DementiaPhase 2/3PLIE-VANCT02350127

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

A Phase 2/3 study testing Preventing Loss of Independence through Exercise (PLIE) in people with Dementia and Alzheimer's Disease, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Dementia, Alzheimer's Disease
What is being tested?: Preventing Loss of Independence through Exercise (PLIE)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteUnited States
Study dates: 4 May 2015to 31 Dec 2018
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.
diagnosis of memory loss or dementia
mild to moderate severity (defined as Clinical Dementia Rating of 0.5, 1 or 2)

Show all 11Show fewer

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

Who cannot join

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)

Show all 16Show fewer

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)
lack of consent

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121

Other trials in United States

About this study

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.

Read the detailed description

The goal of the proposed study is to perform a randomized, controlled trial (RCT) to test the efficacy of a novel integrative group movement 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 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), mood (Geriatric Depression Scale, GDS), 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.

Conditions: Dementia, Alzheimer's Disease
Being tested: Preventing Loss of Independence through Exercise (PLIE), Usual Care
Keywords: dementia, clinical trial, behavioral intervention, exercise, complementary and alternative medicine, cognition, function, quality of life
Medical subject headings: Dementia, Alzheimer Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preventing Loss of Independence through Exercise (PLIE)Behavioural
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.
Usual CareBehavioural
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.

Study groups in NCT02350127
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Preventing Loss of Independence through Exercise (PLIE); Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 4 months

Secondary outcomes (14)

Caregiver Burden Inventory (CBI)
The Caregiver Burden Inventory (CBI) is a standard measure that includes 24 items and 5 domains. Caregivers are asked to rate how often each statement describes their feelings (never, rarely, sometimes, quite frequently, nearly always). The total score may range from 0 to 96 with higher scores reflecting greater feelings of burden.
Measured: 4 months
Disability Assessment for Dementia (DAD)
The Disability Assessment for Dementia (DAD) is a standard measure of functional independence that asks caregivers whether the participant performed 17 basic and 23 instrumental activities of daily living over the past 2 weeks without reminder or assistance. Each item is rated as yes, no, or not applicable (i.e., never performed, no opportunity to perform). The score reflects the percent of items performed independently, excluding those that were not applicable. Therefore, scores may range from 0 to 100 with higher scores reflecting greater independence. The DAD has high established validity and high test-retest reliability (ICC, 0.96), inter-rater reliability (ICC, 0.95) and internal consistency (Cronbach's alpha, 0.96).
Measured: 4 months
Neuropsychiatric Inventory - Number (NPI-N)
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-N counts the number of symptoms present. Scores may range from 0 to 12 with higher scores reflecting worse outcomes (i.e., more symptoms).
Measured: 4 months
Neuropsychiatric Inventory - Frequency*Severity (NPI-FS)
The Neuropsychiatric Inventory - Frequency*Severity subscale (NPI-FS) assesses the frequency and severity of 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) by caregiver report. NPI-FS was calculated by multiplying the frequency*severity of behaviors, which had a range of 0-144. Higher scores indicate worse outcomes (greater frequency/severity).
Measured: 4 months
Neuropsychiatric Inventory - Caregiver Distress
Measure of caregiver distress associated with 12 common dementia-related behaviors. Scores may range from 0 to 60 with higher scores reflecting greater distress.
Measured: 4 months
Quality of Life in Alzheimer's Disease - CG Report About Participant
Caregiver assessment of participant's quality of life. Scores may range from 13 to 52, with higher scores reflecting better quality of life.
Measured: 4 months
Geriatric Depression Scale (GDS)
Depressive symptoms were assessed in caregivers based on self-report using the GDS - short form, a 15-item yes/no scale. Scores may range from 0 to 15, with higher scores reflecting greater depressive symptomatology.
Measured: 4 months
Positive Aspects of Caregiving (PAC)
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). Total scores range from 11 to 55 with higher scores indicating more positive feelings
Measured: 4 months
Chair Stand Time
Time to complete 5 chair stands without using arms in seconds. Higher scores reflect worse (slower) performance.
Measured: 4 months
Balance Score
From Short Physical Performance Battery, including side-by-side, semi-tandem, and tandem balance. Score may range from 0 to 4, with higher scores indicating better balance.
Measured: 4 months
Usual Gait Speed
From Short Physical Performance Battery, better of two times in seconds. Higher scores reflect worse (slower) performance.
Measured: 4 months
Timed Up & Go
Measure of mobility in which participant is timed while standing up from a seated position, walking around a cone that is 8 feet away, and returning to a seated position. Higher scores reflect worse (slower) performance.
Measured: 4 months
Sit & Reach
Measure of flexibility in which participant reaches toward toes with a straight leg. Score reflect closest to touching, with positive values reflecting past toes and negative values reflecting not touching toes.
Measured: 4 months
Falls Efficacy Scale (FES) - Participant Report
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). Scores may range from 10 to 40 with higher scores reflecting worse outcomes (i.e., greater concern about falling).
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 201531 Dec 2018

