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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729311
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Deborah Barnes, University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Paired PLIÉ Program Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paired Integrative Exercise Program for People With Dementia and Caregivers
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Paired PLIÉ Program, immediate start
 Behavioral: 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.
Group 2
Paired PLIÉ Program, delayed start
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive function (affected individual, direct assessment) [ Time Frame: 4 months ]
    Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score

  2. Physical function (affected individual, direct assessment) [ Time Frame: 4 months ]
    Short Physical Performance Battery (SPPB) - total score

  3. Quality of life (affected individual, self-report) [ Time Frame: 4 months ]
    Quality of life in Alzheimer's disease (QOL-AD) - total score

  4. Caregiver burden (caregiver, self-report) [ Time Frame: 4 months ]
    Caregiver Burden Inventory (CBI) - total score


Secondary Outcome Measures :
  1. Independence (affected individual, caregiver report) [ Time Frame: 4 months ]
    Disability Assessment for Dementia (DAD) - total score

  2. Dementia-related behaviors - number (affected individual, caregiver report) [ Time Frame: 4 months ]
    Neuropsychiatric Inventory (NPI) - total number of symptoms

  3. Dementia-related behaviors - severity (affected individual, caregiver report) [ Time Frame: 4 months ]
    Neuropsychiatric Inventory (NPI) - total frequency * severity

  4. Dementia-related behaviors - caregiver distress (caregiver, self-report) [ Time Frame: 4 months ]
    Neuropsychiatric Inventory (NPI) - total distress

  5. Falls efficacy (affected individual, self-report) [ Time Frame: 4 months ]
    Falls Efficacy Scale (FES) - total score

  6. Falls efficacy (affected individual, caregiver report) [ Time Frame: 4 months ]
    Falls Efficacy Scale (FES) - total score

  7. Quality of life (affected individual, caregiver report) [ Time Frame: 4 months ]
    Quality of Life in Alzheimer's Disease (QOL-AD) - total score

  8. Incontinence (affected individual, caregiver report) [ Time Frame: 4 months ]
    Frequency - days past 4 weeks

  9. Incontinence (affected individual, caregiver report) [ Time Frame: 4 months ]
    Degree of problem - total score

  10. Mood (caregiver, self-report) [ Time Frame: 4 months ]
    Geriatric Depression Scale (GDS) - total score

  11. Feelings about caregiving (caregiver, self-report) [ Time Frame: 4 months ]
    Positive Aspects of Caregiving (PAC) - total score


Other Outcome Measures:
  1. Adverse events [ Time Frame: 4 months ]
    Serious adverse events - total number

  2. Adherence [ Time Frame: 4 months ]
    Number of classes attended


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729311


Locations
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United States, California
Kaiser Oakland
Oakland, California, United States, 94611
Sponsors and Collaborators
University of California, San Francisco
Kaiser Permanente
Investigators
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Principal Investigator: Deborah E Barnes, PhD, MPH University of California, San Francisco
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Deborah Barnes, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02729311    
Other Study ID Numbers: NPSASA-15-364656
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Deborah Barnes, University of California, San Francisco:
exercise
function
quality of life
caregiver
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders