are poorly understood.
Poor executive function is linked with other important health markers, such as poor physical function and falls via reduced judgement and self-regulation. Cognitive and physical frailty are frequently observed together, likely due to common pathophysiological mechanisms. People living with dementia are often frail and prone to multiple tipping point incidents, potentially leading to adverse health outcomes. Cognitive and physical frailty also seems to depend on sex and race, with females and African Americans exhibiting a higher incidence of dementia; nevertheless, the underlying mechanisms are poorly understood. Overall, people living with dementia often have multiple comorbidities and complex medical needs; thus, research targeted at addressing these health disparities should be a frontline priority.
Exercise may be a viable strategy to improve executive function in people living with dementia. Mounting evidence suggests that strength and balance interventions (≥3x/week) are safe and effective at improving cognition and mobility, as well as reducing falls in cognitively intact community-dwelling older adults. Yet, historically, people living with dementia have been systematically excluded from intervention studies due to researchers' ineligibility criteria. Few studies have examined the influence of exercise on executive functioning among people living with dementia, but have shown no effect; it is possible that the small sample sizes may have contributed to these null findings. Therefore, further research is warranted to improve executive function and other health outcomes among people living with mild to moderate dementia.
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
- Single (Outcomes Assessor)
盲法说明
The investigators conducting the testing will be masked to group assignment.
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
- •Aged 55 years and older
- •Reside in a nursing home or assisted living facility
- •Have any type of mild to moderate dementia confirmed by medical records and/or a physician
- •Can read, write, and speak English with acceptable visual and auditory acuity
- •Able to walk 3 meters with or without the assistance of another person
- •Have a legally authorized representative who can provide informed consent
- •Able to provide assent
- •Able to understand and follow instructions
- •Have a life expectancy of ≥12 months as estimated by a healthcare provider
排除标准
- •Reside in the community
- •Severe dementia (e.g., Montreal Cognitive Assessment ≤6/30) and are not able to follow instructions
- •Severe psychiatric condition
- •Progressive neurological disease other than dementia (i.e., neurological disease, such as Parkinson's, that is mild and stable is not an exclusion)
- •Acute medical condition
- •Medical condition precluding exercise (e.g., unstable cardiac disease)
- •Recent surgery affecting mobility
- •Enrolled in another research study
- •Blindness
- •Enrolled in another research study
- •Receiving hospice care
研究组 & 干预措施
Otago Exercise Program Plus Usual Care
The Otago Exercise Program will be led by a physical therapist in a group setting (5-7 participants/exercise class). The exercise will be 20 min of walking and 30 min of strength and balance exercises 3x/week for 6 months. The physical therapist will select suitable exercises for each participant, such that the exercise is individualized and progressive. Participants will also receive usual care from health care providers (e.g., specialist and local doctor visits, community nurse visits, paid care provider visits, hospitalizations as required, and any ongoing treatment for any illness and/or their comorbidities).
干预措施: Otago Exercise Program (Other)
Usual Care Only
Usual care will consist of routine care from their health care providers (e.g., specialist and local doctor visits, community nurse visits, paid care provider visits, hospitalizations as required, and any ongoing treatment for any illness and/or their comorbidities).
结局指标
主要结局
Change in the Color Word Stroop Test
时间窗: Baseline, 6 months
Response inhibition involves deliberately suppressing dominant, automatic, or prepotent responses, and will be assessed using the Stroop Colour-Word Test. For the Stroop Test, there will be three conditions. First, participants will be asked to read aloud words printed in black ink (e.g., BLUE). Second, they were instructed to read aloud the color of colored rectangles. Finally, they will shown a page of color-words printed in incongruent colored ink (e.g., the word "BLUE" printed in red ink). Participants will be asked to name the ink color in which the words are printed (while ignoring the word itself). There will 50 trials for each condition and the time taken to read each condition will recorded.
