Paired Integrative Exercise Program for People With Dementia and Caregivers

Dementia Clinical Trial

— Paired PLIÉ  

Official title:

Paired Integrative Exercise Program for People With Dementia and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729311
• Other study ID #: NPSASA-15-364656
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Preventing Loss of Independence through Exercise (PLIÉ) is a unique, multimodal movement program for people with dementia (affected individuals) that is taught by trained instructors and combines physical, mental and social activities. The Paired PLIÉ Program is an adapted version designed for pairs of affected individuals and care partners. The goal of this study is to perform a randomized, controlled trial (RCT) with a delayed start design to examine the effects of the Paired PLIÉ Program on function and quality of life in affected individuals and care partners.

Description:

Study participants are 60 pairs of individuals with mild-to-moderate dementia and their primary care partners who are randomly assigned to Group 1 (immediate start) or Group 2 (delayed start). Pairs randomized to Group 1 participate together in the Paired PLIÉ program 2 days/week for 12 weeks (24 classes total) while pairs randomized to Group 2 continue with their usual activities. Then Group 1 transitions into a maintenance phase, and Group 2 participates in the Paired PLIÉ program 2 days/week for 12 weeks. Outcome data are collected in all study participants at baseline, mid-point and end-point so that we can examine the initial impact of the program as well as whether effects are maintained in Group 1. Outcome measures include cognitive function, physical performance, quality of life and caregiver well-being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Affected Individuals

• diagnosis of cognitive impairment or dementia

• mild to moderate severity, defined as Clinical Dementia Rating of 0.5, 1 or 2

• willing and able to engage in study procedures

• English language fluency

Inclusion Criteria: Care Partners

• provide care for affected individual

• willing and able to engage in study procedures

• English language fluency

Exclusion Criteria: Affected Individuals

• planning to miss more than 2 weeks during the study period

• behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues)

• unable to take 2 steps independently without cane or walker

• terminal illness (life expectancy < 1 year)

• currently participating in another research study that could impact current study

• changes to dementia medications 3 months prior to baseline or changes planned during the study period

Exclusion Criteria: Care Partners

• planning to miss more than 2 weeks during the study period

• behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues)

• unable to take 2 steps independently without cane or walker

• terminal illness (life expectancy < 1 year)

• currently participating in another research study that could impact current study

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Paired PLIÉ Program
The Paired PLIÉ Program is a novel, multimodal, movement program that focuses on abilities that are well maintained in people with dementia, including training procedural ('muscle') memory for basic daily movements, in-the-moment mindful body awareness, and social engagement. Group classes are held with affected individuals, care partners and instructors together. A monthly home visit also is provided.

Locations

Country	Name	City	State
United States	Kaiser Oakland	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIÉ): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015. — View Citation

Casey JJ, Harrison KL, Ventura MI, Mehling W, Barnes DE. An integrative group movement program for people with dementia and care partners together (Paired PLIÉ): initial process evaluation. Aging Ment Health. 2019 Feb 12:1-7. doi: 10.1080/13607863.2018.15 — View Citation

Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIÉ): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Serious adverse events - total number	4 months
Other	Adherence	Number of classes attended	4 months
Primary	Cognitive function (affected individual, direct assessment)	Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score	4 months
Primary	Physical function (affected individual, direct assessment)	Short Physical Performance Battery (SPPB) - total score	4 months
Primary	Quality of life (affected individual, self-report)	Quality of life in Alzheimer's disease (QOL-AD) - total score	4 months
Primary	Caregiver burden (caregiver, self-report)	Caregiver Burden Inventory (CBI) - total score	4 months
Secondary	Independence (affected individual, caregiver report)	Disability Assessment for Dementia (DAD) - total score	4 months
Secondary	Dementia-related behaviors - number (affected individual, caregiver report)	Neuropsychiatric Inventory (NPI) - total number of symptoms	4 months
Secondary	Dementia-related behaviors - severity (affected individual, caregiver report)	Neuropsychiatric Inventory (NPI) - total frequency * severity	4 months
Secondary	Dementia-related behaviors - caregiver distress (caregiver, self-report)	Neuropsychiatric Inventory (NPI) - total distress	4 months
Secondary	Falls efficacy (affected individual, self-report)	Falls Efficacy Scale (FES) - total score	4 months
Secondary	Falls efficacy (affected individual, caregiver report)	Falls Efficacy Scale (FES) - total score	4 months
Secondary	Quality of life (affected individual, caregiver report)	Quality of Life in Alzheimer's Disease (QOL-AD) - total score	4 months
Secondary	Incontinence (affected individual, caregiver report)	Frequency - days past 4 weeks	4 months
Secondary	Incontinence (affected individual, caregiver report)	Degree of problem - total score	4 months
Secondary	Mood (caregiver, self-report)	Geriatric Depression Scale (GDS) - total score	4 months
Secondary	Feelings about caregiving (caregiver, self-report)	Positive Aspects of Caregiving (PAC) - total score	4 months

External Links

•   Facebook page
•   study website