Clinical trial NCT02729311: Paired Integrative Exercise Program for People With Dementia and Caregivers
Official title: Paired Integrative Exercise Program for People With Dementia and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: exercise
function
quality of life
caregiver
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2016-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Study participants are 30 pairs of individuals with mild-to-moderate dementia and their primary care partners (N=60 total) 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.

Eligibility criteria: Inclusion Criteria: Person with Cognitive Impairment

* 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 Partner

* provide care for person with cognitive impairment
* willing and able to engage in study procedures
* English language fluency

Exclusion Criteria: Person with cognitive impairment

* 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 Partner

* 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

Primary outcomes:
measure: Cognitive Function (PWCI, Direct Assessment)
timeFrame: 12 weeks
measure: Physical Function (Affected Individual, Direct Assessment)
timeFrame: 12 weeks
measure: Quality of Life (Affected Individual, Self-report)
timeFrame: 12 weeks
measure: Caregiver Burden (Caregiver, Self-report)
timeFrame: 12 weeks
measure: Cognitive Function (Affected Individual, Direct Assessment)
timeFrame: 24 weeks
measure: Physical Function (Affected Individual, Direct Assessment)
timeFrame: 24 weeks
measure: Quality of Life (Affected Individual, Self-report)
timeFrame: 24 weeks
measure: Caregiver Burden (Caregiver, Self-report)
timeFrame: 24 weeks
Secondary outcomes:
measure: Independence (Affected Individual, Caregiver Report)
timeFrame: 12 weeks
measure: Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)
timeFrame: 12 weeks
measure: Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report)
timeFrame: 12 weeks
measure: Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)
timeFrame: 12 weeks
measure: Falls Efficacy (Affected Individual, Self-report)
timeFrame: 12 weeks
measure: Falls Efficacy (Affected Individual, Caregiver Report)
timeFrame: 12 weeks
measure: Quality of Life (Affected Individual, Caregiver Report)
timeFrame: 12 weeks
measure: Mood (Caregiver, Self-report)
timeFrame: 12 weeks
measure: Feelings About Caregiving (Caregiver, Self-report)
timeFrame: 12 weeks
measure: Independence (Affected Individual, Caregiver Report)
timeFrame: 24 weeks
measure: Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)
timeFrame: 24 weeks
measure: Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report)
timeFrame: 24 weeks
measure: Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)
timeFrame: 24 weeks
measure: Falls Efficacy (Affected Individual, Self-report)
timeFrame: 24 weeks
measure: Falls Efficacy (Affected Individual, Caregiver Report)
timeFrame: 24 weeks
measure: Quality of Life (Person With Dementia, Caregiver Report)
timeFrame: 24 weeks
measure: Mood (Caregiver, Self-report)
timeFrame: 24 weeks
measure: Feelings About Caregiving (Caregiver, Self-report)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Oakland
state: California
Study officials:
affiliation: University of California, San Francisco
name: Deborah E Barnes, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): 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.
citation: Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): 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.
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 PLIE): initial process evaluation. Aging Ment Health. 2020 Jun;24(6):971-977. doi: 10.1080/13607863.2018.1553142. Epub 2019 Feb 12.
citation: Mehling WE, Scott TM, Duffy J, Whitmer RA, Chesney MA, Boscardin WJ, Barnes DE. Dyadic Group Exercises for Persons with Memory Deficits and Care Partners: Mixed-Method Findings from the Paired Preventing Loss of Independence through Exercise (PLIE) Randomized Trial. J Alzheimers Dis. 2020;78(4):1689-1706. doi: 10.3233/JAD-200713.