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

Disqualifiers: Comatose, Bedbound, Severe communication challenges, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special exercise program, called Preventing Loss of Independence through Exercise (PLIE), can assist older Veterans with memory and thinking problems. The program combines physical movement with mental engagement to enhance overall well-being. The trial will train staff to lead these exercises and assess their benefits for both residents and staff in Community Living Centers. Veterans living in these centers for at least 45 days, who can sit in a chair or wheelchair for an hour, might be suitable participants. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve the quality of life for many Veterans.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this exercise program is safe for Veterans with cognitive impairment?

Research has shown that the Preventing Loss of Independence through Exercise (PLIÉ) program is generally safe for individuals with memory and thinking problems. Studies have found that PLIÉ can enhance thinking skills, physical abilities, and overall quality of life. Importantly, no major negative effects have been reported from the program.

The program includes gentle exercises that connect the mind and body, ensuring safety and benefit for participants. While any exercise carries some risks, participants in past studies have responded well to PLIÉ. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PLIE program for cognitive impairment because it takes a unique approach by combining mind-body exercises in a social group setting. Unlike traditional treatments for dementia that often focus on medication, PLIE emphasizes improving participants' quality of life through movement and mindfulness, which can enhance both physical and mental well-being. This innovative approach could potentially empower individuals with dementia by maintaining their independence and improving their daily functioning in a supportive community environment.

What evidence suggests that the PLIÉ program is effective for cognitive impairment?

Research shows that the Preventing Loss of Independence through Exercise (PLIÉ) program, which participants in this trial will receive, can assist people with memory and thinking problems. Studies have found that participants experience mental and physical improvements and enhanced social interactions. Communication between different parts of the brain also improves. This suggests that PLIÉ might help older adults facing these challenges maintain independence and enhance their overall quality of life. ^{1 5 6 7 8}

Who Is on the Research Team?

Francesca M Nicosia, PhD MA

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Linda L. Chao, PhD BS

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data collection phase where no clusters are exposed to the intervention

6 months

Intervention

Sequential randomized crossover to the PLIÉ-CLC intervention

6 months

Follow-up

Participants are monitored for effectiveness and sustainment of the PLIÉ-CLC program

6 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8461710/

Preventing Loss of Independence through Exercise (PLIÉ) To investigate whether PLIÉ would benefit cognitive and behavioral outcomes and functional brain connectivity in older adults with milder forms ...

2. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.046156

Preventing Loss of Independence through Exercise (PLIÉ ... Respondents reported improvements in themselves and/or others in four domains: 1) psychological, 2) physical, 3) cognitive, and 4) social.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01371214

Study Details | NCT01371214 | Preventing Loss of ... The primary goal of this study is to perform a 36-week pilot study with a cross-over design to study the safety and efficacy of a novel integrative exercise ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06972004

Preventing Loss of Independence Through Exercise in ... A unique, mind-body, group movement program for people living with cognitive impairment and dementia that has been found to have physical, cognitive, social, ...

5. researchgate.net researchgate.net/publication/263934747_Preventing_Loss_of_Independence_through_Exercise_PLIE_A_Pilot_Clinical_Trial_in_Older_Adults_with_Dementia

A Pilot Clinical Trial in Older Adults with Dementia Conclusions: These qualitative results suggest that the PLIÉ program may be associated with beneficial functional, emotional, and social changes ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.042345

Preventing loss of independence through exercise (PLIÉ) for ... Our primary outcomes in participants were physical performance, cognitive function, and self-rated quality of life. Secondary outcomes included ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03526146

Preventing Loss of Independence Through Exercise (PLIÉ) in ... Moreover, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia and MCI.

8. neurology.org neurology.org/doi/10.1212/WNL.80.7_supplement.S24.007

Preventing Loss of Independence through Exercise (PLIÉ) ADAS-cog scores improved 4.6 points (27.0 to 22.4) with PLIÉ and worsened 2.4 points (23.7 to 26.1) with usual care (effect size, 0.76). Gait ...