Paired Integrative Exercise Program for People With Dementia and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Life (Affected Individual, Self-report)
研究概览
简要总结
Preventing Loss of Independence through Exercise (PLIÉ) is a unique, multimodal movement program for people with dementia (affected individuals) that is taught by trained instructors and combines physical, mental and social activities. The Paired PLIÉ Program is an adapted version designed for pairs of affected individuals and care partners. The goal of this study is to perform a randomized, controlled trial (RCT) with a delayed start design to examine the effects of the Paired PLIÉ Program on function and quality of life in affected individuals and care partners.
详细描述
Study participants are 30 pairs of individuals with mild-to-moderate dementia and their primary care partners (N=60 total) who are randomly assigned to Group 1 (immediate start) or Group 2 (delayed start). Pairs randomized to Group 1 participate together in the Paired PLIÉ program 2 days/week for 12 weeks (24 classes total) while pairs randomized to Group 2 continue with their usual activities. Then Group 1 transitions into a maintenance phase, and Group 2 participates in the Paired PLIÉ program 2 days/week for 12 weeks. Outcome data are collected in all study participants at baseline, mid-point and end-point so that we can examine the initial impact of the program as well as whether effects are maintained in Group 1. Outcome measures include cognitive function, physical performance, quality of life and caregiver well-being.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person with Cognitive Impairment
- •diagnosis of cognitive impairment or dementia
- •mild to moderate severity, defined as Clinical Dementia Rating of 0.5, 1 or 2
- •willing and able to engage in study procedures
- •English language fluency
- •Inclusion Criteria: Care Partner
- •provide care for person with cognitive impairment
- •willing and able to engage in study procedures
- •English language fluency
排除标准
- •Person with cognitive impairment
- •planning to miss more than 2 weeks during the study period
- •behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues)
- •unable to take 2 steps independently without cane or walker
- •terminal illness (life expectancy < 1 year)
- •currently participating in another research study that could impact current study
- •changes to dementia medications 3 months prior to baseline or changes planned during the study period
- •Exclusion Criteria: Care Partner
- •planning to miss more than 2 weeks during the study period
- •behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues)
- •unable to take 2 steps independently without cane or walker
- •terminal illness (life expectancy < 1 year)
- •currently participating in another research study that could impact current study
研究组 & 干预措施
Group 2
Waitlist control
干预措施: Waitlist control (Behavioral)
Group 2
Waitlist control
干预措施: Paired PLIÉ Program (Behavioral)
Group 1
Paired PLIÉ Program
干预措施: Paired PLIÉ Program (Behavioral)
结局指标
主要结局
Quality of Life (Affected Individual, Self-report)
时间窗: 24 weeks
Quality of life in Alzheimer's disease (QOL-AD) - total score Quality of life in Alzheimer's disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) asks PWDs to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.
Caregiver Burden (Caregiver, Self-report)
时间窗: 24 weeks
Caregiver Burden Inventory (CBI) - total score Caregiver Burden Inventory (CBI) - total score This is a standard 24-item measure that includes questions about the CPs feelings about caregiving on a 5-point Likert scale with 5 domains. This measure has good internal consistency. Higher scores (range 0-96) indicate higher burden.
Cognitive Function (PWCI, Direct Assessment)
时间窗: 12 weeks
Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score This was was used to directly assess cognitive function in PWCI. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-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. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function.
Physical Function (Affected Individual, Direct Assessment)
时间窗: 24 weeks
Short Physical Performance Battery (SPPB) - total score The Short Physical Performance Battery (SPPB) was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. It includes direct assessment of lower body strength, balance and gait speed that provide a summary score (range 0-12). Higher scores indicate higher performance ability
Cognitive Function (Affected Individual, Direct Assessment)
时间窗: 24 weeks
Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to directly assess cognitive function in PWD. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-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. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function.
Physical Function (Affected Individual, Direct Assessment)
时间窗: 12 weeks
Short Physical Performance Battery (SPPB) - total score The Short Physical Performance Battery (SPPB) was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. It includes direct assessment of lower body strength, balance and gait speed that provide a summary score (range 0-12). Higher scores indicate higher performance ability.
Quality of Life (Affected Individual, Self-report)
时间窗: 12 weeks
Quality of life in Alzheimer's disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) asks PWDs to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.
Caregiver Burden (Caregiver, Self-report)
时间窗: 12 weeks
Caregiver Burden Inventory (CBI) - total score This is a standard 24-item measure that includes questions about the CPs feelings about caregiving on a 5-point Likert scale with 5 domains. This measure has good internal consistency. Higher scores (range 0-96) indicate higher burden.
次要结局
- Independence (Affected Individual, Caregiver Report)(24 weeks)
- Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)(24 weeks)
- Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report)(12 weeks)
- Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)(24 weeks)
- Falls Efficacy (Affected Individual, Self-report)(24 weeks)
- Falls Efficacy (Affected Individual, Caregiver Report)(24 weeks)
- Quality of Life (Affected Individual, Caregiver Report)(12 weeks)
- Mood (Caregiver, Self-report)(24 weeks)
- Feelings About Caregiving (Caregiver, Self-report)(24 weeks)
- Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report)(24 weeks)
- Quality of Life (Person With Dementia, Caregiver Report)(24 weeks)
- Independence (Affected Individual, Caregiver Report)(12 weeks)
- Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)(12 weeks)
- Feelings About Caregiving (Caregiver, Self-report)(12 weeks)
- Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)(12 weeks)
- Falls Efficacy (Affected Individual, Self-report)(12 weeks)
- Falls Efficacy (Affected Individual, Caregiver Report)(12 weeks)
- Mood (Caregiver, Self-report)(12 weeks)