Exercise Program for Cognitive Impairment

(PLIE-CLC Trial)

Overseen By Linda L Chao, PhD BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

288 Participants Needed

Trial Summary

What is the purpose of this trial?

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. We 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. We 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.

Research Team

Francesca M Nicosia, PhD MA

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for older Veterans with complex care needs living in VA Community Living Centers. It's specifically aimed at those who have mild cognitive impairment, dementia, or general cognitive issues. Staff members of these centers are also involved as they will be trained to lead the exercise program.

Inclusion Criteria

CLC directors recommended by VHA leader as likely to be 'early adopter' based on successful implementation of program such as STAR-VA or based on patient population (primarily palliative care or long stay maintenance/custodial care)

I am willing to train, lead classes, track attendance, and join meetings for PLIÉ-CLC.

I am a full-time clinical staff member willing to help with PLIÉ-CLC at my site.

Exclusion Criteria

PLIÉ-CLC staff instructors planning to leave the facility in the next 12 months

CLC internal facilitators/champions planning to leave the facility in the next 12 months

I am a veteran in a CLC and unable to participate in studies due to severe health or communication issues.

Treatment Details

Interventions

• Preventing Loss of Independence through Exercise (PLIE)

Trial Overview The study tests a unique mind-body group movement program called PLIÉ designed for Veterans with cognitive impairments. The goal is to see if training staff to lead PLIÉ classes can improve physical, cognitive, social and emotional outcomes for residents.

Participant Groups

Group I: PLIE-CLC Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+