Trial Outcomes & Findings for Paired Integrative Exercise Program for People With Dementia and Caregivers (NCT NCT02729311)

Last Updated: 2025-01-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-01-24

Participant Flow

Study participants were recruited using a variety of strategies. We gave presentations at local caregiver support groups; distributed study flyers and brochures to psychiatrists, neurologists, and caregiver support managers; gave presentations at Medical Center Grand Rounds for attending physicians; and posted fliers in community settings and on social media (eg, Facebook).

Exclusion criteria were behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues determined by interview); planning to move to a facility before the end of the study period; terminal illness (life expectancy.

Participant milestones

Participant milestones
Measure	Group 1 Paired PLIÉ Program, immediate start 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 Waitlist control After engaging in usual activities for 12 weeks, the Waitlist control group participated in the Paired PLIÉ Program.
Overall Study STARTED	30	30
Overall Study Completed 12-week Assessment	24	28
Overall Study COMPLETED	22	28
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Paired PLIÉ Program, immediate start 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 Waitlist control After engaging in usual activities for 12 weeks, the Waitlist control group participated in the Paired PLIÉ Program.
Overall Study Withdrawal by Subject	8	2

Baseline Characteristics

This is for participants with cognitive impairment

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Cognitive Function (PWCI, Direct Assessment)	31.78 units on a scale Standard Deviation 11.15	32.60 units on a scale Standard Deviation 13.62

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Physical Function (Affected Individual, Direct Assessment)	6.50 units on a scale Standard Deviation 2.32	6.57 units on a scale Standard Deviation 2.50

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Quality of Life (Affected Individual, Self-report)	41.42 units on a scale Standard Deviation 4.74	40.14 units on a scale Standard Deviation 5.80

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Caregiver Burden (Caregiver, Self-report)	23.27 units on a scale Standard Deviation 11.20	28.85 units on a scale Standard Deviation 16.67

PRIMARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Cognitive Function (Affected Individual, Direct Assessment)	30.97 units on a scale Standard Deviation 11.46	32.67 units on a scale Standard Deviation 11.48

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Physical Function (Affected Individual, Direct Assessment)	6.70 units on a scale Standard Deviation 2.26	6.69 units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Quality of Life (Affected Individual, Self-report)	41.20 units on a scale Standard Deviation 5.45	40.85 units on a scale Standard Deviation 5.81

PRIMARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Caregiver Burden (Caregiver, Self-report)	27.33 units on a scale Standard Deviation 12.73	30.00 units on a scale Standard Deviation 16.64

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Independence (Affected Individual, Caregiver Report)	23.27 units on a scale Standard Deviation 11.20	28.85 units on a scale Standard Deviation 16.67

SECONDARY outcome

Timeframe: 12 weeks

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).

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)	2.25 units on a scale Standard Deviation 1.82	4.43 units on a scale Standard Deviation 3.06

SECONDARY outcome

Timeframe: 12 weeks

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).

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report)	6.50 units on a scale Standard Deviation 7.60	15.69 units on a scale Standard Deviation 16.03

SECONDARY outcome

Timeframe: 12 weeks

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).

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)	4.58 units on a scale Standard Deviation 5.00	11.21 units on a scale Standard Deviation 12.58

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Falls Efficacy (Affected Individual, Self-report)	13.58 units on a scale Standard Deviation 5.35	12.86 units on a scale Standard Deviation 5.33

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Falls Efficacy (Affected Individual, Caregiver Report)	14.17 units on a scale Standard Deviation 5.87	15.29 units on a scale Standard Deviation 7.76

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Quality of Life (Affected Individual, Caregiver Report)	35.42 units on a scale Standard Deviation 4.29	33.00 units on a scale Standard Deviation 7.12

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Mood (Caregiver, Self-report)	1.92 units on a scale Standard Deviation 1.88	2.69 units on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Feelings About Caregiving (Caregiver, Self-report)	43.50 units on a scale Standard Deviation 7.20	44.07 units on a scale Standard Deviation 7.68

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Independence (Affected Individual, Caregiver Report)	64.05 percentage of independence activities Standard Deviation 24.97	59.04 percentage of independence activities Standard Deviation 32.15

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)	2.20 count of symptoms Standard Deviation 2.15	3.93 count of symptoms Standard Deviation 3.12

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report)	4.67 score on a scale Standard Deviation 5.48	12.54 score on a scale Standard Deviation 11.16

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)	4.70 score on a scale Standard Deviation 6.58	9.64 score on a scale Standard Deviation 10.68

SECONDARY outcome

Timeframe: 24 weeks

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).

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Falls Efficacy (Affected Individual, Self-report)	13.40 score on a scale Standard Deviation 4.48	15.93 score on a scale Standard Deviation 9.22

SECONDARY outcome

Timeframe: 24 weeks

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).

