Clinical trial NCT03526146: Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)
Official title: Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-05-16
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study participants will receive the PLIE intervention program (1 hour, 2 days/week, for 12 weeks) at the San Francisco VA.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The goal of the proposed study is to perform a randomized, controlled trial (RCT) to test the efficacy of a novel integrative exercise program called Preventing Loss of Independence through Exercise (PLIE) on function and quality of life in older adults living in the community with Mild cognitive impairment (MCI), which is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia.

Because current dementia medications have minimal impact on function and quality of life and do not stop or slow the disease course, it would be desirable if there were an intervention that could prevent or delay the onset of full-blown dementia. Moreover, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia and MCI.

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 have completed a pilot study of the PLIE program at an adult day center in San Francisco, CA. Results suggest that PLIE 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 this pilot study results by performing a RCT of PLIE for individuals who have MCI but who do not yet have dementia.

Study participants will be randomly assigned to receive the PLIE intervention program (1 hour, 2 days/week, 4 months) or Usual Care (UC) control (standard senior center activities, 1 hour, 2 days/week, 4 months) (N=40, 20/group) using a wait-list 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). The investigators will also look at the 4-month change in the following neuroimaging measures: brain volume with structural magnetic resonance imaging (MRI), functional connectivity with resting-state functional MRI, cerebral perfusion with arterial-spin labeled MRI. To account for the wait-list design, all outcomes will be assessed at baseline, 4 months and 8 months.

The proposed project will address a critically important health problem related to optimizing functional status and quality of life in older individuals with MCI. The current study will utilize rigorous research methods to test the efficacy of an innovative and promising new program for older adults with MCI. If the program is successful, the investigators will work with VA and community-based organizations to implement PLIE more broadly.

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

Primary outcomes:
measure: Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: baseline to 12 weeks
measure: Interoceptive Self-Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
timeFrame: baseline to week 12
measure: Attention Regulation, Assessed With the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
timeFrame: baseline to week 12
measure: PROMIS Social Isolation
timeFrame: baseline to week 12
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: University of California, San Francisco
name: Linda I Chao, 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.