DementiaPLIE-CLCNCT06972004
Preventing Loss of Independence Through Exercise in Community Living Centers
A study testing Preventing Loss of Independence through Exercise (PLIE) in people with Dementia and Cognitive Dysfunction, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Approximately 40,000 older Veterans with complex care needs receive long-term care in VA Community Living Centers (CLCs). Many CLC staff have limited specialized training to engage Veterans with dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Dysfunction
- 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
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Jun 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- VA Community Living Centers (CLCs) internal facilitators/champions Inclusion criteria:
- Full-time CLC clinical staff member (including registered nurses, certified nursing assistants, nurse aids, recreation therapists, occupational therapists, physical therapists, mental health professionals or others)
- Willingness to facilitate PLIÉ-CLC implementation at their site
- Willingness to participate in initial and debrief site visit
- PLIÉ-CLC staff instructors Inclusion criteria:
- CLC clinical staff member or volunteer interested in learning to lead PLIÉ-CLC classes
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- Willingness to participate in remote training process
- Willingness to lead PLIÉ classes locally, including tracking attendance and other process measures
- Willingness to participate in initial and debrief site visits and biweekly check-ins
- Veteran residents of Community Living Centers (CLCs) Inclusion criteria:
- Identification and random selection process for Veteran resident participants in PLIÉ-CLC staff training program: For each internal facilitator/champion, the research team will create a list of residents who meet the following eligibility criteria:
- Cognitive impairment (defined as documented diagnosis of ADRD or other neurocognitive disorder and/or clinician judgment)
- Long-stay resident (anticipated length of stay 120 days)
- Ability to sit in a standard chair or wheelchair unaided for a 1-hour class
- English language proficiency
- Current clinical care relationship (defined as documentation of one or more clinical encounters or care provided to the resident during the previous 2 months).
- VA Community Living Centers (CLCs) directors Inclusion criteria:
- Recommended by VHA leader as likely to be 'early adopter' based on successful implementation of program such as STAR-VA OR
- g based on patient population (primarily palliative care or long stay maintenance/custodial care
Who cannot join
- VA Community Living Centers (CLCs) internal facilitators/champions exclusion Criteria:
- Planning to leave the facility in next 12 months
- PLIÉ-CLC staff instructors exclusion criteria:
- Planning to leave the facility in next 12 months
- Veteran residents of Community Living Centers (CLCs) exclusion Criteria:
- Comatose
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- Bedbound
- Severe hearing, visual or communication challenges (i.e., unable to hear, see or understand well enough to participate)
- Limited life expectancy
- Lack of ability to assent to study procedures and does not have an LAR
- VA Community Living Centers (CLCs) Directors exclusion criteria:
- Lack of willingness or interest in participating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
About this study
Official title: Preventing Loss of Independence Through Exercise in Community Living Centers: An Effectiveness-Implementation Trial
Approximately 40,000 older Veterans with complex care needs receive long-term care in VA Community Living Centers (CLCs). Many CLC staff have limited specialized training to engage Veterans with dementia. Preventing Loss of Independence through Exercise (PLIÉ) is a gentle, multi-domain, group movement program for people with cognitive impairment that has shown physical, cognitive, social, and emotional benefits. This effectiveness-implementation study will train interprofessional CLC staff via a remote program and evaluate PLIÉ-CLC delivered as part of routine clinical care at up to 12 VA CLCs. We will assess resident physical function (primary outcome) and secondary outcomes (e.g., social engagement, mood, cognition, behaviors, falls, pain, and quality of life), as well as person-centered care practices, staff engagement, burnout, and workplace climate, and the sustainment of the program after external facilitation ends.
Read the detailed description
Background \& Significance: Many Veterans in CLCs have comorbid neurocognitive, mental health, and physical impairments; staff often lack specialized training for optimal engagement. PLIÉ-CLC adapts a structured, mind-body movement program for CLC residents (including those using wheelchairs) and provides an experiential staff training model. Prior VA work developed and piloted a remote PLIÉ staff training program with >50 staff trained across multiple sites.
Design: A Type 2 Hybrid Effectiveness-Implementation study using a Stepped Wedge Cluster Randomized Trial (SW-CRT) across up to 12 CLCs. Phases: Pre-implementation planning \& champion training; Implementation (remote staff training + staff-delivered PLIÉ groups); Sustainment. Delivery of PLIÉ-CLC classes during Implementation/Sustainment is considered usual clinical care; research activities include staff training and evaluation measures.
Outcomes \& Timepoints: Primary: change in physical function from MDS 3.0 Section G. Secondary: mood, cognition, behaviors, falls, pain, social engagement (0, 3, 6 months), resident/staff PLIÉ Experience (residents at 3 months; staff at 3, 6, 12 months), plus exploratory incontinence (MDS). Implementation outcomes include reach, adoption, fidelity, maintenance (e.g., sustainment threshold ≥1 group/week), (0, 3, 6, 12) .
