Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 9/5/2018 |
| Start Date: | August 30, 2018 |
| End Date: | September 30, 2020 |
| Contact: | Linda l Chao, PhD |
| Email: | linda.chao@ucsf.edu |
| Phone: | 415-221-4810 |
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.
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.
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.
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.
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
We found this trial at
1
site
San Francisco, California 94121
Phone: 844-366-6866
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