Paired Integrative Exercise Program for People With Dementia and Caregivers (Paired PLIÉ)
Status
Conditions
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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