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Falls Efficacy (Affected Individual, Caregiver Report)	16.00 score on a scale Standard Deviation 7.13	16.14 score on a scale Standard Deviation 6.70

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Quality of Life (Person With Dementia, Caregiver Report)	32.50 score on a scale Standard Deviation 4.58	32.93 score on a scale Standard Deviation 7.31

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Mood (Caregiver, Self-report)	2.22 score on a scale Standard Deviation 1.20	2.57 score on a scale Standard Deviation 2.77

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1 n=14 Participants Paired PLIÉ Program, immediate start 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 n=15 Participants Paired PLIÉ Program, delayed start 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.
Feelings About Caregiving (Caregiver, Self-report)	39.33 score on a scale Standard Deviation 6.04	42.93 score on a scale Standard Deviation 8.41

Adverse Events

Group 1 - Persons With Cognitive Impairment

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Group 1 - Caregivers

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 2 - Persons With Cognitive Impairment

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 2 - Caregivers

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 - Persons With Cognitive Impairment n=15 participants at risk Paired PLIÉ Program, immediate start - persons with cognitive impairment	Group 1 - Caregivers n=15 participants at risk Paired PLIÉ Program, immediate start - caregivers	Group 2 - Persons With Cognitive Impairment n=15 participants at risk Waitlist control, delayed start - persons with cognitive impairment	Group 2 - Caregivers n=15 participants at risk Waitlist control, delayed start - caregivers
General disorders Emergency visit or hospitalization	13.3% 2/15 • Number of events 2 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	0.00% 0/15 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	6.7% 1/15 • Number of events 1 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	0.00% 0/15 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.

Other adverse events

Other adverse events
Measure	Group 1 - Persons With Cognitive Impairment n=15 participants at risk Paired PLIÉ Program, immediate start - persons with cognitive impairment	Group 1 - Caregivers n=15 participants at risk Paired PLIÉ Program, immediate start - caregivers	Group 2 - Persons With Cognitive Impairment n=15 participants at risk Waitlist control, delayed start - persons with cognitive impairment	Group 2 - Caregivers n=15 participants at risk Waitlist control, delayed start - caregivers
Musculoskeletal and connective tissue disorders Falls / Pain	26.7% 4/15 • Number of events 6 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	0.00% 0/15 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	26.7% 4/15 • Number of events 4 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	6.7% 1/15 • Number of events 1 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.
General disorders Other AEs	13.3% 2/15 • Number of events 2 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	26.7% 4/15 • Number of events 4 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	6.7% 1/15 • Number of events 2 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.	0.00% 0/15 • 24 weeks We asked caregivers to report any major health-related events or falls in themselves or the person with cognitive impairment through monthly telephone check-in calls.

