Paired Integrative Exercise Program for People With Dementia and Caregivers

NCT02729311 | Completed Results

• 1 other identifier: NPSASA-15-364656
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

exercise; function; quality of life; caregiver

Outcome Measures

Primary Outcomes (8)

• Cognitive Function (PWCI, Direct Assessment)

  Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score This was was used to directly assess cognitive function in PWCI. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function.

  12 weeks

• Physical Function (Affected Individual, Direct Assessment)

  Short Physical Performance Battery (SPPB) - total score The Short Physical Performance Battery (SPPB) was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. It includes direct assessment of lower body strength, balance and gait speed that provide a summary score (range 0-12). Higher scores indicate higher performance ability.

  12 weeks

• Quality of Life (Affected Individual, Self-report)

  Quality of life in Alzheimer's disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) asks PWDs to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.

  12 weeks

• Caregiver Burden (Caregiver, Self-report)

  Caregiver Burden Inventory (CBI) - total score This is a standard 24-item measure that includes questions about the CPs feelings about caregiving on a 5-point Likert scale with 5 domains. This measure has good internal consistency. Higher scores (range 0-96) indicate higher burden.

  12 weeks

• Cognitive Function (Affected Individual, Direct Assessment)

  Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to directly assess cognitive function in PWD. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function.

  24 weeks

• Physical Function (Affected Individual, Direct Assessment)

  Short Physical Performance Battery (SPPB) - total score The Short Physical Performance Battery (SPPB) was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. It includes direct assessment of lower body strength, balance and gait speed that provide a summary score (range 0-12). Higher scores indicate higher performance ability

  24 weeks

• Quality of Life (Affected Individual, Self-report)

  Quality of life in Alzheimer's disease (QOL-AD) - total score Quality of life in Alzheimer's disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) asks PWDs to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.

  24 weeks

• Caregiver Burden (Caregiver, Self-report)

  Caregiver Burden Inventory (CBI) - total score Caregiver Burden Inventory (CBI) - total score This is a standard 24-item measure that includes questions about the CPs feelings about caregiving on a 5-point Likert scale with 5 domains. This measure has good internal consistency. Higher scores (range 0-96) indicate higher burden.

  24 weeks

Secondary Outcomes (18)

• Independence (Affected Individual, Caregiver Report)

  12 weeks

• Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)

  12 weeks

• Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report)

  12 weeks

• Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)

  12 weeks

• Falls Efficacy (Affected Individual, Self-report)

  12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Paired PLIÉ Program

Behavioral: Paired PLIÉ Program

Group 2

OTHER

Waitlist control

Behavioral: Paired PLIÉ Program; Behavioral: Waitlist control

Interventions

Paired PLIÉ Program 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 1; Group 2

Waitlist control BEHAVIORAL

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kaiser Permanente: collaborator

Study Sites (1)

Kaiser Oakland

Oakland, California, 94611, United States

Location

Related Publications (4)

• 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.

  PMID: 25671576 BACKGROUND

• 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.

  PMID: 25022459 BACKGROUND

• 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.

  PMID: 30744387 BACKGROUND

• Mehling WE, Scott TM, Duffy J, Whitmer RA, Chesney MA, Boscardin WJ, Barnes DE. Dyadic Group Exercises for Persons with Memory Deficits and Care Partners: Mixed-Method Findings from the Paired Preventing Loss of Independence through Exercise (PLIE) Randomized Trial. J Alzheimers Dis. 2020;78(4):1689-1706. doi: 10.3233/JAD-200713.

  PMID: 33185602 RESULT

Related Links

• Facebook page
• study website

MeSH Terms

Conditions

Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Deborah Barnes, PhD
• Organization: University of California, San Francisco

Deborah.Barnes@ucsf.edu

415-221-4810

Study Officials

• Deborah E Barnes, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 6, 2016
• Study Start: July 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)