Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot

Study Overview
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Brief Summary
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The primary goal of this study is to perform a 36-week pilot study with a cross-over design to study the safety and efficacy of a novel integrative exercise program called PLIÉ (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and Western exercise traditions and is specifically designed to target the muscles and movements needed to help individuals with mild-to-moderate dementia maintain physical function and independence.

Official Title
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Maintaining Independence in Alzheimer's Disease

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Primary Participant: Current participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA Recommended by Swindells staff mild-to-moderate dementia caregiver consent Inclusion Criteria - Caregiver: Provide care to primary participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA can provide information about the primary participant's physical functioning, behaviors, falls, quality of life and own level of stress. Exclusion Criteria - Primary Participant: major current psychiatric illness (e.g., schizophrenia, bipolar disorder) life expectancy < 1 year (e.g., metastatic cancer) inability to assent to study procedures Exclusion Criteria - Caregiver: Any major neurologic disease (e.g., dementia, stroke, Parkinson's disease, ALS) major current psychiatric illness (e.g., schizophrenia, bipolar disorder) life expectancy < 1 year (e.g., metastatic cancer) evidence of cognitive impairment inability to consent to study procedures.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>PLIÉ exercise program 30-45 minutes, 2-3 days/week for 18 weeks followed by 18 weeks of usual care (20-minutes of chair-based exercises 2-5 days/week). | Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)<br>* Integrative exercise program that incorporates elements of Eastern and Western exercise traditions to target the muscles and movements needed to help individuals with mild to moderate dementia maintain functional status and independence.<br>|
| Active Comparator: Group 2<br>Usual care (20 minutes of chair-based exercises 2-5 days/week) for 18 weeks followed by the PLIÉ exercise program 30-45 minutes/day, 2-3 days/week for 18 weeks. | Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)<br>* Integrative exercise program that incorporates elements of Eastern and Western exercise traditions to target the muscles and movements needed to help individuals with mild to moderate dementia maintain functional status and independence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical function (participant) | Participant's physical function will be assessed with the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale (Galasko 1997). The ADCS-ADL is a 78-point scale that assesses functional ability in 23 daily activities based on informant report. It is the standard measure for assessment of functional status in AD treatment trials. | Baseline, 18 weeks, 36 weeks | 
| Change in quality of life (participant) | Quality of life will be assessed with the Quality of Life Scale in Alzheimer's Disease (QOL-AD), which is a brief, 13-item measure that obtains input from both the individual and the caregiver (Logsdon 1999). Scores may range from 13-52 points. | Baseline, 18 weeks, 36 weeks | 
| Change in functional health and well-being (participant) | Functional health and well-being will be assessed with the SF-36v2, which assesses function in eight domains and provides physical and mental component summary scores that may range from 0 to 70 (Stewart 1989). The SF-36v2 is typically administered directly to participants. However, we also will ask caregivers to answer questions on behalf of participants and will compare their answers to assess congruence. Data collected will help to determine if this measure is suitable for a larger trial. | Baseline, 18 weeks, 36 weeks | 
| Change in number of falls (participant) | Participant's falls will be assessed based on caregiver report. | Baseline, 18 weeks, 36 weeks | 
| Change in fall-related self-efficacy (participant) | Fall-related self-efficacy will be assessed with the Falls Efficacy Scale (FES), which is a 10-item scale that has been validated in individuals with cognitive impairment (Hauer 2010). | Baseline, 18 weeks, 36 weeks | 
| Change in physical performance (participant) | Physical performance will be assessed with the Short Physical Performance Battery (SPPB), which was developed by the National Institute on Aging to provide an objective tool for evaluating lower extremity functioning in older adults. The test includes repeated chair stands, tandem balance testing and 8' walking speed (Guralnik 1994). | Baseline, 18 weeks, 36 weeks | 
| Change in cognitive function (participant) | Cognitive function will be assessed with the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) (Rosen 1984), which is the most commonly used primary outcome measure in AD treatment trials. It is an 80-point scale that includes direct assessment of learning (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. | Baseline, 18 weeks, 36 weeks | 
| Compliance (participant) | Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks. | Baseline, 18 weeks, 36 weeks | 
| Adverse events (participant) | Number of adverse events from baseline to 18 weeks and from 18 weeks to 36 weeks will be monitored through biweekly telephone calls with caregivers. | Baseline, 18 weeks, 36 weeks | 
| Change in dementia-related behaviors (participant) | Participant's dementia-related behaviors will be assessed with the Neuropsychiatric Inventory (NPI), which is a 144-point informant-based questionnaire that assesses 12 behavioral domains common in dementia including frequency, severity and impact on caregiver distress (Cummings 1997). | Baseline, 18 weeks, 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional health and well-being (caregiver) | Caregivers will be asked about the functional health and well-being of themselves as well as participants using the SF-36v2, which assesses function in eight domains and provides physical and mental component summary scores that may range from 0 to 70 (Stewart 1989). | Baseline, 18 weeks, 36 weeks | 
| Change in burden (caregiver) | Caregiver burden will be assessed with the Caregiver Burden Inventory (CBI), which is a 96-point scale that includes 24 items and 5 domains (Novak 1989). | Baseline, 18 weeks, 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, exercise movement techniques, activities of daily living