Risks \& Precautions: Minimal risk comparable to routine physical activity programs; potential exercise-related injuries (e.g., strain/soreness, joint pain, falls) mitigated via trained staff instructors and graded movement progressions; responding to questionnaires may be uncomfortable, with procedures to minimize discomfort including voluntary nature of completing specific items.
- Conditions
- Dementia, Cognitive Dysfunction
- Being tested
- Preventing Loss of Independence through Exercise (PLIE)
- Keywords
- health-related quality of life, Social Participation, Accidental Falls, Pain, Movement, Behavior, neurocognitive disorder, nursing homes, implementation science
- Medical subject headings
- Dementia, Cognitive Dysfunction, Pain, Behavior, Neurocognitive Disorders
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
Also called PLIE-CLC
Preventing Loss of Independence through Exercise (PLIÉ) is a multi-domain, mind-body, group movement program for people with dementia that improves quality of life.
Classes begins and ends with fully body tapping/massaging and breathing exercises that bring participants into awareness of their bodies in the present moment and create a calming ritual. Participants are invited to share appreciations of things in their lives that make them feel happy or grateful. Instructors lead participants through progressive, functional movement sequences that are designed to be repetitive (to build procedural or "muscle" memory) and to build slowly in functional complexity over time. Movements are tailored to the ability levels of the group. Resting, breathing and mindful body awareness exercises are incorporated throughout each class to provide breaks and to improve focus and attention. A non-judgmental errorless learning process is used, and all movements are performed slowly and purposefully.
| Study group | Role | What they receive |
|---|---|---|
| PLIE-CLC | Other | Preventing Loss of Independence through Exercise (PLIÉ) is a multi-domain, mind-body, group movement program for people with dementia that improves quality of life. A stepped wedge cluster randomized trial design includes: 1) a baseline data collection phase where no clusters are exposed to the intervention; 2) sequential randomized crossover to the intervention (PLIÉ-CLC); and 3) analyses that account for time trends and correlations within clusters. Randomization of facilities to PLIÉ-CLC will simply delay rollout to sites randomized later in the sequence (like a wait-list control condition). Receives: Behavioral: Preventing Loss of Independence through Exercise (PLIE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS Section G (Resident Physical Function)
The investigators will assess change in resident physical function using the Minimum Data Set (MDS) 3.0. The MDS has nearly 400 data elements, including cognitive function, physical functioning, behavioral symptoms, mood symptoms, pain and falls. Facility MDS coordinators (typically RNs) complete assessments for all Veterans in CLCs on admission, quarterly, and with changes in status. Reliability of the MDS is "very good" to "excellent" on most data items and scales. The investigators are using an 17-item MDS physical function measure that combines items from sections G1 (assistance needed with bed mobility, transferring, walking in room, walking in facility, and locomotion) and G3 (balance in standing, walking, turning around, getting on and off the toilet, and transferring) to create a continuous score that ranges from 0 (fully independent and steady at all times) to 136 (unable to do with or without assistance).
Measured: -6 to 0 months (baseline), 0-6 months, 9 months, 12 months
Secondary outcomes (17)
RISE (Staff)
The Revised Index of Social Engagement (RISE) proxy will be completed by CLC staff at 0, 6, and 12 months and includes 6 yes/no questions about Veteran engagement (e.g., Is the Veteran at ease interacting with others).
Measured: 0, 3, 6 Months
MDS (Behavior)
The investigators will assess change in resident behavior using the Minimum Data Set (MDS) 3.0.
Measured: -6 to 0 months (baseline), 0-6 months, 12 months
MDS (Cognition)
The investigators will assess change in resident cognition using the Minimum Data Set (MDS) 3.0.
Measured: -6 to 0 months (baseline), 0-6 months, 12 months
MDS (Mood)
The investigators will assess change in resident mood using the Minimum Data Set (MDS) 3.0.
Measured: -6 to 0 months (baseline), 0-6 months, 12 months
MDS (Pain)
The investigators will assess change in resident pain using the Minimum Data Set (MDS) 3.0.
Measured: -6 to 0 months (baseline), 0-6 months, 12 months
MDS (Falls)
The investigators will assess change in resident falls using the Minimum Data Set (MDS) 3.0.
Measured: -6 to 0 months (baseline), 0-6 months, 12 months
PLIE Experience Scale for Staff
Staff and residents reported survey after intervention. PLIÉ Experience measure at the end of the implementation period (6 months) and again 6 months later (12 months). This measure includes 6 items with parallel versions for staff and residents as well as an overall rating. In addition, the survey includes open-ended questions about what participants enjoyed most, changes noticed in themselves and others, and suggestions for improvements.