Additional Information

Deborah Barnes, PhD

University of California, San Francisco

Phone: 415-221-4810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 n=30 Participants Paired PLIÉ Program, immediate start 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 n=30 Participants Waitlist control After engaging in usual activities for 12 weeks, the Waitlist control group participated in the Paired PLIÉ Program.	Total n=60 Participants Total of all reporting groups
Age, Continuous	71.6 years STANDARD_DEVIATION 9.7 • n=15 Participants • Care partners only	59.1 years STANDARD_DEVIATION 17.4 • n=15 Participants • Care partners only	60 years STANDARD_DEVIATION 13 • n=30 Participants • Care partners only
Sex: Female, Male Participants with cognitive impairment · Female	7 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	9 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	16 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Sex: Female, Male Participants with cognitive impairment · Male	8 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	6 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	14 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Sex: Female, Male Care partners · Female	10 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	11 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	21 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Sex: Female, Male Care partners · Male	5 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	4 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	9 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Persons with cognitive impairment · American Indian or Alaska Native	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Persons with cognitive impairment · Asian	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	3 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	3 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Persons with cognitive impairment · Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Persons with cognitive impairment · Black or African American	1 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	3 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	4 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Persons with cognitive impairment · White	14 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	8 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	22 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Persons with cognitive impairment · More than one race	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Persons with cognitive impairment · Unknown or Not Reported	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	1 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	1 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Care partners · American Indian or Alaska Native	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Care partners · Asian	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	3 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	3 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Care partners · Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Care partners · Black or African American	2 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	3 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	5 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Care partners · White	12 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	8 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	20 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Care partners · More than one race	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	0 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Race (NIH/OMB) Care partners · Unknown or Not Reported	1 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	1 Participants n=15 Participants • Data for persons with cognitive impairment and care partners analyzed separately	2 Participants n=30 Participants • Data for persons with cognitive impairment and care partners analyzed separately
Region of Enrollment United States	30 participants n=30 Participants	30 participants n=30 Participants	30 participants n=60 Participants
Physical function (SPPB Score) PWCI - direct assessment	6.86 units on a scale STANDARD_DEVIATION 2.66 • n=14 Participants • Measure administered only to persons with cognitive impairment. Data missing for 1 person who withdrew before baseline.	6.53 units on a scale STANDARD_DEVIATION 2.07 • n=15 Participants • Measure administered only to persons with cognitive impairment. Data missing for 1 person who withdrew before baseline.	6.70 units on a scale STANDARD_DEVIATION 2.37 • n=29 Participants • Measure administered only to persons with cognitive impairment. Data missing for 1 person who withdrew before baseline.
Quality of Life (QOL-AD) PWCI - self-report	40.21 units on a scale STANDARD_DEVIATION 5.48 • n=14 Participants • Data collected only in PWCI. Data missing for 1 person who withdrew before baseline.	39.40 units on a scale STANDARD_DEVIATION 5.33 • n=15 Participants • Data collected only in PWCI. Data missing for 1 person who withdrew before baseline.	39.81 units on a scale STANDARD_DEVIATION 5.41 • n=29 Participants • Data collected only in PWCI. Data missing for 1 person who withdrew before baseline.
Cognitive function (ADAS-cog) PWCI - direct assessment	32.21 units on a scale STANDARD_DEVIATION 11.62 • n=14 Participants • Measure administered only to PWCI. Data missing for 1 person who withdrew before baseline.	29.40 units on a scale STANDARD_DEVIATION 9.38 • n=15 Participants • Measure administered only to PWCI. Data missing for 1 person who withdrew before baseline.	30.81 units on a scale STANDARD_DEVIATION 10.50 • n=29 Participants • Measure administered only to PWCI. Data missing for 1 person who withdrew before baseline.
Caregiver burden (CBI) CP - self-report	20.86 units on a scale STANDARD_DEVIATION 9.04 • n=14 Participants • Measure administered only to CPs. Data missing for 1 person who withdrew before baseline.	26.93 units on a scale STANDARD_DEVIATION 14.44 • n=15 Participants • Measure administered only to CPs. Data missing for 1 person who withdrew before baseline.	23.90 units on a scale STANDARD_DEVIATION 11.74 • n=29 Participants • Measure administered only to CPs. Data missing for 1 person who withdrew before baseline.
Balance score (SPPB) PWCI - direct assessment	3.00 units on a scale STANDARD_DEVIATION 1.30 • n=14 Participants • Measure only administered to PWCI. Data missing for 1 person who withdrew before baseline.	2.80 units on a scale STANDARD_DEVIATION 1.08 • n=15 Participants • Measure only administered to PWCI. Data missing for 1 person who withdrew before baseline.	2.90 units on a scale STANDARD_DEVIATION 1.19 • n=29 Participants • Measure only administered to PWCI. Data missing for 1 person who withdrew before baseline.
Independence (DAD) PWCI - CP report	69.98 units on a scale STANDARD_DEVIATION 22.96 • n=14 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	64.60 units on a scale STANDARD_DEVIATION 29.28 • n=15 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	67.29 units on a scale STANDARD_DEVIATION 26.12 • n=29 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.
Falls Efficacy (FES) PWCI - self-report	12.43 units on a scale STANDARD_DEVIATION 3.44 • n=14 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.	12.87 units on a scale STANDARD_DEVIATION 5.55 • n=15 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.	12.65 units on a scale STANDARD_DEVIATION 4.5 • n=29 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.
Falls Efficacy (FES) PWCI - CP report	14.07 units on a scale STANDARD_DEVIATION 5.09 • n=14 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.	16.00 units on a scale STANDARD_DEVIATION 6.49 • n=15 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.	15.04 units on a scale STANDARD_DEVIATION 5.79 • n=29 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.
Caregiving (PAC) CP - self-report	41.93 units on a scale STANDARD_DEVIATION 5.97 • n=14 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	43.67 units on a scale STANDARD_DEVIATION 9.10 • n=15 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	42.8 units on a scale STANDARD_DEVIATION 7.54 • n=29 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.
Quality of life (QOL-AD) PWCI - CP report	35.86 units on a scale STANDARD_DEVIATION 3.37 • n=14 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.	34.40 units on a scale STANDARD_DEVIATION 4.64 • n=15 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.	35.13 units on a scale STANDARD_DEVIATION 4.01 • n=29 Participants • Data analyzed separately for PWCI and CPs. Data missing for 1 person who withdrew before baseline.
Behaviors - frequency (NPI-N) PWCI - CP report	2.64 units on a scale STANDARD_DEVIATION 1.95 • n=14 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	4.20 units on a scale STANDARD_DEVIATION 3.12 • n=15 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	3.42 units on a scale STANDARD_DEVIATION 2.54 • n=29 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.
Behaviors - severity (NPI-FS) PWCI - CP report	7.57 units on a scale STANDARD_DEVIATION 6.17 • n=14 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	13.57 units on a scale STANDARD_DEVIATION 14.90 • n=15 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	10.57 units on a scale STANDARD_DEVIATION 10.54 • n=29 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.
Behaviors - distress (NPI-CD) CP - self-report	4.29 units on a scale STANDARD_DEVIATION 3.43 • n=14 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	9.73 units on a scale STANDARD_DEVIATION 12.29 • n=15 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.	7.01 units on a scale STANDARD_DEVIATION 7.86 • n=29 Participants • Measure only administered to CPs. Data missing for 1 person who withdrew before baseline.