Phase 3
N=88
Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia
Dementia · Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02350127 ↗Enrolled (actual)
88
Serious AEs
20.5%
Results posted
Jun 2020
Primary outcome: Primary: Quality of Life Scale in Alzheimer's Disease (QOL-AD) — 38.8; 40.0 score on a scale — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Preventing Loss of Independence through Exercise (PLIE) (Behavioral); Usual Care (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life Scale in Alzheimer's Disease (QOL-AD) |
38.8; 40.0 | 0.14 |
| PRIMARY Short Physical Performance Battery (SPPB)-Modified |
6.1; 6.1 | 0.68 |
| PRIMARY Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) |
36.7; 30.4 | 0.70 |
| SECONDARY Caregiver Burden Inventory (CBI) |
31.8; 32.0 | 0.02 sig |
| SECONDARY Disability Assessment for Dementia (DAD) |
52.3; 65.5 | 0.47 |
| SECONDARY Neuropsychiatric Inventory - Number (NPI-N) |
4.0; 3.5 | 0.99 |
| SECONDARY Neuropsychiatric Inventory - Frequency*Severity (NPI-FS) |
15.9; 14.1 | 0.98 |
| SECONDARY Neuropsychiatric Inventory - Caregiver Distress |
8.1; 8.3 | 0.80 |
| SECONDARY Quality of Life in Alzheimer's Disease - CG Report About Participant |
31.2; 33.1 | 0.38 |
| SECONDARY Geriatric Depression Scale (GDS) |
3.3; 3.3 | 0.075 |
| SECONDARY Positive Aspects of Caregiving (PAC) |
36.9; 39.5 | 0.35 |
| SECONDARY Chair Stand Time |
17.7; 18.2 | 0.35 |
| SECONDARY Balance Score |
2.4; 2.4 | 0.54 |
| SECONDARY Usual Gait Speed |
5.6; 5.6 | 0.69 |
| SECONDARY Timed Up & Go |
15.7; 16.1 | 0.88 |
| SECONDARY Sit & Reach |
-4.3; -4.0 | 0.26 |
| SECONDARY Falls Efficacy Scale (FES) - Participant Report |
14.2; 14.1 | 0.08 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02350127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.