Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia

NCT02350127 | Completed Phase 2 Results DMC

• 2 other identifiers: D1507-I5I01RX001507-02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Alzheimer's Disease

Keywords

dementia; clinical trial; behavioral intervention; exercise; complementary and alternative medicine; cognition; function; quality of life

Outcome Measures

Primary Outcomes (3)

• Quality of Life Scale in Alzheimer's Disease (QOL-AD)

  The Quality of Life Scale in Alzheimer's Disease (QOL-AD) is a standard quality of life measure that asks parallel questions of affected individuals and caregivers. Current quality of life is rated as poor (1 point), fair (2 points), good (3 points) or excellent (4 points) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Scores may range from 13 to 52 with higher scores reflecting better quality of life. Prior studies have found that the QOL-AD is a valid and reliable measure, with Cronbach's alpha of 0.84 for patient reports and 0.86 for caregiver reports and interrater reliability based on Cohen's kappa values \>0.70.

  4 months

• Short Physical Performance Battery (SPPB)-Modified

  The SPPB was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. Lower body strength is assessed based on time to complete 5 chair stands without using arms. Balance is assessed based on the ability to hold different stands for 10 seconds, including the side-by-side, semi-tandem and full tandem stands. Mobility is assessed based on usual walking speed over a 3-meter walking course. The total SPPB score is the sum of the 3 component scores and may range from 0 to 12. Higher scores reflect better performance.

  4 months

• 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.

  4 months

Secondary Outcomes (14)

• Caregiver Burden Inventory (CBI)

  4 months

• Disability Assessment for Dementia (DAD)

  4 months

• Neuropsychiatric Inventory - Number (NPI-N)

  4 months

• Neuropsychiatric Inventory - Frequency*Severity (NPI-FS)

  4 months

• Neuropsychiatric Inventory - Caregiver Distress

  4 months

Study Arms (2)

Immediate Start

EXPERIMENTAL

The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.

Behavioral: Preventing Loss of Independence through Exercise (PLIE); Behavioral: Usual Care

Delayed Start

ACTIVE COMPARATOR

Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.

Behavioral: Preventing Loss of Independence through Exercise (PLIE); Behavioral: Usual Care

Interventions

Preventing Loss of Independence through Exercise (PLIE) BEHAVIORAL

PLIE is an integrative group movement 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 between sitting and 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.

Delayed Start; Immediate Start

Usual Care BEHAVIORAL

Usual care activities will vary between participants. Some will be attending the adult day center and may be engaging in structured physical, mental and/or social activities. Other participants will be living in the community and may engage in physical, mental, and/or social activities on their own or with a caregiver.

Delayed Start; Immediate Start

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• LifeLong Marin Adult Day Health Center: collaborator
• Institute on Aging, San Francisco, CA: collaborator
• Catholic Charities: collaborator
• Alzheimer's Services of the East Bay: collaborator
• Bayview Hunters Point Adult Day Health Center: collaborator
• Primrose Alzheimer's Living, Inc: 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Facebook page for PLIE program
• Osher Center description of PLIE program
• SFVA link to ongoing research studies

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Behavior

Limitations and Caveats

Final enrollment lower than planned due to: 1) unexpected study site relocation and 2) enrollment difficulty at one study site. In addition, withdrawal was higher than anticipated primarily due to declining health status unrelated to the study.

Results Point of Contact

• Title: Dr. Deborah Barnes, PI
• Organization: San Francisco VA

deborah.barnes4@va.gov

415-221-4810

Study Officials

• Deborah E Barnes, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 29, 2015
• Study Start: May 4, 2015
• Primary Completion: December 13, 2018
• Study Completion: December 31, 2018
• Last Updated: June 18, 2020
• Results First Posted: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)