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

This study is currently recruiting participants.
Verified June 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02350127
First Posted: January 29, 2015
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Marin Adult Day Health Center, Novato, CA
Institute on Aging, San Francisco, CA
Catholic Charities, Santa Rosa, CA
Alzheimer's Services of the East Bay
Bayview Hunters Point Adult Day Health Center
Primrose Inc Santa Rosa
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 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 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.

Condition Intervention Phase
Dementia Alzheimer's Disease Behavioral: Preventing Loss of Independence through Exercise (PLIE) Behavioral: Usual Care Control Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Short Physical Performance Battery (SPPB) [ Time Frame: 4 months ]
    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. Prior studies have found that the SPPB is valid and reliable and associated with important outcomes including disability and mortality. A recent systematic review concluded that the SPPB was one of the best tools available to measure physical performance in older adults based on reliability, validity and responsiveness.

  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: 4 months ]
    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 and is scored on an 80-point scale 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.

  • Quality of Life Scale in Alzheimer's Disease (QOL-AD) [ Time Frame: 4 months ]
    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.


Secondary Outcome Measures:
  • Disability Assessment for Dementia (DAD) [ Time Frame: 4 months ]
    The Disability Assessment for Dementia (DAD) is a standard measure of functional independence that asks caregivers to rate the participant's disability with 17 basic and 23 instrumental activities of daily living over the past 2 weeks. The DAD has high established validity and high test-retest reliability (ICC, 0.96), inter-rater reliability (ICC, 0.95) and internal consistency (Chronbach's alpha, 0.96).

  • Geriatric Depression Scale (GDS) [ Time Frame: 4 months ]
    Depressive symptoms in participants and caregivers will be assessed based on self-report using the GDS - short form, a 15-item yes/no scale that is valid in people with and without dementia.

  • Falls Efficacy Scale (FES) [ Time Frame: 4 months ]
    A standard measure of falls efficacy that can be administered to people with cognitive impairment or caregivers and asks about concern about the possibility of falling doing 10 daily tasks (e.g., taking a bath or shower) on a 4-point likert scale (not at all, somewhat, fairly or very concerned).

  • Caregiver Burden Inventory (CBI) [ Time Frame: 4 months ]
    The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). The NPI has good test-retest reliability (0.79-0.86) and good internal consistency (Cronbach's alpha, 0.87-0.88).

  • Neuropsychiatric Inventory (NPI) [ Time Frame: 4 months ]
    The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). The NPI has good test-retest reliability (0.79-0.86) and good internal consistency (Cronbach?s alpha, 0.87-0.88).

  • Positive Aspects of Caregiving (PAC) [ Time Frame: 4 months ]
    A standard measure that asks caregivers to rate their agreement/disagreement with 11 statements about positive aspects of caregiving on a 5-point likert scale (disagree a lot ... agree a lot).


Estimated Enrollment: 120
Actual Study Start Date: May 4, 2015
Estimated Study Completion Date: January 31, 2019
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLIE
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: Preventing Loss of Independence through Exercise (PLIE)
PLI 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.
Active Comparator: Usual Care Control
Study participants who are randomized to the Usual Care (UC) control group will continue to participate in usual activities at the adult day center, which include a combination of daily physical, mental and social activities.
Behavioral: Usual Care Control
Study participants who are randomized to the Usual Care (UC) control group will continue to participate in usual activities at the adult day center, which include a combination of daily physical, mental and social activities.

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 Veterans living in the community with dementia. Dementia is a devastating condition that affects nearly 1 in 10 older Veterans (~1 million individuals). Current dementia medications have minimal impact on function and quality of life and do not stop or slow the disease course; however, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia. 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 recently completed a pilot study of the PLIE program at an adult day center in San Francisco, CA, finding that it 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 these pilot study results by performing a full-scale RCT at adult day centers in Northern California. Most VA Medical Centers currently contract with community-based organizations to provide adult day care to eligible Veterans with dementia. Therefore, sites for the current study will be adult day centers that have current contracts with local VA medical centers. Within each center, study participants will be randomly assigned to receive the PLIE intervention program (1 hour, 2-3 days/week, 4 months) or Usual Care (UC) control (standard center activities, 1 hour, 2-3 days/week, 4 months) (N=120, 60/group) using a waitlist 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). Changes in caregiver feelings (Caregiver Burden Inventory, CBI; Positive Aspects of Caregiving, PAC), fear of falling (Falls Efficacy Scale, FES), independence (Disability Assessment for Dementia, DAD) and dementia-related behaviors (Neuropsychiatric Inventory, NPI) will be examined as secondary outcomes. To account for the waitlist design, all outcomes will be assessed at baseline, 4 months and 8 months. The proposed project will address a critically important Veterans' health problem related to optimizing functional status and quality of life in older Veterans with dementia. It is directly responsive to Request for Applications (RFA) RX-14-011 (RR&D Merit Review Award for Research on Amyotrophic Lateral Sclerosis, Parkinson's Disease and Alzheimer's Disease), which has identified "pioneering new and innovative rehabilitation methodologies to restore function and improve quality of life for Veterans living with [these] neurodegenerative diseases" as a "major focus." Many patients and caregivers currently feel that little is being done to help individuals with dementia maintain function and quality of life. The current study will utilize rigorous research methods to test the efficacy of an innovative and promising new program for older adults with dementia. If the program is successful, the investigators will work with VA and community-based organizations to implement PLIE more broadly.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 120 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.

Inclusion criteria, primary participant:

  • 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

Inclusion criteria, caregivers:

  • 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

Exclusion Criteria:

Exclusion criteria, primary participant:

  • 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

Exclusion criteria, caregivers:

  • 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)
  • lack of consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350127


Contacts
Contact: Deborah E Barnes, PhD (415) 221-4810 ext 4221 deborah.barnes4@va.gov
Contact: Wolf Mehling, MD (415) 353-9506 wolf.mehling@ucsf.edu

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Tatiana Dannenbaum, BA    415-221-4810 ext 22589    tatiana.dannenbaum@ucsf.edu   
Contact: Deborah E Barnes, PhD    (415) 221-4810 ext 4221    deborah.barnes4@va.gov   
Principal Investigator: Deborah E Barnes, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Marin Adult Day Health Center, Novato, CA
Institute on Aging, San Francisco, CA
Catholic Charities, Santa Rosa, CA
Alzheimer's Services of the East Bay
Bayview Hunters Point Adult Day Health Center
Primrose Inc Santa Rosa
Investigators
Principal Investigator: Deborah E Barnes, PhD San Francisco VA Medical Center, San Francisco, CA
  More Information

Additional Information:
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02350127     History of Changes
Other Study ID Numbers: D1507-I
5I01RX001507-02 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2015
First Posted: January 29, 2015
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
dementia
clinical trial
behavioral intervention
exercise
complementary and alternative medicine
cognition
function
quality of life

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders