Maintaining Independence in Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in dementia-related behaviors (participant)
研究概览
简要总结
The primary goal of this study is to perform a 36-week pilot study with a cross-over design to study the safety and efficacy of a novel integrative exercise program called PLIÉ (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and Western exercise traditions and is specifically designed to target the muscles and movements needed to help individuals with mild-to-moderate dementia maintain physical function and independence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Participant:
- •Current participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
- •Recommended by Swindells staff
- •mild-to-moderate dementia
- •caregiver consent
- •Inclusion Criteria - Caregiver:
- •Provide care to primary participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
- •can provide information about the primary participant's physical functioning, behaviors, falls, quality of life and own level of stress.
排除标准
- •Primary Participant:
- •major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
- •life expectancy < 1 year (e.g., metastatic cancer)
- •inability to assent to study procedures
- •Exclusion Criteria - Caregiver:
- •Any major neurologic disease (e.g., dementia, stroke, Parkinson's disease, ALS)
- •major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
- •life expectancy < 1 year (e.g., metastatic cancer)
- •evidence of cognitive impairment
- •inability to consent to study procedures.
研究组 & 干预措施
Group 1
PLIÉ exercise program 30-45 minutes, 2-3 days/week for 18 weeks followed by 18 weeks of usual care (20-minutes of chair-based exercises 2-5 days/week).
干预措施: PLIÉ (Preventing Loss of Independence through Exercise) (Behavioral)
Group 2
Usual care (20 minutes of chair-based exercises 2-5 days/week) for 18 weeks followed by the PLIÉ exercise program 30-45 minutes/day, 2-3 days/week for 18 weeks.
干预措施: PLIÉ (Preventing Loss of Independence through Exercise) (Behavioral)
结局指标
主要结局
Change in dementia-related behaviors (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Participant's dementia-related behaviors will be assessed with the Neuropsychiatric Inventory (NPI), which is a 144-point informant-based questionnaire that assesses 12 behavioral domains common in dementia including frequency, severity and impact on caregiver distress (Cummings 1997).
Change in number of falls (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Participant's falls will be assessed based on caregiver report.
Compliance (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks.
Change in fall-related self-efficacy (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Fall-related self-efficacy will be assessed with the Falls Efficacy Scale (FES), which is a 10-item scale that has been validated in individuals with cognitive impairment (Hauer 2010).
Change in cognitive function (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Cognitive function will be assessed with the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) (Rosen 1984), which is the most commonly used primary outcome measure in AD treatment trials. It is an 80-point scale that includes direct assessment of learning (word list), naming (objects), following commands, constructional Praxis (figure copying), ideational Praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions.
Change in functional health and well-being (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Functional health and well-being will be assessed with the SF-36v2, which assesses function in eight domains and provides physical and mental component summary scores that may range from 0 to 70 (Stewart 1989). The SF-36v2 is typically administered directly to participants. However, we also will ask caregivers to answer questions on behalf of participants and will compare their answers to assess congruence. Data collected will help to determine if this measure is suitable for a larger trial.
Change in physical function (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Participant's physical function will be assessed with the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale (Galasko 1997). The ADCS-ADL is a 78-point scale that assesses functional ability in 23 daily activities based on informant report. It is the standard measure for assessment of functional status in AD treatment trials.
Change in quality of life (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Quality of life will be assessed with the Quality of Life Scale in Alzheimer's Disease (QOL-AD), which is a brief, 13-item measure that obtains input from both the individual and the caregiver (Logsdon 1999). Scores may range from 13-52 points.
Change in physical performance (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Physical performance will be assessed with the Short Physical Performance Battery (SPPB), which was developed by the National Institute on Aging to provide an objective tool for evaluating lower extremity functioning in older adults. The test includes repeated chair stands, tandem balance testing and 8' walking speed (Guralnik 1994).
Adverse events (participant)
时间窗: Baseline, 18 weeks, 36 weeks
Number of adverse events from baseline to 18 weeks and from 18 weeks to 36 weeks will be monitored through biweekly telephone calls with caregivers.
次要结局
- Change in burden (caregiver)(Baseline, 18 weeks, 36 weeks)
- Change in functional health and well-being (caregiver)(Baseline, 18 weeks, 36 weeks)
研究者
Deborah Barnes
Associate Professor, Psychiatry and Epidemiology & Biostatistics
University of California, San Francisco