Clinical trial NCT02350127: Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia
Official title: Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dementia
Alzheimer's Disease
Keywords: dementia
clinical trial
behavioral intervention
exercise
complementary and alternative medicine
cognition
function
quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: LifeLong Marin Adult Day Health Center
name: Institute on Aging, San Francisco, CA
name: Catholic Charities
name: Alzheimer's Services of the East Bay
name: Bayview Hunters Point Adult Day Health Center
name: Primrose Alzheimer's Living, Inc
First posted: 2015-01-29
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of Life Scale in Alzheimer's Disease (QOL-AD)
timeFrame: 4 months
measure: Short Physical Performance Battery (SPPB)-Modified
timeFrame: 4 months
measure: Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)
timeFrame: 4 months
Secondary outcomes:
measure: Caregiver Burden Inventory (CBI)
timeFrame: 4 months
measure: Disability Assessment for Dementia (DAD)
timeFrame: 4 months
measure: Neuropsychiatric Inventory - Number (NPI-N)
timeFrame: 4 months
measure: Neuropsychiatric Inventory - Frequency*Severity (NPI-FS)
timeFrame: 4 months
measure: Neuropsychiatric Inventory - Caregiver Distress
timeFrame: 4 months
measure: Quality of Life in Alzheimer's Disease - CG Report About Participant
timeFrame: 4 months
measure: Geriatric Depression Scale (GDS)
timeFrame: 4 months
measure: Positive Aspects of Caregiving (PAC)
timeFrame: 4 months
measure: Chair Stand Time
timeFrame: 4 months
measure: Balance Score
timeFrame: 4 months
measure: Usual Gait Speed
timeFrame: 4 months
measure: Timed Up & Go
timeFrame: 4 months
measure: Sit & Reach
timeFrame: 4 months
measure: Falls Efficacy Scale (FES) - Participant Report
timeFrame: 4 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Deborah E Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.
citation: Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14.