Paired Integrative Exercise Program for People With Dementia and Caregivers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adapted Lifestyle-integrated Functional Exercise Program for Medically Underserved Older Adults

NCT03704194

Accidental Fall

COMPLETED NA

Living Independence Through Functional Training

NCT07125378

Mobility Limitation Cognitive Impairment

RECRUITING PHASE1/PHASE2

Exercise for Adults With Limited Mobility

NCT05266573

Mobility Limitation Fall

COMPLETED NA

Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome

NCT06537648

Down Syndrome Physical Inactivity

COMPLETED NA

The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

NCT05712395

Claudication Peripheral Artery Disease

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Paired PLIÉ Program

Group Type EXPERIMENTAL

Paired PLIÉ Program

Intervention Type BEHAVIORAL

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.

Group 2

Waitlist control

Group Type OTHER

Paired PLIÉ Program

Intervention Type BEHAVIORAL

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.

Waitlist control

Intervention Type BEHAVIORAL

After engaging in usual activities for 12 weeks, the Waitlist control group participates in the Paired PLIÉ program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Waitlist control

After engaging in usual activities for 12 weeks, the Waitlist control group participates in the Paired PLIÉ program.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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

Exclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No