次要结局
- Change in functional lower extremity strength (task duration (s))(Baseline, 6 months)
- Change in body composition (muscle (%))(Baseline, 6 months)
- Change in the oral Trail Making Test(Baseline, 6 months)
- Change in the Rey Auditory Verbal Learning Test(Baseline, 6 months)
- Change in the short-Falls Efficacy Scale International(Baseline, 6 months)
- Change in the Boston Naming Test(Baseline, 6 months)
- Change in the Benton Judgement of Line Orientation(Baseline, 6 months)
- Change in Health Utilities Index-3(Baseline, 6 months)
- Change in the Visual Analogue Scale(Baseline, 6 months)
- Change in body composition (fat (%))(Baseline, 6 months)
- Change in the Short Physical Performance Battery(Baseline, 6 months)
- Change in the Geriatric Depression Scale(Baseline, 6 months)
- Change in Functional Comorbidity Index(Baseline, 6 months)
- Change in body composition (weight (kg))(Baseline, 6 months)
- Change in dual-task posture (sway area (degrees/s squared))(Baseline, 6 months)
- Change in dual-task posture (root mean square sway (degrees))(Baseline, 6 months)
- Change in dual-task mobility (turn velocity (degrees/s))(Baseline, 6 months)
- Change in turning (turn velocity (degrees/s))(Baseline, 6 months)
- Change in functional lower extremity strength (lean angle (degrees))(Baseline, 6 months)
- Change in dual-task posture (jerk (m²/s^5))(Baseline, 6 months)
- Change in dual-task gait (gait speed (m/s))(Baseline, 6 months)
- Change in dual-task gait (double support (%))(Baseline, 6 months)
- Change in dual-task gait (stride length (m))(Baseline, 6 months)
- Change in dual-task gait (upper body range of motion (degrees))(Baseline, 6 months)
- Change in dual-task mobility (task duration (s))(Baseline, 6 months)
- Change in dual-task mobility (turn duration (s))(Baseline, 6 months)
- Change in dual-task mobility (lean angle (degrees))(Baseline, 6 months)
- Change in turning (task duration (s))(Baseline, 6 months)
- Change in physical activity (number of sedentary bouts)(Baseline, 6 months)
- Change in sleep efficiency (total sleep time/total time in bed)(Baseline, 6 months)
- Change in quadriceps grip strength(Baseline, 6 months)
- Change in turning (turn angle (degrees))(Baseline, 6 months)
- Change in hand grip strength(Baseline, 6 months)
- Change in physical activity (% of time in different levels of physical activity)(Baseline, 6 months)
- Change in sleep (average awake length (min))(Baseline, 6 months)
- Change in sleep (Sleep Fragmentation Index)(Baseline, 6 months)
- Change in inflammatory blood biomarkers (Interleukin-1)(Baseline, 6 months)
- Change in kynurenine pathway metabolites (tryptophan)(Baseline, 6 months)
- Change in physical activity (step count)(Baseline, 6 months)
- Change in sleep (number of awakenings)(Baseline, 6 months)
- Change in inflammatory blood biomarkers (Interleukin-6)(Baseline, 6 months)
- Change in inflammatory blood biomarkers (Tumor Necrosis Factor-α)(Baseline, 6 months)
- Change in kynurenine pathway metabolites (kynurenine)(Baseline, 6 months)
- Falls(Retrospective and Prospective for 6 months)
- Change in physical activity (time in sedentary bouts (min))(Baseline, 6 months)
- Change in kynurenine pathway metabolites (kynurenic acid)(Baseline, 6 months)
- Change in epigenetics(Baseline, 6 months)
- Change in the Digit Span Forwards and Backwards(Baseline, 6 months)
- Change in dual-task posture (frequency of sway (Hz))(Baseline, 6 months)
- Change in dual-task posture (mean velocity (m/s))(Baseline, 6 months)
- Change in dual-task posture (path length(m/s²))(Baseline, 6 months)
- Change in the Digit Symbol Substitution Test(Baseline, 6 months)
研究者
Deborah Jehu
Assistant Professor
Augusta University