Paired Integrative Exercise Program for People With Dementia and Caregivers

University of California, San Francisco60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dementia

Interventions

Paired PLIÉ ProgramBEHAVIORAL

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 controlBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kaiser Oakland

Oakland, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

Independence (Affected Individual, Caregiver Report)

Disability Assessment for Dementia (DAD) - total score Independence (PWD - CP report). The Disability Assessment for Dementia (DAD)is a standard measure that asks CPs to rate the participant's disability with 17 basic and 23 instrumental activities of daily living over the past 2 weeks. The DAD has high established validity and high test-retest reliability, inter-rater reliability, and internal consistency. Scores represent the percentage of activities performed independently during the past two weeks of those applicable (total number of questions answered yes/total questions applicable)∗100 with the range from 0 to 100. Higher scores indicate greater independence

Time frame: 12 weeks

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

The Neuropsychiatric Inventory (NPI) was administered to assess the number (NPI-N), caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-N scores range from 0-12. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress).

Time frame: 12 weeks

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

Neuropsychiatric Inventory (NPI) - total frequency \* severity measures distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-FS was calculated by multiplying the frequency∗severity of behaviors, which had a range of 0-144. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress).

Time frame: 12 weeks

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

Neuropsychiatric Inventory (NPI) - total distress level of caregiver distress (NPI-CD) caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-CD range from 0-60. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress).

Time frame: 12 weeks

Falls Efficacy (Affected Individual, Self-report)

Falls Efficacy Scale (FES) - total score We administered a modified version of the Falls Efficacy Scale (FES) to assess concern about falling for the PWD in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy). Although the FES has been validated in individuals with cognitive impairment the questionnaire was administered separately to PWD and CPs to obtain their independent perspetive

Time frame: 12 weeks

Falls Efficacy (Affected Individual, Caregiver Report)

Time frame: 12 weeks

Quality of Life (Affected Individual, Caregiver Report)

Quality of Life in Alzheimer's Disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) also asks CPs to rate the PWD current quality of life on the same scale as the PWD QOL self-report. It asks 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.

Time frame: 12 weeks

Mood (Caregiver, Self-report)

Geriatric Depression Scale (GDS) - total score. The Geriatric Depression Scale (GDS) is a standard measure that includes 15 yes/no questions assessing depressive symptomatology over the past week. PWD and CP answered separately regarding their own mood. This scale ranges from 0 to 15 and has been validated in people with and without cognitive impairment. Higher scores indicate more depressive symptoms.

Time frame: 12 weeks

Feelings About Caregiving (Caregiver, Self-report)

Positive Aspects of Caregiving (PAC) - total score. The PAC scale includes 9 questions about the benefits of caregiving noticed by the CPs about themselves, which are rated on a 5-point Likert scale. This measure has high internal consistency and can improve with CP training interventions. Total scores range from 11 to 55 with higher scores indicating more positive feelings.

Time frame: 12 weeks

Independence (Affected Individual, Caregiver Report)

Disability Assessment for Dementia (DAD) - total score. The DAD is a standard measure that asks CPs to rate the participant's disability with 17 basic and 23 instrumental activities of daily living over the past 2 weeks. The DAD has high established validity and high test-retest reliability, inter-rater reliability, and internal consistency. Scores represent the percentage of activities performed independently during the past two weeks of those applicable (total number of questions answered yes/total questions applicable)∗100 with the range from 0 to 100. Higher scores indicate greater independence.

Time frame: 24 weeks

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

Neuropsychiatric Inventory (NPI) - total number of symptoms. The NPI asks CPs to report the number (NPI-N), frequency/severity (NPI-FS), and level of caregiver distress (NPI-CD) caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) and has good test-retest reliability and internal consistency. NPI-N scores range from 0-12.

Time frame: 24 weeks

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

Neuropsychiatric Inventory - Frequency/Severity (NPI-FS). For each behavior present, care partners are asked to rate the frequency (occasionally=1, often=2, frequently=3, very frequently=4) and severity (mild=1, moderate=2, severe=3). The score is obtained by multiplying frequency and severity and adding them for each behavior. Scores may range from 0 to 144 with higher scores indicating more frequent/severe behaviors.

Time frame: 24 weeks

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

Neuropsychiatric Inventory - caregiver distress (NPI-CD). For each behavior, caregivers are asked how emotionally distressing they find the behavior on a scale from 0 (not distressing at all) to 5 (extreme or very severe). Scores may range from 0 to 60 with higher scores indicating greater distress.

Time frame: 24 weeks

Falls Efficacy (Affected Individual, Self-report)

Falls Efficacy Scale (FES) - total score. We administered a modified version of the FES to assess the participant's concern about falling in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy).

Time frame: 24 weeks

Falls Efficacy (Affected Individual, Caregiver Report)

Falls Efficacy Scale (FES) - total score. We administered a modified version of the FES to assess the caregiver's concern about the participant falling in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy).

Time frame: 24 weeks

Quality of Life (Person With Dementia, Caregiver Report)

Quality of Life in Alzheimer's Disease (QOL-AD) - total score. Caregivers were asked to rate the QOL of participants with dementia 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.

Time frame: 24 weeks

Mood (Caregiver, Self-report)

Geriatric Depression Scale (GDS) - total score. The GDS is a standard measure that includes 15 yes/no questions assessing depressive symptomatology over the past week. PWD and CP answered separately regarding their own mood. This scale ranges from 0 to 15 and has been validated in people with and without cognitive impairment. Higher scores indicate more depressive symptoms.

Time frame: 24 weeks

Feelings About Caregiving (Caregiver, Self-report)

Positive Aspects of Caregiving (PAC) - total score. The PAC includes 9 questions about the benefits of caregiving noticed by the CPs about themselves, which are rated on a 5-point Likert scale. This measure has high internal consistency and can improve with CP training interventions. Total scores range from 11 to 55 with higher scores indicating more positive feelings.

Time frame: 24 weeks