Preventing Loss of Independence Through Exercise in Community Living Centers

NCT ID: NCT06972004

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2029-06-30

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.

Detailed Description

Background: Preventing Loss of Independence through Exercise (PLIÉ) is a unique, mind-body, group movement program for people living with cognitive impairment and dementia that has been found to have physical, cognitive, social, and emotional benefits. The investigators received a VA Innovators Award to implement PLIÉ in the San Francisco VA Community Living Center (CLC), where it became one of their most successful and popular programs. As part of the ongoing VA HSR&D pre-implementation grant (1I01 HX002764), the investigators have developed and piloted a remote PLIÉ staff training program and have successfully trained 50 interprofessional staff members at 5 CLCs. This study will enable us to test the effectiveness and implementation of PLIÉ-CLC.

Significance: VA CLCs serve approximately 40,000 Veterans annually, most of whom have one or more severe neurocognitive, mental health or physical impairments; yet CLC staff members typically do not receive specialized training in how to best engage and interact with these Veterans. This training and knowledge gap can result in poor care quality, declines in physical function, increased distressed behaviors, staff burnout, and low morale throughout a facility.

Innovation & Impact: PLIÉ-CLC provides an efficient format for delivering high-quality care to groups of residents with cognitive impairment. Veterans with complex care needs often receive care from different providers who do not necessarily communicate with each other about the residents' needs. PLIÉ-CLC provides a structured framework for interprofessional staff members to work together to simultaneously address residents' physical, social and mental health needs. In addition, PLIÉ-CLC provides an efficient experiential training model. Staff members, trainees and family members are invited to join classes where they can learn by doing and can directly observe the beneficial impact of the classes on residents.

Specific Aims: The goals of this study are to: 1) Determine the effectiveness of PLIÉ-CLC on resident, entered outcomes (primary outcome: physical function; secondary outcomes: social engagement, mood, cognitive function, behaviors, falls, and pain); 2) Determine the effectiveness of PLIÉ-CLC on person-centered care practices and organizational culture, including staff engagement, burnout, and workplace climate; 3) Evaluate implementation of PLIÉ-CLC, including reach, adoption, external facilitation, and fidelity; 4) Examine the extent to which PLIÉ-CLC is sustained after external facilitation support has ended.

Methodology: The investigators proposed to achieve these Specific Aims by performing a Type 2 Hybrid Effectiveness%2Implementation study using a stepped wedge cluster randomized trial design. This design will enable us to assess the effectiveness of PLIÉ-CLC at the resident (Aim 1) and organizational (Aim 2) levels and the implementation process itself at the clinician and organizational levels (Aims 3, 4). The investigators will use a concurrent mixed methods approach to qualitative and quantitative data collection and analysis guided by the Practical, Robust Implementation and Sustainability Model (PRISM).

Next Steps/Implementation: The investigators will work with study partners in the VA Office of Geriatrics and Extended Care, Office of Patient Centered Care & Cultural Transformation, and Mental Health & Suicide Prevention to use the findings from this effectiveness-implementation trial to inform decisions about sustainable roll out and implementation of PLIÉ-CLC nationwide.

Conditions

Dementia; Cognitive Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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. 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).

Group Type: OTHER

Preventing Loss of Independence through Exercise (PLIE)

Intervention Type: 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.

Interventions

Preventing Loss of Independence through Exercise (PLIE)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PLIE-CLC

Eligibility Criteria

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

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesca M Nicosia, PhD MA

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Linda L. Chao, PhD BS

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Locations

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Countries

United States

Other Identifiers

23-027-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1I01HX003817-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IIR 23-027

Identifier Type: -

Identifier Source: org_study_id