Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)

NCT03526146 | Completed Results

• 1 other identifier: 17-23034
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)

  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. Because we examined the difference from baseline to post-treatment, a positive change score indicates improvement while a negative change score indicates decline.

  baseline to 12 weeks

Secondary Outcomes (4)

• Short Physical Performance Battery (SPPB)

  baseline to 12 weeks

• Interoceptive Self-Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)

  baseline to week 12

• Attention Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)

  baseline to week 12

• PROMIS Social Isolation

  baseline to week 12

Study Arms (1)

PLIE

EXPERIMENTAL

PLIE is an integrative exercise program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.

Behavioral: Behavioral: Preventing Loss of Independence through Exercise (PLIE)

Interventions

Behavioral: Preventing Loss of Independence through Exercise (PLIE) BEHAVIORAL

PLIE is an integrative exercise program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.

PLIE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• United States Department of Defense: collaborator

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (2)

• 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.

  PMID: 25671576 RESULT

• 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.

  PMID: 25022459 RESULT

Related Links

• Facebook page for PLIE program
• Osher Center description of PLIE program

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

We did not have an active control group. Therefore, we cannot rule out the possibility that practice, context, or placebo effects may have contributed to the behavioral findings and self report measures. Second, because the study only had one arm, the assessors were unblinded, which may have led to potential biases. A third limitation is that we performed numerous statistical tests without adjusting for multiple comparisons; therefore, there is a potential of false positives.

Results Point of Contact

• Title: Linda L. Chao
• Organization: San Francisco Veterans Affairs Health Care System, San Francisco, CA

linda.chao@ucsf.edu

415-221-4810

Study Officials

• Linda I Chao, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will receive the PLIE intervention program (1 hour, 2 days/week, for 12 weeks) at the San Francisco VA.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: August 30, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)