Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery (SPPB)-Modified
研究概览
简要总结
Nearly 1 in 10 older Veterans have dementia, which is a devastating condition that leads to a progressive loss of independence and functional status. Currently available dementia medications do not alter the disease course. Therefore, it is critically important to identify effective strategies for helping older Veterans living with dementia to enhance their functional status and quality of life. The investigators have developed a novel, integrative group movement program called Preventing Loss of Independence through Exercise (PLIE) that incorporates elements from Eastern and Western exercise modalities and is designed to build and maintain the capacity to perform basic functional movements while increasing mindful body awareness and enhancing social connection. Pilot study results suggested that PLIE is associated with meaningful improvements in physical function, cognitive function and quality of life as well as reduced caregiver burden. The goal of the current study is to perform a full-scale randomized, controlled trial to test the efficacy of PLIE in older Veterans with dementia.
详细描述
The goal of the proposed study is to perform a randomized, controlled trial (RCT) to test the efficacy of a novel integrative group movement program called Preventing Loss of Independence through Exercise (PLIE) on function and quality of life in older Veterans living in the community with dementia. Dementia is a devastating condition that affects nearly 1 in 10 older Veterans (~1 million individuals). Current dementia medications have minimal impact on function and quality of life and do not stop or slow the disease course; however, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia. PLIE was developed based on recent discoveries in neuroscience and experimental psychology that have found that, although explicit memory (the ability to consciously recall new information) is impaired in individuals with dementia, implicit memory (unconscious learning that typically occurs through repeated exposure) is relatively preserved. Therefore, PLIE focuses on training procedural memory (unconscious learning of procedures) to build the strength and capacity to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing). In addition, to maximize the benefits of the training, PLIE integrates elements of Eastern and Western exercise modalities to develop mindful body awareness and enhance social connection. The investigators completed a pilot study of the PLIE program at an adult day center in San Francisco, CA, finding that it was associated with clinically meaningful improvements in cognitive function, physical performance and quality of life as well as reduced caregiver burden when compared with usual care at the facility. The current study will enable the investigators to build on these pilot study results by performing a full-scale RCT at adult day centers in Northern California. Most VA Medical Centers currently contract with community-based organizations to provide adult day care to eligible Veterans with dementia. Therefore, sites for the current study will be adult day centers that have current contracts with local VA medical centers. Within each center, study participants will be randomly assigned to receive the PLIE intervention program (1 hour, 2-3 days/week, 4 months) or Usual Care (UC) control (standard center activities, 1 hour, 2-3 days/week, 4 months) (N=120, 60/group) using a waitlist design. The co-primary outcomes are 4-month change in physical function (Short Physical Performance Battery, SPPB), cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale, ADAS-cog) and quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Changes in caregiver feelings (Caregiver Burden Inventory, CBI; Positive Aspects of Caregiving, PAC), mood (Geriatric Depression Scale, GDS), fear of falling (Falls Efficacy Scale, FES), independence (Disability Assessment for Dementia, DAD) and dementia-related behaviors (Neuropsychiatric Inventory, NPI) will be examined as secondary outcomes. To account for the waitlist design, all outcomes will be assessed at baseline, 4 months and 8 months. The proposed project will address a critically important Veterans' health problem related to optimizing functional status and quality of life in older Veterans with dementia. It is directly responsive to Request for Applications (RFA) RX-14-011 (RR&D Merit Review Award for Research on Amyotrophic Lateral Sclerosis, Parkinson's Disease and Alzheimer's Disease), which has identified "pioneering new and innovative rehabilitation methodologies to restore function and improve quality of life for Veterans living with [these] neurodegenerative diseases" as a "major focus." Many patients and caregivers currently feel that little is being done to help individuals with dementia maintain function and quality of life. The current study will utilize rigorous research methods to test the efficacy of an innovative and promising new program for older adults with dementia. If the program is successful, the investigators will work with VA and community-based organizations to implement PLIE more broadly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •120 dyads of individuals with dementia and their primary caregivers will be enrolled, with a goal of 20 dyads per intervention site.
- •Veterans with dementia will be prioritized for enrollment at each site.
- •Enrollment will be opened to non-Veterans with dementia at the site if there are not an adequate number of Veterans to fill the group.
