N/A
Completed N=60
Paired Integrative Exercise Program for People With Dementia and Caregivers
Source: ClinicalTrials.gov NCT02729311 ↗Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Jan 2025
Primary outcomePrimary: Cognitive Function (PWCI, Direct Assessment) — 31.78; 32.60 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Function (PWCI, Direct Assessment) |
31.78; 32.60 | — |
| PRIMARY Physical Function (Affected Individual, Direct Assessment) |
6.70; 6.69 | — |
| PRIMARY Quality of Life (Affected Individual, Self-report) |
41.20; 40.85 | — |
| PRIMARY Caregiver Burden (Caregiver, Self-report) |
27.33; 30.00 | — |
| PRIMARY Cognitive Function (Affected Individual, Direct Assessment) |
30.97; 32.67 | — |
| SECONDARY Independence (Affected Individual, Caregiver Report) |
64.05; 59.04 | — |
| SECONDARY Dementia-related Behaviors - Number (Affected Individual, Caregiver Report) |
2.20; 3.93 | — |
| SECONDARY Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report) |
6.50; 15.69 | — |
| SECONDARY Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report) |
4.70; 9.64 | — |
| SECONDARY Falls Efficacy (Affected Individual, Self-report) |
13.40; 15.93 | — |
| SECONDARY Falls Efficacy (Affected Individual, Caregiver Report) |
16.00; 16.14 | — |
| SECONDARY Quality of Life (Affected Individual, Caregiver Report) |
35.42; 33.00 | — |
| SECONDARY Mood (Caregiver, Self-report) |
2.22; 2.57 | — |
| SECONDARY Feelings About Caregiving (Caregiver, Self-report) |
39.33; 42.93 | — |
| SECONDARY Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report) |
4.67; 12.54 | — |
| SECONDARY Quality of Life (Person With Dementia, Caregiver Report) |
32.50; 32.93 | — |
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
Data sourced from ClinicalTrials.gov (NCT02729311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.