Paired Integrative Exercise Program for People With Dementia and Caregivers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Paired Integrative Exercise Program for People With Dementia and Caregivers

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Paired PLIÉ Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Paired PLIÉ Program, immediate start | Behavioral: Paired PLIÉ Program<br>* 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.<br>|
| Other: Group 2<br>Paired PLIÉ Program, delayed start | Behavioral: Paired PLIÉ Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function (affected individual, direct assessment) | Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score | 4 months | 
| Physical function (affected individual, direct assessment) | Short Physical Performance Battery (SPPB) - total score | 4 months | 
| Quality of life (affected individual, self-report) | Quality of life in Alzheimer's disease (QOL-AD) - total score | 4 months | 
| Caregiver burden (caregiver, self-report) | Caregiver Burden Inventory (CBI) - total score | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independence (affected individual, caregiver report) | Disability Assessment for Dementia (DAD) - total score | 4 months | 
| Dementia-related behaviors - number (affected individual, caregiver report) | Neuropsychiatric Inventory (NPI) - total number of symptoms | 4 months | 
| Dementia-related behaviors - severity (affected individual, caregiver report) | Neuropsychiatric Inventory (NPI) - total frequency * severity | 4 months | 
| Dementia-related behaviors - caregiver distress (caregiver, self-report) | Neuropsychiatric Inventory (NPI) - total distress | 4 months | 
| Falls efficacy (affected individual, self-report) | Falls Efficacy Scale (FES) - total score | 4 months | 
| Falls efficacy (affected individual, caregiver report) | Falls Efficacy Scale (FES) - total score | 4 months | 
| Quality of life (affected individual, caregiver report) | Quality of Life in Alzheimer's Disease (QOL-AD) - total score | 4 months | 
| Incontinence (affected individual, caregiver report) | Frequency - days past 4 weeks | 4 months | 
| Incontinence (affected individual, caregiver report) | Degree of problem - total score | 4 months | 
| Mood (caregiver, self-report) | Geriatric Depression Scale (GDS) - total score | 4 months | 
| Feelings about caregiving (caregiver, self-report) | Positive Aspects of Caregiving (PAC) - total score | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, function, quality of life, caregiver