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Paired Integrative Exercise Program for People With Dementia and Caregivers (Paired PLIÉ)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paired PLIÉ Program
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring exercise, function, quality of life, caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Oakland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group 1

Group 2

Arm Description

Paired PLIÉ Program, immediate start

Paired PLIÉ Program, delayed start

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2016
Last Updated
April 2, 2019
Sponsor
University of California, San Francisco
Collaborators
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02729311
Brief Title
Paired Integrative Exercise Program for People With Dementia and Caregivers
Acronym
Paired PLIÉ
Official Title
Paired Integrative Exercise Program for People With Dementia and Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
exercise, function, quality of life, caregiver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Paired PLIÉ Program, immediate start
Arm Title
Group 2
Arm Type
Other
Arm Description
Paired PLIÉ Program, delayed start
Intervention Type
Behavioral
Intervention Name(s)
Paired PLIÉ Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive function (affected individual, direct assessment)
Description
Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score
Time Frame
4 months
Title
Physical function (affected individual, direct assessment)
Description
Short Physical Performance Battery (SPPB) - total score
Time Frame
4 months
Title
Quality of life (affected individual, self-report)
Description
Quality of life in Alzheimer's disease (QOL-AD) - total score
Time Frame
4 months
Title
Caregiver burden (caregiver, self-report)
Description
Caregiver Burden Inventory (CBI) - total score
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Independence (affected individual, caregiver report)
Description
Disability Assessment for Dementia (DAD) - total score
Time Frame
4 months
Title
Dementia-related behaviors - number (affected individual, caregiver report)
Description
Neuropsychiatric Inventory (NPI) - total number of symptoms
Time Frame
4 months
Title
Dementia-related behaviors - severity (affected individual, caregiver report)
Description
Neuropsychiatric Inventory (NPI) - total frequency * severity
Time Frame
4 months
Title
Dementia-related behaviors - caregiver distress (caregiver, self-report)
Description
Neuropsychiatric Inventory (NPI) - total distress
Time Frame
4 months
Title
Falls efficacy (affected individual, self-report)
Description
Falls Efficacy Scale (FES) - total score
Time Frame
4 months
Title
Falls efficacy (affected individual, caregiver report)
Description
Falls Efficacy Scale (FES) - total score
Time Frame
4 months
Title
Quality of life (affected individual, caregiver report)
Description
Quality of Life in Alzheimer's Disease (QOL-AD) - total score
Time Frame
4 months
Title
Incontinence (affected individual, caregiver report)
Description
Frequency - days past 4 weeks
Time Frame
4 months
Title
Incontinence (affected individual, caregiver report)
Description
Degree of problem - total score
Time Frame
4 months
Title
Mood (caregiver, self-report)
Description
Geriatric Depression Scale (GDS) - total score
Time Frame
4 months
Title
Feelings about caregiving (caregiver, self-report)
Description
Positive Aspects of Caregiving (PAC) - total score
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Serious adverse events - total number
Time Frame
4 months
Title
Adherence
Description
Number of classes attended
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah E Barnes, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25671576
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.
Results Reference
background
PubMed Identifier
25022459
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.
Results Reference
background
PubMed Identifier
30744387
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.
Results Reference
result
Links:
URL
https://www.facebook.com/plie4dementia/
Description
Facebook page
URL
http://plie4dementia.com/
Description
study website

Learn more about this trial

Paired Integrative Exercise Program for People With Dementia and Caregivers

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