Preventing Loss of Independence Through Exercise in Community Living Centers

NCT06972004 | Enrolling By Invitation DMC

• 3 other identifiers: IIR 23-02723-027-021I01HX003817-01A2
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 40,000 older Veterans who have complex care needs (for example, a combination of severe cognitive, physical, and mental health conditions) receive long-term care in VA Community Living Centers (CLCs). However, CLC staff members rarely receive specialized training in how to best engage and interact with these Veterans, which can lead to poor care quality, worsening of symptoms, staff burnout, and low morale throughout a facility. The investigators have developed a unique, mind-body, group movement program for Veterans with cognitive impairment called Preventing Loss of Independence through Exercise (PLIÉ) and found that it has physical, cognitive, social and emotional benefits in CLC residents. The investigators recently taught 50 staff members from a variety of professions in 5 CLCs to lead PLIÉ classes. The study will enable us to test whether the PLIÉ,LC staff training program improves outcomes for residents and to learn about the success and sustainment of the training.

Conditions

Dementia; Cognitive Dysfunction

Keywords

health-related quality of life; Social Participation; Accidental Falls; Pain; Movement; Behavior; neurocognitive disorder; nursing homes; implementation science

Outcome Measures

Primary Outcomes (1)

• 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).

  -6 to 0 months (baseline), 0-6 months, 9 months, 2 months

Secondary Outcomes (17)

• RISE (Staff)

  -6 to 0 months (baseline), 0-6 months, 9 months, 12 months

• MDS (Behavior)

  -6 to 0 months (baseline), 0-6 months, 9 month, 12 months

• MDS (Cognition)

  -6 to 0 months (baseline), 0-6 months, 9 months, 12 months

• MDS (Mood)

  -6 to 0 months (baseline), 0-6 months, 9 months, 12 months

• MDS (Pain)

  -6 to 0 months (baseline), 0-6 months, 9 months, 12 months

Study Arms (1)

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).

Behavioral: Preventing Loss of Independence through Exercise (PLIE)

Interventions

Preventing Loss of Independence through Exercise (PLIE) BEHAVIORAL

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.

Also known as: PLIE-CLC

PLIE-CLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• CLC clinical staff member or volunteer interested in learning to lead PLIÉ-CLC classes
• 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
• Long-stay resident (have resided at the facility for at least 45 days and are not expected to be discharged during the study period)
• Not planning to be discharged within the next 12 months
• Not receiving hospice care.
• Cognitive impairment
• Ability to sit in a standard chair or wheelchair unaided for a 1-hour class
• English language fluency
• 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

You may not qualify if:

• \- Planning to leave the facility in next 12 months
• \- Planning to leave the facility in next 12 months
• Comatose
• Bedbound
• Severe hearing, visual or communication challenges (i.e., unable to hear, see or understand well enough to participate)
• Limited life expectancy (e.g., eligible for hospice)
• Lack of ability to consent/assent to study procedures
• \- Lack of willingness or interest in participating

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Pain; Behavior; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesca M Nicosia, PhD MA

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

• Linda L. Chao, PhD BS

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators propose to perform a hybrid type 2 effectiveness-implementation study with a stepped wedge cluster randomized trial (SW-CRT) design

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)