N/A
N=33
Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03526146 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog) — 2.83 score on a scale — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral: Preventing Loss of Independence through Exercise (PLIE) (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog) |
2.83 | 0.002 sig |
| SECONDARY Short Physical Performance Battery (SPPB) |
-0.8 | 0.047 sig |
| SECONDARY Interoceptive Self-Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) |
-0.8 | 0.006 sig |
| SECONDARY Attention Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) |
-0.5 | 0.05 |
| SECONDARY PROMIS Social Isolation |
1.7 | 0.009 sig |
Summary
Nearly 1 in 10 older Americans have dementia, which is a devastating condition that leads to a progressive loss of independence and functional status. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. The investigators have developed a novel, integrative exercise 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 suggest that PLIE is associated with meaningful improvements in physical function, cognitive function and quality of life in individuals with dementia, as well as reduced caregiver burden. The goal of the current study is to perform a randomized, controlled trial to test the efficacy of PLIE in older adults who have MCI but who do not yet have dementia. The investigators will also investigate the neural mechanisms underlying PLIE by acquiring brain imaging measures.
Eligibility Criteria
Inclusion Criteria
- diagnosis of Mild Cognitive Impairment (MCI) by primary care physician and/or neurologist
- English language fluency
- willing to attend PLIÉ classes 2 days/week
- ambulatory and able to take 2 steps without cane or walker; living in the community in a private home or apartment
Exclusion Criteria
- Behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues)
- Unable to attend 2 PLIÉ classes/week during the study period
- Physical or mental health condition that would make participation difficult (e.g., active psychosis, limited life expectancy)
- Contraindications to magnetic resonance imaging (MRI), including claustrophobia severe enough to prevent MRI examination, and presence of ferrometallic objects in the body that would interfere with MRI examination and/or cause a safety risk (e.g., pace makers, implanted stimulators, pumps).
- Started dementia medication (cholinesterase inhibitor or memantine) in past 3 months
- Planning to start/change any psychotropic medication during the study period
- Current participation in another research study
Data sourced from ClinicalTrials.gov (NCT03526146). 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.