First posted29 Jan 2015 (estimated)
Study start4 May 2015
Primary completion13 Dec 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DementiaStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02350127
Sponsor's protocol ID: D1507-I
Other IDs: 5I01RX001507-02
Acronym: PLIE-VA
Status last verified: Jun 2020
First submitted: 16 Jan 2015
Last updated: 18 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25671576
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.
PubMed 25022459

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia
ClinicalTrials.gov ID: NCT02350127
Acronym / sponsor ID: PLIE-VA / D1507-I
Conditions: Dementia, Alzheimer's Disease
Keywords: dementia, clinical trial, behavioral intervention, exercise, complementary and alternative medicine, cognition, function, quality of life
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: LifeLong Marin Adult Day Health Center, Institute on Aging, San Francisco, CA, Catholic Charities, Alzheimer's Services of the East Bay, Bayview Hunters Point Adult Day Health Center, Primrose Alzheimer's Living, Inc
Study start: 4 May 2015 (actual)
Primary completion: 13 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 29 Jan 2015 (estimated)
Results: Posted 18 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Immediate Start	Experimental	Behavioral: Preventing Loss of Independence through Exercise (PLIE), Behavioral: Usual CareThe 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.
Delayed Start	Active comparator	Behavioral: Preventing Loss of Independence through Exercise (PLIE), Behavioral: Usual CareStudy 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

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.
diagnosis of memory loss or dementia

Key exclusion criteria (16 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Preventing Loss of Independence through Exercise (PLIE)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.	Behavioural	Delayed Start, Immediate Start
Usual CareUsual 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.	Behavioural	Delayed Start, Immediate Start

Primary outcome

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.
Short Physical Performance Battery (SPPB)-Modified
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. Higher scores reflect better performance.
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. 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.

14 secondary outcomes

Caregiver Burden Inventory (CBI)
Time frame: 4 months
Disability Assessment for Dementia (DAD)
Time frame: 4 months
Neuropsychiatric Inventory - Number (NPI-N)
Time frame: 4 months
Neuropsychiatric Inventory - Frequency*Severity (NPI-FS)
Time frame: 4 months
Neuropsychiatric Inventory - Caregiver Distress
Time frame: 4 months
Quality of Life in Alzheimer's Disease - CG Report About Participant
Time frame: 4 months
Geriatric Depression Scale (GDS)
Time frame: 4 months
Positive Aspects of Caregiving (PAC)
Time frame: 4 months
Chair Stand Time
Time frame: 4 months
Balance Score
Time frame: 4 months
Usual Gait Speed
Time frame: 4 months
Timed Up & Go
Time frame: 4 months
Sit & Reach
Time frame: 4 months
Falls Efficacy Scale (FES) - Participant Report
Time frame: 4 months

Results and safety

Results posted to the registry on 18 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Start	44	33
Delayed Start	44	35

Primary outcome: Quality of Life Scale in Alzheimer's Disease (QOL-AD)

Time frame: 4 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Immediate Start n = 42	Delayed Start n = 43
Value	38.8 (6.2)	40.0 (4.3)

Immediate Start vs Delayed Start: Mean Difference (Final Values): 1.79 (95% CI -0.59 to 4.18), p = 0.14, Mixed Models Analysis
Immediate Start vs Delayed Start: Mean Difference (Final Values): 2.9 (95% CI 0.2 to 5.6), p = 0.03, Mixed Models Analysis

Primary outcome: Short Physical Performance Battery (SPPB)-Modified

Time frame: 4 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Immediate Start n = 42	Delayed Start n = 43
Value	6.1 (3.0)	6.1 (3.2)

Immediate Start vs Delayed Start: Mean Difference (Final Values): -0.22 (95% CI -1.23 to 0.80), p = 0.68, Mixed Models Analysis

Primary outcome: Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)

Time frame: 4 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Immediate Start n = 42	Delayed Start n = 43
Value	36.7 (13.8)	30.4 (13.2)

Immediate Start vs Delayed Start: Mean Difference (Final Values): -0.51 (95% CI -3.09 to 2.08), p = 0.70, Mixed Models Analysis

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Start	8 of 44 (18.2%)	20 of 44 (45.5%)	2 of 44
Delayed Start	10 of 44 (22.7%)	12 of 44 (27.3%)	1 of 44

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25671576Barnes 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.
Background: PubMed 25022459Wu 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.
Facebook page for PLIE programLink provided by the sponsor.
Osher Center description of PLIE programLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deborah E Barnes, PhD principal investigator

San Francisco VA Medical Center, San Francisco, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Scale in Alzheimer's Disease (QOL-AD) (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02350127, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.