- •Caregivers are not required to be Veterans, but their participation is necessary because they are providing care to the primary participants, many of whom will be Veterans.
- •Inclusion criteria, primary participant:
- •diagnosis of memory loss or dementia
- •mild to moderate severity (defined as Clinical Dementia Rating of 0.5, 1 or 2)
- •English language fluency
- •attendance or willingness to attend adult day health center at least 2 days/week on days that PLIE will be offered
- •Inclusion criteria, caregivers:
- •Provide care for primary participant
- •Able to answer study questionnaires related to participant's functional status, dementia-related behaviors, quality of life and their own burden.
- •English language fluency
排除标准
- •Exclusion criteria, primary participant:
- •Plans to change days of attendance during the study period so that participant would no longer be attending on at least 2 PLIE days/week.
- •Planning to leave the facility during the study period and not willing to come for PLIE classes at least 2 days/week
- •Severe vision or hearing impairment (e.g., unable to see or hear well enough to follow instructions)
- •Several physical impairment (e.g., paralysis or hemi-paralysis; wheel-chair or bed bound)
- •Severe mental health condition (e.g., uncontrolled depression, PTSD, bipolar disorder)
- •Limited life expectancy (e.g., enrolled in or eligible for hospice; metastatic cancer)
- •Started dementia medication (cholinesterase inhibitor or memantine) in past 3 months.
- •Planning to change dementia medication during the study period
- •Current participation in another research study
- •Lack of legally authorized representative to provide consent
- •Lack of consent/assent to study procedures
- •Exclusion criteria, caregivers:
- •Severe vision or hearing impairment (e.g., unable to see or hear well enough to follow instructions)
- •Several physical impairment (e.g., paralysis or hemi-paralysis; wheel-chair or bed bound)
- •Severe mental health condition (e.g,. uncontrolled depression, PTSD, bipolar)
- •Limited life expectancy (e.g., enrolled in or eligible for hospice; metastatic cancer)
- •lack of consent
结局指标
主要结局
Short Physical Performance Battery (SPPB)-Modified
时间窗: 4 months
The SPPB was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. Lower body strength is assessed based on time to complete 5 chair stands without using arms. Balance is assessed based on the ability to hold different stands for 10 seconds, including the side-by-side, semi-tandem and full tandem stands. Mobility is assessed based on usual walking speed over a 3-meter walking course. The total SPPB score is the sum of the 3 component scores and may range from 0 to 12. Higher scores reflect better performance.
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)
时间窗: 4 months
The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) is one of the most commonly used outcome measures in dementia drug treatment trials and is one of the measures considered by the Food and Drug Administration for approval of dementia medications. 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. Scores may range from 0 to 70 with higher scores reflecting worse cognitive function. Prior studies have found the ADAS-cog to be valid and reliable with Cronbach's alpha greater than 0.8 and test-retest reliability above 0.9.
Quality of Life Scale in Alzheimer's Disease (QOL-AD)
时间窗: 4 months
The Quality of Life Scale in Alzheimer's Disease (QOL-AD) is a standard quality of life measure that asks parallel questions of affected individuals and caregivers. Current quality of life is rated as poor (1 point), fair (2 points), good (3 points) or excellent (4 points) 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. Scores may range from 13 to 52 with higher scores reflecting better quality of life. Prior studies have found that the QOL-AD is a valid and reliable measure, with Cronbach's alpha of 0.84 for patient reports and 0.86 for caregiver reports and interrater reliability based on Cohen's kappa values \>0.70.
次要结局
- Caregiver Burden Inventory (CBI)(4 months)
- Neuropsychiatric Inventory - Number (NPI-N)(4 months)
- Chair Stand Time(4 months)
- Quality of Life in Alzheimer's Disease - CG Report About Participant(4 months)
- Positive Aspects of Caregiving (PAC)(4 months)
- Balance Score(4 months)
- Falls Efficacy Scale (FES) - Participant Report(4 months)
- Disability Assessment for Dementia (DAD)(4 months)
- Neuropsychiatric Inventory - Frequency*Severity (NPI-FS)(4 months)
- Neuropsychiatric Inventory - Caregiver Distress(4 months)
- Geriatric Depression Scale (GDS)(4 months)
- Sit & Reach(4 months)
- Usual Gait Speed(4 months)
- Timed Up & Go(4 months)