Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot

Phase 1

Completed

• Conditions: Dementia
• Interventions: Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)

• Registration Number: NCT01371214
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-10
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	PLIÉ (Preventing Loss of Independence through Exercise)	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.
Group 1	PLIÉ (Preventing Loss of Independence through Exercise)	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).

Primary Outcome Measures

Name	Time	Method
Compliance (participant)	Baseline, 18 weeks, 36 weeks	Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks.
Change in number of falls (participant)	Baseline, 18 weeks, 36 weeks	Participant's falls will be assessed based on caregiver report.
Change in fall-related self-efficacy (participant)	Baseline, 18 weeks, 36 weeks	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).
Change in cognitive function (participant)	Baseline, 18 weeks, 36 weeks	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.
Change in dementia-related behaviors (participant)	Baseline, 18 weeks, 36 weeks	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).
Change in functional health and well-being (participant)	Baseline, 18 weeks, 36 weeks	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.
Change in physical function (participant)	Baseline, 18 weeks, 36 weeks	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.
Change in quality of life (participant)	Baseline, 18 weeks, 36 weeks	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.
Change in physical performance (participant)	Baseline, 18 weeks, 36 weeks	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).
Adverse events (participant)	Baseline, 18 weeks, 36 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in burden (caregiver)	Baseline, 18 weeks, 36 weeks	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).
Change in functional health and well-being (caregiver)	Baseline, 18 weeks, 36 weeks	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).

Trial Locations

Locations (1)

Irene Swindells Center for Adult Day Services, Institute on Aging; 🇺🇸 San Francisco, California, United States