Measured: -6 to 0 months (baseline), 0-6 months, 12 months
PLIE Clinical Note
PLIÉ clinical note free-text descriptions from a 15% random sample of residents per site will be used to assess staff observation and documented change over time across resident secondary outcomes domains.
Measured: 0-6 months, 3 months, 9 months, 12 months
PC-PAL (Staff)
The Staff Person-Centered Care Practices in Assisted Living (PC-PAL) measure [is a validated tool to assess the degree to which the culture and practices of long-term care settings promote person-centered care in the following areas: workplace practices, social connectedness, individualized care and practices, atmosphere, and caregiver-resident relationships. To measure the impact of PLIE-CLC on key person-centered care domains among staff participants, the investigators will ask staff to complete 12 items from PC-PAL at 0, 6 and 12 months.
Measured: -6 to 0 months (baseline), 0-6 months, 12 months
AES (Staff)
The VA All Employee Survey (AES) includes validated questions related to organizational culture and employee engagement. Most items are rated on a 5-point Likert scale (strongly disagree to strongly agree). The investigators will ask staff participants to complete three subscales: workplace performance (6 items); job satisfaction (3 items); and burnout (3 items) at 0, 6 and 12 months.
Measured: -6 to 0 months (baseline), 6 months, 12 months
Reach
The investigators will use CDW data to assess the proportion and characteristics (e.g., gender, race/ethnicity) of eligible residents engaged in PLIÉ-CLC beyond initial training cases at (6, 9 and 12 months).
Measured: 3-6, 6-12 months
Qualitative Interviews
Qualitative semi-structured data will be collected from staff regarding the following topics: Blended facilitation \& Training effectiveness, facilitation \& training experience, leadership and organizational support.
Measured: 2, 4, 6, 12 months
NoMAD - Survey
Staff surveys include the 25-item Normalization Measurement Development (NoMAD). Scores on this validated measure are used to identify patterns across NPT domains, e.g., if the intervention makes sense to CLC staff (coherence) but is failing due to low engagement (cognitive participation).
Measured: 0, 6, 12 months
Adoption
Adoption will be measured by the total number and proportion of trained staff at each site who deliver PLIÉ groups after the training program. Data will be obtained from VA corporate data .
Measured: 3-6, 9, 12 months
Clinical Sustainability Assessment Tool (CSAT)
Sustainment capacity, or the ability to maintain PLIE-CLC and its benefits over time, will be evaluated with the 35-item Clinical Sustainability Assessment Tool (CSAT). Internal facilitations/champions and staff will rate the CSAT independently over time (0, 6, 12 months) to track progress and inform sustainment planning.
Measured: 0, 6, 12 months
Staff level fidelity to PLIE Protocol
The investigators will assess staff fidelity to the PLIÉ-CLC protocol and through staff teaching practicum assessments and chart review of at least a 10% random sample of PLIÉ-CLC clinical notes, which include checkboxes of key PLIÉ principles taught as well as free text descriptions of resident response. The investigators will assess for variations at the staff and facility levels.
Measured: 5, 6, 9, 12 months
PLIE Class Experience for Residents
Staff and residents reported survey after intervention. PLIÉ Experience measure at the end of the implementation period (6 months) and again 6 months later (12 months). This measure includes 6 items with parallel versions for staff and residents as well as an overall rating. In addition, the survey includes open-ended questions about what participants enjoyed most, changes noticed in themselves and others, and suggestions for improvements
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Oct 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The investigators propose to perform a hybrid type 2 effectiveness-implementation study with a stepped wedge cluster randomized trial (SW-CRT) design
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Francesca M Nicosia, PhD MA, Principal investigator, San Francisco VA Medical Center, San Francisco, CALinda L. Chao, PhD BS, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972004
- Sponsor's protocol ID
- IIR 23-027
- Other IDs
- 1I01HX003817-01A2, 23-027-02
- Acronym
- PLIE-CLC
- Status last verified
- Oct 2026
- First submitted
- 6 May 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chao LL, Stiep T, Zuzuarregui JRP. Assessing Veterans With Gulf War Illness for Prodromal Parkinson's Disease Risk With the REM Behavioral Sleep Disorder Questionnaire. J Occup Environ Med. 2026 Jan 1;68(1):e7-e16. doi: 10.1097/JOM.0000000000003576. Epub 2025 Oct 17.
PubMed 41102909Chao LL, Torrisi S. Effects of predicted Khamisiyah exposure on default mode network resting state functional connectivity in Gulf War Veterans. Front Toxicol. 2026 Mar 5;8:1772515. doi: 10.3389/ftox.2026.1772515. eCollection 2026.
PubMed 41858729